FORTIFY DR, U1.6 SJ4 US

IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

This device is manufactured by ABBOTT, ST JUDE MEDICAL, ST JUDE MEDICAL (CRM-SUNNYVALE), ST JUDE MEDICAL (CRM-SYLMAR), ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION, ST JUDE MEDICAL PUERTO RICO.

The following problems were reported about this device:

Date Event Type Patient Problem Device Problem
2024-07-25 Death Insufficient Information None
2024-04-04 Malfunction No Clinical Signs, Symptoms or Conditions Under-Sensing
2024-02-26 Malfunction No Clinical Signs, Symptoms or Conditions None
2023-07-17 Malfunction No Clinical Signs, Symptoms or Conditions Inappropriate/Inadequate Shock/Stimulation, Inappropriate or Unexpected Reset
2023-01-24 Malfunction Insufficient Information Defective Device
2023-01-18 Malfunction No Clinical Signs, Symptoms or Conditions Environmental Compatibility Problem, Inappropriate or Unexpected Reset
2023-01-05 Injury Unspecified Infection Adverse Event Without Identified Device or Use Problem
2022-09-13 Injury No Clinical Signs, Symptoms or Conditions Premature Discharge of Battery
2022-09-13 Injury None Premature Discharge of Battery
2020-03-10 Injury None Appropriate Term/Code Not Available
2020-02-25 Injury None Appropriate Term/Code Not Available
2019-10-14 Injury None Inappropriate/Inadequate Shock/Stimulation
2019-09-10 Injury None Inappropriate or Unexpected Reset
2019-09-09 Malfunction None Inappropriate or Unexpected Reset
2019-09-08 Injury None Premature Discharge of Battery, Battery Problem
2019-09-04 Injury None Battery Problem
2019-09-04 Injury None Incorrect Interpretation of Signal, Inappropriate/Inadequate Shock/Stimulation
2019-09-03 Injury None Premature Discharge of Battery, Battery Problem
2019-09-03 Injury None Premature Discharge of Battery, Battery Problem
2019-09-03 Injury None Battery Problem
2019-09-02 Injury None Premature Discharge of Battery, Battery Problem
2019-09-02 Malfunction None Use of Incorrect Control/Treatment Settings, Failure to Deliver Shock/Stimulation
2019-09-01 Injury None Battery Problem
2019-09-01 Injury None Battery Problem
2019-09-01 Injury None Battery Problem
2019-08-30 Injury None Battery Problem
2019-08-27 Injury None Inappropriate/Inadequate Shock/Stimulation
2019-08-25 Malfunction None Inappropriate/Inadequate Shock/Stimulation
2019-08-16 Injury None Premature Discharge of Battery, Battery Problem
2019-08-14 Injury None Incorrect Interpretation of Signal, Inappropriate/Inadequate Shock/Stimulation
2019-08-08 Injury None Signal Artifact/Noise, Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2019-08-04 Injury None Battery Problem
2019-08-03 Death None Adverse Event Without Identified Device or Use Problem
2019-08-02 Injury None Battery Problem
2019-07-30 Malfunction None Battery Problem
2019-07-27 Injury None Failure to Interrogate, Inappropriate/Inadequate Shock/Stimulation, Inappropriate or Unexpected Reset
2019-07-26 Injury None Battery Problem
2019-07-25 Malfunction None Failure to Interrogate
2019-07-22 Injury None Premature Discharge of Battery, Failure to Interrogate
2019-07-19 Malfunction None Communication or Transmission Problem
2019-07-18 Injury None Battery Problem
2019-07-16 Malfunction None Over-Sensing
2019-07-15 Injury None Battery Problem
2019-07-15 Injury None Battery Problem
2019-07-14 Injury None Battery Problem
2019-07-13 Injury None Incorrect Interpretation of Signal, Inappropriate/Inadequate Shock/Stimulation
2019-07-12 Injury None Battery Problem
2019-07-11 Injury None Battery Problem
2019-07-10 Injury None Incorrect Interpretation of Signal, Inappropriate/Inadequate Shock/Stimulation
2019-07-10 Malfunction None Failure to Capture, Capturing Problem
2019-07-09 Malfunction None Battery Problem
2019-07-08 Malfunction None Over-Sensing
2019-07-03 Injury None Battery Problem
2019-07-02 Injury None Battery Problem
2019-07-02 Injury None Battery Problem
2019-07-01 Injury None Premature Discharge of Battery, Battery Problem
2019-06-30 Injury None Battery Problem
2019-06-25 Injury None Battery Problem
2019-06-24 Injury None Incorrect Interpretation of Signal
2019-06-24 Malfunction None Battery Problem
2019-06-20 Malfunction None Over-Sensing
2019-06-20 Injury None Battery Problem
2019-06-20 Malfunction None Data Problem
2019-06-19 Injury None Battery Problem
2019-06-16 Injury None Battery Problem
2019-06-15 Injury None Incorrect Interpretation of Signal, Inappropriate/Inadequate Shock/Stimulation
2019-06-14 Injury None Battery Problem
2019-06-13 Injury None Battery Problem
2019-06-13 Malfunction None Failure to Deliver Shock/Stimulation, Under-Sensing
2019-06-12 Injury None Premature Discharge of Battery, Battery Problem
2019-06-11 Malfunction None Image Display Error/Artifact, Appropriate Term/Code Not Available
2019-06-10 Injury None Battery Problem
2019-06-06 Injury None Battery Problem
2019-06-06 Injury None Adverse Event Without Identified Device or Use Problem
2019-06-05 Malfunction None Wireless Communication Problem
2019-06-02 Malfunction None Failure to Charge
2019-05-31 Injury None Defective Alarm, Premature Discharge of Battery, Failure to Interrogate
2019-05-29 Injury None Battery Problem
2019-05-24 Injury None Adverse Event Without Identified Device or Use Problem
2019-05-22 Injury None Battery Problem
2019-05-22 Injury None Battery Problem
2019-05-18 Malfunction None Signal Artifact/Noise, Over-Sensing
2019-05-15 Injury None Signal Artifact/Noise, Over-Sensing
2019-05-13 Injury None Premature Discharge of Battery
2019-05-10 Injury None Premature Discharge of Battery, Battery Problem
2019-05-09 Injury None Appropriate Term/Code Not Available
2019-05-09 Injury None Battery Problem
2019-05-07 Injury None Battery Problem
2019-05-04 Malfunction None Battery Problem
2019-05-02 Injury None Inappropriate or Unexpected Reset
2019-04-30 Malfunction None Signal Artifact/Noise
2019-04-29 Injury None Premature Discharge of Battery, Battery Problem
2019-04-29 Malfunction None Under-Sensing
2019-04-28 Injury None Inappropriate/Inadequate Shock/Stimulation
2019-04-25 Injury None Adverse Event Without Identified Device or Use Problem
2019-04-25 Injury None Battery Problem
2019-04-24 Malfunction None Over-Sensing
2019-04-24 Injury None Battery Problem
2019-04-18 Injury None Battery Problem
2019-04-15 Death None Adverse Event Without Identified Device or Use Problem
2019-04-15 Injury None Battery Problem
2019-04-15 Injury None Failure to Interrogate, Battery Problem
2019-04-10 Injury None Inappropriate/Inadequate Shock/Stimulation
2019-04-10 Injury None Inappropriate/Inadequate Shock/Stimulation, Under-Sensing
2019-04-10 Malfunction None Failure to Interrogate, Wireless Communication Problem
2019-04-09 Injury None Failure to Interrogate
2019-04-08 Injury None Premature Discharge of Battery, Failure to Interrogate
2019-04-08 Injury None Battery Problem
2019-04-08 Injury None Battery Problem
2019-04-05 Injury None Battery Problem
2019-04-04 Injury None Incorrect Measurement
2019-04-01 Injury None Adverse Event Without Identified Device or Use Problem
2019-03-31 Injury None Inappropriate/Inadequate Shock/Stimulation
2019-03-28 Malfunction None Adverse Event Without Identified Device or Use Problem
2019-03-28 Injury None Battery Problem
2019-03-27 Malfunction None Adverse Event Without Identified Device or Use Problem
2019-03-26 Injury None Premature Discharge of Battery, Failure to Interrogate, Battery Problem
2019-03-26 Injury None Battery Problem
2019-03-26 Injury None Inappropriate or Unexpected Reset
2019-03-26 Injury None Premature Discharge of Battery, Failure to Interrogate, Battery Problem
2019-03-25 Malfunction None Failure to Capture, Over-Sensing
2019-03-25 Injury None Adverse Event Without Identified Device or Use Problem
2019-03-21 Injury None Failure to Interrogate
2019-03-19 Injury None Adverse Event Without Identified Device or Use Problem
2019-03-18 Injury None Adverse Event Without Identified Device or Use Problem
2019-03-15 Malfunction None Battery Problem
2019-03-15 Injury None Failure to Interrogate, No Pacing
2019-03-13 Injury None Battery Problem
2019-03-12 Injury None Adverse Event Without Identified Device or Use Problem
2019-03-12 Injury None Battery Problem
2019-03-11 Injury None Battery Problem
2019-03-11 Injury None Premature Discharge of Battery, Battery Problem
2019-03-11 Injury None Adverse Event Without Identified Device or Use Problem
2019-03-06 Injury None Battery Problem
2019-03-05 Injury None Defective Alarm, Premature Discharge of Battery, Failure to Interrogate, No Pacing
2019-02-27 Injury None Retraction Problem
2019-02-23 Malfunction None Battery Problem
2019-02-20 Injury None Battery Problem
2019-02-15 Malfunction None Over-Sensing
2019-02-14 Injury None Premature Discharge of Battery
2019-02-13 Malfunction None Telemetry Discrepancy
2019-02-09 Injury None Battery Problem
2019-02-05 Injury None Battery Problem
2019-02-05 Injury None Adverse Event Without Identified Device or Use Problem
2019-02-04 Injury None Inappropriate/Inadequate Shock/Stimulation
2019-02-04 Malfunction None Signal Artifact/Noise, Over-Sensing
2019-02-02 Malfunction None Defective Alarm
2019-02-02 Injury None Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2019-01-30 Injury None Premature Discharge of Battery, Failure to Interrogate
2019-01-29 Injury None Battery Problem
2019-01-29 Injury None Battery Problem
2019-01-28 Injury None Failure to Interrogate
2019-01-27 Injury None Inappropriate/Inadequate Shock/Stimulation
2019-01-26 Injury None Premature Discharge of Battery, Battery Problem
2019-01-21 Injury None Battery Problem
2019-01-18 Injury None Adverse Event Without Identified Device or Use Problem
2019-01-18 Malfunction None Premature Discharge of Battery, Battery Problem
2019-01-17 Injury None Battery Problem
2019-01-17 Injury None Signal Artifact/Noise, Over-Sensing, Fitting Problem
2019-01-15 Injury None Battery Problem
2019-01-15 Injury None Failure to Charge
2019-01-14 Injury None Adverse Event Without Identified Device or Use Problem
2019-01-14 Injury None Battery Problem
2019-01-14 Malfunction None Battery Problem
2019-01-11 Injury None Adverse Event Without Identified Device or Use Problem
2019-01-09 Injury None Battery Problem
2019-01-09 Injury None Incorrect Interpretation of Signal, Inappropriate/Inadequate Shock/Stimulation
2019-01-07 Injury None Battery Problem
2019-01-04 Injury None Premature Discharge of Battery, Battery Problem
2019-01-04 Injury None Adverse Event Without Identified Device or Use Problem
2019-01-04 Malfunction None Adverse Event Without Identified Device or Use Problem
2019-01-02 Injury None Battery Problem
2018-12-29 Injury None Inappropriate/Inadequate Shock/Stimulation
2018-12-28 Malfunction None Adverse Event Without Identified Device or Use Problem
2018-12-28 Malfunction None Adverse Event Without Identified Device or Use Problem
2018-12-28 Malfunction None Adverse Event Without Identified Device or Use Problem
2018-12-26 Malfunction None Adverse Event Without Identified Device or Use Problem
2018-12-26 Injury None Battery Problem
2018-12-25 Injury None Battery Problem
2018-12-21 Injury None Inappropriate/Inadequate Shock/Stimulation
2018-12-19 Injury None Adverse Event Without Identified Device or Use Problem
2018-12-19 Injury None Battery Problem
2018-12-18 Malfunction None Inappropriate or Unexpected Reset
2018-12-18 Malfunction None Fitting Problem
2018-12-17 Injury None Battery Problem
2018-12-13 Injury None Battery Problem
2018-12-11 Injury None Battery Problem
2018-12-10 Injury None Failure to Interrogate, Battery Problem, Inappropriate or Unexpected Reset, No Pacing
2018-12-07 Injury None Adverse Event Without Identified Device or Use Problem
2018-12-07 Injury None Adverse Event Without Identified Device or Use Problem
2018-12-07 Injury None Battery Problem
2018-12-06 Injury None Signal Artifact/Noise, Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2018-12-03 Injury None Battery Problem
2018-11-28 Malfunction None Failure to Interrogate
2018-11-27 Malfunction None Failure to Interrogate
2018-11-23 Injury None Battery Problem
2018-11-23 Injury None Battery Problem
2018-11-20 Injury None Battery Problem
2018-11-19 Injury None Battery Problem
2018-11-16 Injury None Inappropriate/Inadequate Shock/Stimulation, Delayed Charge Time
2018-11-16 Injury None Battery Problem
2018-11-14 Injury None Adverse Event Without Identified Device or Use Problem
2018-11-13 Injury None Battery Problem
2018-11-12 Injury None Adverse Event Without Identified Device or Use Problem
2018-11-12 Malfunction None Data Problem
2018-11-11 Injury None Battery Problem
2018-11-09 Injury None Battery Problem
2018-11-05 Injury None Adverse Event Without Identified Device or Use Problem
2018-11-05 Injury None Battery Problem
2018-10-31 Injury None Battery Problem
2018-10-30 Malfunction None Data Problem
2018-10-24 Injury None Inappropriate/Inadequate Shock/Stimulation, Under-Sensing
2018-10-22 Injury None Premature Discharge of Battery, Battery Problem
2018-10-22 Injury None Battery Problem
2018-10-17 Injury None Failure to Interrogate
2018-10-17 Injury None Battery Problem
2018-10-17 Injury None Premature Discharge of Battery, Battery Problem
2018-10-16 Injury None Battery Problem
2018-10-15 Injury None Premature Discharge of Battery
2018-10-12 Injury None Premature Discharge of Battery, Failure to Convert Rhythm
2018-10-12 Injury None Failure to Interrogate
2018-10-11 Injury None Battery Problem
2018-10-11 Injury None Premature Discharge of Battery, Failure to Interrogate
2018-10-10 Injury None Battery Problem
2018-10-07 Injury None Battery Problem
2018-10-04 Injury None Inappropriate/Inadequate Shock/Stimulation
2018-10-04 Injury None Adverse Event Without Identified Device or Use Problem
2018-10-04 Malfunction None Failure to Deliver Shock/Stimulation, Electromagnetic Interference, Over-Sensing
2018-10-03 Injury None Battery Problem
2018-10-01 Injury None Battery Problem
2018-09-30 Injury None Battery Problem
2018-09-28 Injury None Battery Problem
2018-09-25 Malfunction None Failure to Deliver Shock/Stimulation, Data Problem
2018-09-25 Injury None Battery Problem
2018-09-24 Malfunction None Failure to Interrogate
2018-09-23 Injury None Battery Problem
2018-09-20 Injury None Battery Problem
2018-09-19 Malfunction None Battery Problem
2018-09-19 Malfunction None Mechanical Problem
2018-09-19 Injury None Premature Discharge of Battery, Failure to Interrogate
2018-09-19 Injury None Adverse Event Without Identified Device or Use Problem
2018-09-18 Injury None Premature Discharge of Battery, Battery Problem
2018-09-17 Injury None Battery Problem
2018-09-16 Injury None Battery Problem
2018-09-15 Injury None Inappropriate/Inadequate Shock/Stimulation
2018-09-11 Injury None Adverse Event Without Identified Device or Use Problem
2018-09-11 Malfunction None Signal Artifact/Noise
2018-09-10 Injury None Adverse Event Without Identified Device or Use Problem
2018-09-10 Injury None Signal Artifact/Noise, Premature Discharge of Battery, Over-Sensing, Battery Problem
2018-09-09 Malfunction None Incorrect Interpretation of Signal
2018-09-05 Injury None Premature Discharge of Battery, Battery Problem
2018-09-05 Injury None Premature Discharge of Battery, Failure to Interrogate
2018-09-04 Injury None Premature Discharge of Battery
2018-09-04 Malfunction None Adverse Event Without Identified Device or Use Problem
2018-09-04 Injury None Battery Problem
2018-09-04 Injury None Over-Sensing, Incorrect Interpretation of Signal, Inappropriate/Inadequate Shock/Stimulation
2018-08-29 Injury None Adverse Event Without Identified Device or Use Problem
2018-08-28 Injury None Battery Problem
2018-08-27 Injury None Adverse Event Without Identified Device or Use Problem
2018-08-27 Malfunction None Adverse Event Without Identified Device or Use Problem
2018-08-26 Injury None Battery Problem
2018-08-24 Injury None Inappropriate/Inadequate Shock/Stimulation
2018-08-23 Injury None Battery Problem
2018-08-23 Malfunction None Battery Problem
2018-08-22 Injury None Electromagnetic Interference, Inappropriate or Unexpected Reset
2018-08-22 Injury None Application Program Version or Upgrade Problem, Inappropriate or Unexpected Reset
2018-08-18 Injury None Incorrect Interpretation of Signal
2018-08-18 Injury None Battery Problem
2018-08-17 Injury None Battery Problem
2018-08-17 Injury None Battery Problem
2018-08-10 Death None Adverse Event Without Identified Device or Use Problem
2018-08-10 Injury None Battery Problem
2018-08-09 Injury None Battery Problem
2018-08-08 Injury None Inappropriate/Inadequate Shock/Stimulation, Under-Sensing
2018-08-07 Injury None Incorrect Interpretation of Signal, Inappropriate/Inadequate Shock/Stimulation
2018-08-07 Injury None Incorrect Interpretation of Signal, Inappropriate/Inadequate Shock/Stimulation
2018-08-07 Injury None Battery Problem
2018-08-06 Injury None Premature Discharge of Battery, Battery Problem
2018-08-06 Injury None Adverse Event Without Identified Device or Use Problem
2018-08-06 Injury None Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2018-08-04 Injury None Incorrect Interpretation of Signal, Inappropriate/Inadequate Shock/Stimulation
2018-08-03 Injury None Battery Problem
2018-08-03 Injury None Signal Artifact/Noise
2018-08-02 Injury None Battery Problem
2018-08-01 Injury None Battery Problem
2018-07-30 Injury None Inappropriate/Inadequate Shock/Stimulation
2018-07-30 Injury None Adverse Event Without Identified Device or Use Problem
2018-07-30 Injury None Battery Problem
2018-07-28 Death None Adverse Event Without Identified Device or Use Problem
2018-07-26 Injury None Adverse Event Without Identified Device or Use Problem
2018-07-25 Injury None Battery Problem
2018-07-25 Injury None Failure to Deliver Shock/Stimulation, Inappropriate/Inadequate Shock/Stimulation, Output Problem
2018-07-25 Injury None Battery Problem
2018-07-25 Injury None Battery Problem
2018-07-25 Injury None Failure to Interrogate, Telemetry Discrepancy
2018-07-24 Injury None Signal Artifact/Noise, Over-Sensing
2018-07-24 Injury None Battery Problem
2018-07-22 Injury None Inappropriate/Inadequate Shock/Stimulation, Inappropriate or Unexpected Reset
2018-07-21 Injury None Battery Problem
2018-07-19 Injury None Premature Discharge of Battery, Failure to Interrogate
2018-07-18 Injury No Clinical Signs, Symptoms or Conditions Premature Discharge of Battery, Battery Problem
2018-07-18 Injury None Premature Discharge of Battery
2018-07-17 Injury None Incorrect Interpretation of Signal, Inappropriate/Inadequate Shock/Stimulation
2018-07-17 Malfunction None Adverse Event Without Identified Device or Use Problem
2018-07-17 Injury None Premature Discharge of Battery, Failure to Interrogate
2018-07-16 Malfunction None Failure to Interrogate
2018-07-13 Injury None Adverse Event Without Identified Device or Use Problem
2018-07-12 Injury None Battery Problem
2018-07-10 Malfunction Insufficient Information Nonstandard Device
2018-07-10 Malfunction Insufficient Information Nonstandard Device
2018-07-10 Injury None Battery Problem
2018-07-09 Injury None Adverse Event Without Identified Device or Use Problem
2018-07-07 Injury None Battery Problem
2018-07-06 Injury None Battery Problem
2018-07-06 Injury None Battery Problem
2018-07-05 Injury None Battery Problem
2018-07-03 Injury None Battery Problem
2018-07-02 Injury None Premature Discharge of Battery, Battery Problem
2018-07-02 Death None Failure to Deliver Shock/Stimulation
2018-06-30 Injury None Battery Problem
2018-06-30 Injury None Battery Problem
2018-06-30 Injury None Inappropriate/Inadequate Shock/Stimulation
2018-06-30 Injury None Premature Discharge of Battery, Inappropriate or Unexpected Reset
2018-06-29 Death None Adverse Event Without Identified Device or Use Problem
2018-06-29 Injury None Adverse Event Without Identified Device or Use Problem
2018-06-28 Injury None Battery Problem
2018-06-28 Injury None Battery Problem
2018-06-27 Injury None Battery Problem
2018-06-25 Injury None Battery Problem
2018-06-25 Injury None Adverse Event Without Identified Device or Use Problem
2018-06-24 Injury None Battery Problem
2018-06-20 Injury None Battery Problem
2018-06-19 Injury None Premature Discharge of Battery, Failure to Interrogate
2018-06-18 Injury None Battery Problem
2018-06-18 Injury None Battery Problem
2018-06-18 Injury None Battery Problem
2018-06-17 Injury None Premature Discharge of Battery, Battery Problem
2018-06-14 Injury None Battery Problem
2018-06-13 Injury None Inappropriate/Inadequate Shock/Stimulation
2018-06-07 Injury None Premature Discharge of Battery, Failure to Interrogate
2018-06-07 Injury None Incorrect Interpretation of Signal, Inappropriate/Inadequate Shock/Stimulation
2018-06-05 Injury None Premature Discharge of Battery
2018-06-05 Injury None Adverse Event Without Identified Device or Use Problem
2018-06-03 Injury None Battery Problem
2018-06-02 Injury None Inappropriate/Inadequate Shock/Stimulation
2018-05-31 Injury None Adverse Event Without Identified Device or Use Problem
2018-05-30 Injury None Battery Problem
2018-05-28 Injury None Premature Discharge of Battery, Battery Problem
2018-05-27 Injury None Incorrect Interpretation of Signal, Under-Sensing, Data Problem
2018-05-24 Malfunction None Premature Discharge of Battery, Battery Problem
2018-05-24 Injury None Adverse Event Without Identified Device or Use Problem
2018-05-23 Injury None Battery Problem
2018-05-21 Malfunction None Battery Problem
2018-05-19 Injury None Inappropriate/Inadequate Shock/Stimulation
2018-05-15 Malfunction None Over-Sensing
2018-05-13 Injury None Premature Discharge of Battery
2018-05-10 Injury None Premature Discharge of Battery
2018-05-08 Injury None Battery Problem
2018-05-08 Injury None Premature Discharge of Battery
2018-05-07 Injury None Battery Problem
2018-05-02 Injury None Battery Problem
2018-05-02 Malfunction None Failure to Interrogate
2018-05-02 Injury None Premature Discharge of Battery, Inappropriate/Inadequate Shock/Stimulation, Battery Problem
2018-05-01 Injury None Battery Problem
2018-05-01 Injury None Adverse Event Without Identified Device or Use Problem
2018-04-30 Injury None Premature Discharge of Battery, Battery Problem
2018-04-28 Injury None Battery Problem
2018-04-25 Injury None Premature Discharge of Battery, Failure to Interrogate, Battery Problem
2018-04-25 Injury None Incorrect Interpretation of Signal, Inappropriate/Inadequate Shock/Stimulation
2018-04-25 Injury None Battery Problem
2018-04-23 Malfunction None Battery Problem
2018-04-23 Injury None Battery Problem
2018-04-23 Injury None Battery Problem
2018-04-19 Injury None Failure to Interrogate, Wireless Communication Problem
2018-04-19 Injury None Premature Discharge of Battery, Battery Problem, Inappropriate or Unexpected Reset
2018-04-19 Injury None Battery Problem
2018-04-18 Malfunction None Battery Problem
2018-04-16 Injury None Premature Discharge of Battery, Failure to Interrogate
2018-04-15 Injury None Battery Problem
2018-04-14 Injury None Battery Problem
2018-04-13 Injury None Adverse Event Without Identified Device or Use Problem
2018-04-09 Injury None Failure to Interrogate
2018-04-06 Injury None Adverse Event Without Identified Device or Use Problem
2018-04-03 Injury None Adverse Event Without Identified Device or Use Problem
2018-04-02 Malfunction None Adverse Event Without Identified Device or Use Problem
2018-03-31 Malfunction None Adverse Event Without Identified Device or Use Problem
2018-03-30 Injury None Premature Discharge of Battery, Failure to Interrogate
2018-03-29 Injury None Adverse Event Without Identified Device or Use Problem
2018-03-28 Injury None Adverse Event Without Identified Device or Use Problem
2018-03-28 Injury None Failure to Interrogate
2018-03-27 Injury None Battery Problem
2018-03-27 Injury None Battery Problem
2018-03-27 Injury None Premature Discharge of Battery
2018-03-26 Injury None Adverse Event Without Identified Device or Use Problem
2018-03-25 Injury None Battery Problem
2018-03-22 Injury None Adverse Event Without Identified Device or Use Problem
2018-03-21 Injury None Over-Sensing, Incorrect Interpretation of Signal
2018-03-21 Injury None Failure to Interrogate
2018-03-20 Injury None Signal Artifact/Noise, Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2018-03-20 Injury None Battery Problem
2018-03-19 Injury None Battery Problem
2018-03-19 Injury None Battery Problem
2018-03-18 Injury None Battery Problem
2018-03-16 Injury None Battery Problem
2018-03-16 Injury None Signal Artifact/Noise, Inappropriate/Inadequate Shock/Stimulation
2018-03-15 Malfunction None Battery Problem
2018-03-15 Malfunction None Over-Sensing
2018-03-14 Malfunction None Over-Sensing
2018-03-13 Injury None Adverse Event Without Identified Device or Use Problem
2018-03-11 Injury None Battery Problem
2018-03-08 Injury None Adverse Event Without Identified Device or Use Problem
2018-03-07 Injury None Premature Discharge of Battery, Failure to Interrogate
2018-03-06 Injury None Premature Discharge of Battery
2018-03-05 Death None Adverse Event Without Identified Device or Use Problem
2018-03-04 Injury None Battery Problem
2018-03-02 Injury None Premature Discharge of Battery, Battery Problem
2018-03-01 Injury None Battery Problem
2018-03-01 Injury None Adverse Event Without Identified Device or Use Problem
2018-03-01 Injury None Inappropriate/Inadequate Shock/Stimulation
2018-02-27 Malfunction None Intermittent Capture, Failure to Capture
2018-02-27 Injury None Battery Problem
2018-02-25 Injury None Battery Problem
2018-02-22 Injury None Adverse Event Without Identified Device or Use Problem
2018-02-22 Injury None Adverse Event Without Identified Device or Use Problem
2018-02-21 Injury None Battery Problem
2018-02-20 Injury None Inappropriate/Inadequate Shock/Stimulation, Delayed Charge Time
2018-02-20 Injury None Defibrillation/Stimulation Problem, Under-Sensing
2018-02-19 Injury None Battery Problem
2018-02-19 Injury None Battery Problem
2018-02-18 Injury None Battery Problem
2018-02-18 Injury None Battery Problem
2018-02-14 Injury None Battery Problem
2018-02-14 Injury None Battery Problem
2018-02-09 Injury None Adverse Event Without Identified Device or Use Problem
2018-02-09 Injury None Adverse Event Without Identified Device or Use Problem
2018-02-08 Injury None Adverse Event Without Identified Device or Use Problem
2018-02-04 Injury None Inappropriate or Unexpected Reset, Output Problem
2018-02-01 Injury None Battery Problem
2018-02-01 Injury None Battery Problem
2018-01-31 Injury None Premature Discharge of Battery, Battery Problem
2018-01-31 Injury None Premature Discharge of Battery, Difficult to Interrogate
2018-01-31 Injury None Device Operates Differently Than Expected
2018-01-30 Malfunction None Computer Software Problem
2018-01-30 Injury None Adverse Event Without Identified Device or Use Problem
2018-01-29 Malfunction None Battery Problem
2018-01-28 Injury None Battery Problem
2018-01-25 Injury None Battery Problem
2018-01-23 Injury None Adverse Event Without Identified Device or Use Problem
2018-01-22 Injury None Battery Problem
2018-01-22 Injury None Inappropriate/Inadequate Shock/Stimulation
2018-01-21 Injury None Premature Discharge of Battery, Battery Problem
2018-01-19 Malfunction None Output Problem
2018-01-19 Injury None Adverse Event Without Identified Device or Use Problem
2018-01-19 Malfunction None Delayed Charge Time
2018-01-12 Injury None Premature Discharge of Battery, Inappropriate or Unexpected Reset
2018-01-11 Injury None Battery Problem
2018-01-11 Injury None Battery Problem
2018-01-11 Injury None Battery Problem
2018-01-10 Injury None Battery Problem
2018-01-10 Injury None Inappropriate or Unexpected Reset
2018-01-09 Injury None Battery Problem
2018-01-08 Injury None Battery Problem
2018-01-04 Malfunction None Adverse Event Without Identified Device or Use Problem
2018-01-02 Injury None Battery Problem
2018-01-02 Injury None Battery Problem
2017-12-29 Injury None Adverse Event Without Identified Device or Use Problem
2017-12-28 Death None Adverse Event Without Identified Device or Use Problem
2017-12-27 Injury None Battery Problem
2017-12-25 Death None Output Problem
2017-12-24 Malfunction None Telemetry Discrepancy
2017-12-23 Injury None Battery Problem
2017-12-23 Injury None Battery Problem
2017-12-21 Injury None Battery Problem
2017-12-20 Injury None Inappropriate/Inadequate Shock/Stimulation
2017-12-20 Injury None Adverse Event Without Identified Device or Use Problem
2017-12-20 Malfunction None Connection Problem
2017-12-18 Injury None Battery Problem
2017-12-17 Injury None Battery Problem
2017-12-17 Injury None Battery Problem
2017-12-17 Injury None Battery Problem
2017-12-14 Injury None Adverse Event Without Identified Device or Use Problem
2017-12-14 Injury None Battery Problem
2017-12-13 Injury None Battery Problem
2017-12-13 Malfunction None Delayed Charge Time
2017-12-13 Injury None Adverse Event Without Identified Device or Use Problem
2017-12-13 Malfunction None Adverse Event Without Identified Device or Use Problem
2017-12-12 Injury None Adverse Event Without Identified Device or Use Problem
2017-12-12 Injury None Battery Problem
2017-12-12 Injury None Battery Problem
2017-12-11 Injury None Battery Problem
2017-12-10 Injury None Battery Problem
2017-12-06 Injury None Battery Problem
2017-12-06 Injury None Adverse Event Without Identified Device or Use Problem
2017-12-04 Injury None Adverse Event Without Identified Device or Use Problem
2017-12-02 Injury None Battery Problem
2017-12-02 Injury None Failure to Interrogate
2017-12-01 Injury None Adverse Event Without Identified Device or Use Problem
2017-12-01 Injury None Battery Problem
2017-11-30 Injury None Adverse Event Without Identified Device or Use Problem
2017-11-30 Injury None Battery Problem
2017-11-29 Injury None Battery Problem
2017-11-28 Injury None Battery Problem
2017-11-27 Injury None Adverse Event Without Identified Device or Use Problem
2017-11-22 Injury None Failure to Interrogate
2017-11-22 Injury None Battery Problem
2017-11-22 Injury None Battery Problem
2017-11-22 Injury None Adverse Event Without Identified Device or Use Problem
2017-11-18 Injury None Battery Problem
2017-11-18 Injury None Battery Problem
2017-11-17 Injury None Adverse Event Without Identified Device or Use Problem
2017-11-16 Death None Adverse Event Without Identified Device or Use Problem
2017-11-16 Injury None Battery Problem
2017-11-16 Injury None Adverse Event Without Identified Device or Use Problem
2017-11-15 Injury None Premature Discharge of Battery
2017-11-13 Injury None Failure to Interrogate
2017-11-12 Injury None Battery Problem
2017-11-10 Injury None Device Alarm System
2017-11-09 Injury None Adverse Event Without Identified Device or Use Problem
2017-11-09 Injury None Telemetry Discrepancy, Battery Problem
2017-11-08 Injury None Battery Problem
2017-11-08 Injury None Premature Discharge of Battery
2017-11-03 Injury None Adverse Event Without Identified Device or Use Problem
2017-11-03 Injury None Premature Discharge of Battery
2017-11-03 Injury None Adverse Event Without Identified Device or Use Problem
2017-11-02 Injury None Premature Discharge of Battery, Battery Problem
2017-11-02 Malfunction None Output Problem
2017-11-02 Injury None Battery Problem
2017-11-02 Injury None Premature Discharge of Battery, Battery Problem
2017-11-01 Injury None Battery Problem
2017-10-31 Malfunction None Failure to Interrogate
2017-10-31 Injury None Device Operates Differently Than Expected
2017-10-30 Injury None Battery Problem
2017-10-28 Injury None Adverse Event Without Identified Device or Use Problem
2017-10-27 Malfunction None Under-Sensing
2017-10-27 Injury None Battery Problem
2017-10-26 Injury None Battery Problem
2017-10-26 Injury None Adverse Event Without Identified Device or Use Problem
2017-10-26 Injury None Battery Problem
2017-10-26 Injury None Battery Problem
2017-10-24 Injury None Adverse Event Without Identified Device or Use Problem
2017-10-24 Injury None Battery Problem
2017-10-24 Injury None Adverse Event Without Identified Device or Use Problem
2017-10-23 Injury None Adverse Event Without Identified Device or Use Problem
2017-10-20 Injury None Battery Problem
2017-10-17 Injury None Adverse Event Without Identified Device or Use Problem
2017-10-17 Malfunction Insufficient Information Nonstandard Device
2017-10-16 Injury None Battery Problem
2017-10-16 Injury None Battery Problem
2017-10-16 Injury None Battery Problem
2017-10-14 Malfunction None Under-Sensing, Output Problem
2017-10-13 Injury None Premature Discharge of Battery, Failure to Interrogate, Telemetry Discrepancy
2017-10-13 Malfunction None Device Operates Differently Than Expected
2017-10-13 Injury None Battery Problem
2017-10-11 Injury None Premature Discharge of Battery, Failure to Interrogate
2017-10-10 Injury None Battery Problem
2017-10-09 Injury None Battery Problem
2017-10-07 Injury None Premature Discharge of Battery, Battery Problem
2017-10-07 Injury None Battery Problem
2017-10-06 Injury None Battery Problem
2017-10-04 Injury None Battery Problem
2017-10-04 Injury None Battery Problem
2017-10-02 Injury None Battery Problem
2017-10-02 Injury None Adverse Event Without Identified Device or Use Problem
2017-10-01 Malfunction None High impedance
2017-09-29 Injury None Inappropriate/Inadequate Shock/Stimulation
2017-09-29 Malfunction None Failure to Interrogate, Battery Problem
2017-09-29 Injury None Battery Problem
2017-09-28 Injury None Battery Problem
2017-09-28 Injury None Battery Problem
2017-09-28 Injury None Adverse Event Without Identified Device or Use Problem
2017-09-28 Injury None Inappropriate/Inadequate Shock/Stimulation
2017-09-27 Injury None Battery Problem
2017-09-27 Injury None Adverse Event Without Identified Device or Use Problem
2017-09-27 Injury None Battery Problem
2017-09-26 Injury None Adverse Event Without Identified Device or Use Problem
2017-09-26 Injury None Over-Sensing, Inappropriate/Inadequate Shock/Stimulation, Decreased Sensitivity
2017-09-25 Injury None Battery Problem
2017-09-25 Injury None Battery Problem
2017-09-24 Injury None Battery Problem
2017-09-24 Injury None Battery Problem
2017-09-23 Injury None Incorrect Interpretation of Signal
2017-09-22 Injury None Battery Problem
2017-09-22 Injury None Battery Problem
2017-09-21 Injury None Device Alarm System, Premature Discharge of Battery, Battery Problem
2017-09-21 Malfunction None Adverse Event Without Identified Device or Use Problem
2017-09-20 Injury None Battery Problem
2017-09-20 Injury None Battery Problem
2017-09-19 Injury None Battery Problem
2017-09-19 Injury None Battery Problem
2017-09-18 Injury None Battery Problem
2017-09-18 Injury None Battery Problem
2017-09-18 Injury None Battery Problem
2017-09-17 Injury None Battery Problem
2017-09-16 Injury None Inappropriate/Inadequate Shock/Stimulation
2017-09-15 Injury None Adverse Event Without Identified Device or Use Problem
2017-09-15 Injury None Battery Problem
2017-09-15 Injury None Battery Problem
2017-09-15 Injury None Premature Discharge of Battery, Battery Problem
2017-09-14 Injury None Battery Problem
2017-09-13 Injury None Battery Problem
2017-09-13 Injury None Battery Problem
2017-09-13 Injury None Inappropriate/Inadequate Shock/Stimulation, Programming Issue
2017-09-13 Injury None Battery Problem
2017-09-12 Injury None Adverse Event Without Identified Device or Use Problem
2017-09-12 Injury None Battery Problem
2017-09-12 Injury None Battery Problem
2017-09-12 Injury None Battery Problem
2017-09-12 Injury None Battery Problem
2017-09-12 Injury None Battery Problem
2017-09-11 Injury None Battery Problem
2017-09-11 Injury None Battery Problem
2017-09-11 Injury None Battery Problem
2017-09-11 Injury None Battery Problem
2017-09-11 Injury None Battery Problem
2017-09-10 Injury None Battery Problem
2017-09-10 Injury None Inappropriate/Inadequate Shock/Stimulation
2017-09-10 Injury None Battery Problem
2017-09-10 Malfunction None Battery Problem
2017-09-10 Injury None Battery Problem
2017-09-10 Injury None Battery Problem
2017-09-10 Injury None Battery Problem
2017-09-09 Injury None Battery Problem
2017-09-09 Injury None Battery Problem
2017-09-08 Injury None Battery Problem
2017-09-08 Injury None Battery Problem
2017-09-08 Injury None Battery Problem
2017-09-08 Injury None Battery Problem
2017-09-08 Injury None Battery Problem
2017-09-07 Injury None Battery Problem
2017-09-07 Injury None Battery Problem
2017-09-07 Injury None Battery Problem
2017-09-07 Injury None Battery Problem
2017-09-07 Injury None Battery Problem
2017-09-07 Injury None Battery Problem
2017-09-07 Injury None Battery Problem
2017-09-07 Injury None Battery Problem
2017-09-06 Injury None Battery Problem
2017-09-06 Injury None Battery Problem
2017-09-06 Injury None Battery Problem
2017-09-06 Injury None Adverse Event Without Identified Device or Use Problem
2017-09-06 Injury None Battery Problem
2017-09-06 Injury None Battery Problem
2017-09-06 Injury None Battery Problem
2017-09-05 Injury None Battery Problem
2017-09-05 Injury None Battery Problem
2017-09-05 Injury None Failure to Capture
2017-09-05 Injury None Battery Problem
2017-09-05 Injury None Battery Problem
2017-09-02 Injury None Battery Problem
2017-09-01 Injury None Battery Problem
2017-09-01 Injury None Adverse Event Without Identified Device or Use Problem
2017-09-01 Injury None Battery Problem
2017-09-01 Injury None Battery Problem
2017-09-01 Injury None Adverse Event Without Identified Device or Use Problem
2017-09-01 Injury None Battery Problem
2017-08-31 Injury None Adverse Event Without Identified Device or Use Problem
2017-08-31 Injury None Battery Problem
2017-08-30 Injury None Battery Problem
2017-08-30 Injury None Adverse Event Without Identified Device or Use Problem
2017-08-28 Injury None Battery Problem
2017-08-28 Malfunction None Signal Artifact/Noise
2017-08-26 Injury None Battery Problem
2017-08-25 Injury None Adverse Event Without Identified Device or Use Problem
2017-08-24 Injury None Adverse Event Without Identified Device or Use Problem
2017-08-22 Injury None Premature Discharge of Battery, Premature Elective Replacement Indicator, Inappropriate or Unexpected Reset
2017-08-22 Injury None Premature Discharge of Battery
2017-08-20 Injury None Battery Problem
2017-08-17 Malfunction None Device Operates Differently Than Expected
2017-08-17 Injury None Adverse Event Without Identified Device or Use Problem
2017-08-16 Injury None Inappropriate/Inadequate Shock/Stimulation
2017-08-16 Injury None Inappropriate/Inadequate Shock/Stimulation, Under-Sensing
2017-08-15 Injury None Premature Discharge of Battery, Failure to Interrogate
2017-08-15 Injury None Inappropriate/Inadequate Shock/Stimulation
2017-08-14 Injury None Adverse Event Without Identified Device or Use Problem
2017-08-10 Injury None Telemetry Discrepancy
2017-08-10 Injury None Premature Discharge of Battery
2017-08-09 Injury None Adverse Event Without Identified Device or Use Problem
2017-08-09 Injury None Premature Discharge of Battery
2017-08-08 Injury None Battery Problem
2017-08-07 Injury None Adverse Event Without Identified Device or Use Problem
2017-08-07 Malfunction None Premature Discharge of Battery, Battery Problem
2017-08-03 Injury None Adverse Event Without Identified Device or Use Problem
2017-08-03 Death None Adverse Event Without Identified Device or Use Problem
2017-08-01 Injury None Premature Discharge of Battery, Failure to Interrogate
2017-08-01 Injury None Premature Elective Replacement Indicator
2017-07-31 Injury None Adverse Event Without Identified Device or Use Problem
2017-07-31 Injury None Premature Discharge of Battery
2017-07-23 Malfunction None Signal Artifact/Noise, Over-Sensing
2017-07-22 Injury None Battery Problem
2017-07-21 Injury None Adverse Event Without Identified Device or Use Problem
2017-07-17 Injury None Adverse Event Without Identified Device or Use Problem
2017-07-17 Malfunction None Over-Sensing
2017-07-15 Injury None Premature Discharge of Battery
2017-07-14 Injury None Adverse Event Without Identified Device or Use Problem
2017-07-13 Injury None Premature Elective Replacement Indicator
2017-07-13 Injury None Premature Discharge of Battery, Telemetry Discrepancy
2017-07-12 Injury None Adverse Event Without Identified Device or Use Problem
2017-07-11 Injury None Adverse Event Without Identified Device or Use Problem
2017-07-06 Death None Adverse Event Without Identified Device or Use Problem
2017-07-06 Malfunction None Failure to Interrogate
2017-07-05 Injury None Adverse Event Without Identified Device or Use Problem
2017-07-05 Injury None Adverse Event Without Identified Device or Use Problem
2017-07-04 Injury None Premature Discharge of Battery
2017-06-28 Injury None Adverse Event Without Identified Device or Use Problem
2017-06-28 Injury None Inappropriate/Inadequate Shock/Stimulation
2017-06-27 Malfunction None Device Operates Differently Than Expected
2017-06-27 Injury None Premature Discharge of Battery, Battery Problem
2017-06-27 Injury None Premature Discharge of Battery, Adverse Event Without Identified Device or Use Problem
2017-06-26 Injury None Premature Discharge of Battery, Difficult to Interrogate
2017-06-26 Malfunction None High impedance
2017-06-26 Injury None Adverse Event Without Identified Device or Use Problem
2017-06-21 Injury None Adverse Event Without Identified Device or Use Problem
2017-06-20 Malfunction Insufficient Information Nonstandard Device
2017-06-19 Injury None Adverse Event Without Identified Device or Use Problem
2017-06-19 Injury None Adverse Event Without Identified Device or Use Problem
2017-06-17 Injury None Premature Discharge of Battery, Failure to Interrogate, Premature Elective Replacement Indicator
2017-06-14 Injury None Delayed Charge Time
2017-06-14 Injury None Failure to Interrogate
2017-06-13 Malfunction None Premature Discharge of Battery
2017-06-11 Malfunction None Over-Sensing
2017-06-10 Injury None Adverse Event Without Identified Device or Use Problem
2017-06-09 Injury None Adverse Event Without Identified Device or Use Problem
2017-06-09 Injury None Adverse Event Without Identified Device or Use Problem
2017-06-07 Injury None Inappropriate/Inadequate Shock/Stimulation
2017-06-07 Injury None Failure to Interrogate, Telemetry Discrepancy
2017-06-01 Injury None Adverse Event Without Identified Device or Use Problem
2017-06-01 Injury None Adverse Event Without Identified Device or Use Problem
2017-06-01 Injury None Premature Discharge of Battery, Failure to Interrogate
2017-05-30 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-29 Death None Adverse Event Without Identified Device or Use Problem
2017-05-27 Death None Adverse Event Without Identified Device or Use Problem
2017-05-25 Injury None Premature Discharge of Battery, Premature Elective Replacement Indicator
2017-05-25 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-24 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-24 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-23 Injury None Premature Discharge of Battery, Failure to Interrogate, Telemetry Discrepancy
2017-05-22 Injury None Premature Discharge of Battery
2017-05-22 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-19 Injury None Pacing Problem, Communication or Transmission Problem
2017-05-17 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-16 Injury None Premature Discharge of Battery, Failure to Interrogate, Pacing Problem, Deformation Due to Compressive Stress
2017-05-16 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-15 Injury None Premature Discharge of Battery, Failure to Interrogate
2017-05-15 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-14 Malfunction None Defibrillation/Stimulation Problem, Programming Issue
2017-05-12 Injury None Inappropriate/Inadequate Shock/Stimulation
2017-05-10 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-10 Injury None Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2017-05-09 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-08 Malfunction None Inappropriate/Inadequate Shock/Stimulation
2017-05-08 Injury None Premature Discharge of Battery, Break, Failure to Interrogate, Premature Elective Replacement Indicator
2017-05-08 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-05 Injury None Premature Discharge of Battery
2017-05-05 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-04 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-04 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-03 Injury None Premature Discharge of Battery, Failure to Interrogate
2017-05-03 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-03 Death None Adverse Event Without Identified Device or Use Problem
2017-05-03 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-02 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-02 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-01 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-01 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-01 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-01 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-28 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-27 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-27 Injury None Premature Discharge of Battery, Failure to Interrogate
2017-04-27 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-27 Injury None Failure to Interrogate
2017-04-26 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-25 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-25 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-25 Injury None Inappropriate/Inadequate Shock/Stimulation, Adverse Event Without Identified Device or Use Problem
2017-04-24 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-21 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-21 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-21 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-20 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-19 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-19 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-18 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-18 Malfunction None Over-Sensing
2017-04-18 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-18 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-17 Injury None Premature Discharge of Battery, Failure to Interrogate
2017-04-15 Death None Adverse Event Without Identified Device or Use Problem
2017-04-14 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-14 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-14 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-12 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-12 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-11 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-11 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-11 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-11 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-11 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-10 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-10 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-10 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-10 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-10 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-10 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-10 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-10 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-10 Death None Adverse Event Without Identified Device or Use Problem
2017-04-10 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-10 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-10 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-10 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-10 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-10 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-07 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-07 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-07 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-07 Injury None Over-Sensing, Pacemaker Found in Back-Up Mode, Telemetry Discrepancy
2017-04-06 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-06 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-06 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-06 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-05 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-05 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-05 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-05 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-05 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-05 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-05 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-05 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-05 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-05 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-05 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-04 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-04 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-04 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-04 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-03 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-03 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-03 Malfunction Insufficient Information Nonstandard Device
2017-04-03 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-03 Malfunction None Adverse Event Without Identified Device or Use Problem
2017-04-03 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-03 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-03 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-01 Injury None Inappropriate/Inadequate Shock/Stimulation
2017-03-31 Malfunction None Failure to Capture, Device Operates Differently Than Expected
2017-03-31 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-30 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-30 Injury None Inappropriate/Inadequate Shock/Stimulation
2017-03-29 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-29 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-29 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-29 Injury None Premature Discharge of Battery
2017-03-29 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-29 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-28 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-28 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-28 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-27 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-27 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-27 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-27 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-27 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-26 Injury None Inappropriate/Inadequate Shock/Stimulation
2017-03-26 Injury None Inappropriate/Inadequate Shock/Stimulation
2017-03-24 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-24 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-24 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-24 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-24 Injury None Premature Discharge of Battery, Failure to Interrogate
2017-03-24 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-24 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-24 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-23 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-23 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-23 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-23 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-22 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-22 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-22 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-22 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-22 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-21 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-21 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-21 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-21 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-21 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-21 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-20 Injury None Premature Discharge of Battery
2017-03-20 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-20 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-20 Injury None Premature Elective Replacement Indicator
2017-03-20 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-17 Injury None Premature Discharge of Battery
2017-03-17 Injury None Premature Discharge of Battery, Failure to Interrogate, Adverse Event Without Identified Device or Use Problem
2017-03-17 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-17 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-17 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-16 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-16 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-16 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-16 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-16 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-15 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-15 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-14 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-14 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-14 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-13 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-13 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-13 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-13 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-13 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-10 Malfunction None Nonstandard Device, Adverse Event Without Identified Device or Use Problem
2017-03-10 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-10 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-09 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-08 Injury None Premature Discharge of Battery, Failure to Interrogate
2017-03-08 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-08 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-07 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-07 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-07 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-07 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-07 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-07 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-07 Injury None Premature Discharge of Battery
2017-03-07 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-07 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-06 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-06 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-03 Malfunction None Over-Sensing
2017-03-03 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-02 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-02 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-02 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-02 Injury None Inappropriate or Unexpected Reset
2017-03-02 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-01 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-01 Malfunction None High impedance
2017-03-01 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-01 Injury None Over-Sensing, Inappropriate/Inadequate Shock/Stimulation, Under-Sensing
2017-02-28 Malfunction None Pacing Problem
2017-02-28 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-28 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-28 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-27 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-27 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-27 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-25 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-24 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-24 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-24 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-23 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-23 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-23 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-23 Injury None Failure to Interrogate, Premature Elective Replacement Indicator
2017-02-23 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-23 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-23 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-22 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-22 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-22 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-22 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-22 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-21 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-21 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-21 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-21 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-21 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-21 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-21 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-20 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-20 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-20 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-20 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-20 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-20 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-17 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-17 Injury None Premature Discharge of Battery
2017-02-17 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-17 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-17 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-16 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-16 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-15 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-15 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-15 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-15 Injury None Premature Discharge of Battery
2017-02-14 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-14 Injury None Inappropriate/Inadequate Shock/Stimulation
2017-02-14 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-14 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-13 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-13 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-13 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-10 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-10 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-10 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-10 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-10 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-10 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-09 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-09 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-09 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-09 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-08 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-08 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-08 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-08 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-08 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-07 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-07 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-07 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-07 Injury None Premature Discharge of Battery
2017-02-07 Malfunction None Pacing Problem, Defibrillation/Stimulation Problem, Device Operates Differently Than Expected
2017-02-06 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-06 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-06 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-06 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-06 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-06 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-06 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-06 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-06 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-04 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-03 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-03 Injury None Premature Discharge of Battery
2017-02-03 Malfunction None Over-Sensing, Device Operates Differently Than Expected
2017-02-03 Death None Adverse Event Without Identified Device or Use Problem
2017-02-03 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-02 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-02 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-02 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-02 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-02 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-02 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-02 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-02 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-02 Malfunction None Delayed Charge Time
2017-02-01 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-01 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-01 Injury None Failure to Interrogate
2017-02-01 Injury None Failure to Interrogate, Wireless Communication Problem
2017-02-01 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-31 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-31 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-31 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-31 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-31 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-31 Malfunction None Device Operates Differently Than Expected
2017-01-31 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-31 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-31 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-31 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-30 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-30 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-27 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-27 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-26 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-26 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-26 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-26 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-25 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-25 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-25 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-25 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-25 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-24 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-24 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-24 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-24 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-24 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-24 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-23 Injury None Premature Discharge of Battery
2017-01-23 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-23 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-23 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-23 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-23 Injury None Inappropriate/Inadequate Shock/Stimulation
2017-01-23 Injury None Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2017-01-23 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-23 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-22 Death None Adverse Event Without Identified Device or Use Problem
2017-01-20 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-20 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-20 Malfunction None High impedance
2017-01-19 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-19 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-19 Injury None Failure to Interrogate
2017-01-19 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-19 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-19 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-19 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-18 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-18 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-18 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-18 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-18 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-18 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-18 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-18 Malfunction None Programming Issue
2017-01-18 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-18 Death None Adverse Event Without Identified Device or Use Problem
2017-01-18 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-18 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-17 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-17 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-17 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-17 Injury None Inappropriate/Inadequate Shock/Stimulation
2017-01-17 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-16 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-16 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-16 Injury None Inappropriate/Inadequate Shock/Stimulation
2017-01-16 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-16 Injury None Premature Discharge of Battery
2017-01-14 Malfunction None Inappropriate or Unexpected Reset
2017-01-13 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-13 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-13 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-13 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-13 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-13 Malfunction None Vibration
2017-01-13 Injury None Inappropriate/Inadequate Shock/Stimulation
2017-01-13 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-12 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-12 Malfunction Insufficient Information Signal Artifact/Noise, Nonstandard Device, Over-Sensing
2017-01-12 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-12 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-12 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-12 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-11 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-11 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-11 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-11 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-11 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-11 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-11 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-10 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-10 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-10 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-10 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-10 Injury None Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2017-01-10 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-10 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-10 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-09 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-09 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-09 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-09 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-09 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-09 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-09 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-09 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-09 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-09 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-09 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-06 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-06 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-06 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-06 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-06 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-05 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-05 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-05 Injury None Premature Elective Replacement Indicator
2017-01-05 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-05 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-04 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-04 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-04 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-04 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-04 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-04 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-04 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-04 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-04 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-04 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-03 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-03 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-03 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-03 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-03 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-02 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-02 Malfunction None Inappropriate or Unexpected Reset
2017-01-02 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-30 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-30 Injury None Premature Elective Replacement Indicator
2016-12-30 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-30 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-29 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-29 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-29 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-29 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-29 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-29 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-29 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-29 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-29 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-29 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-29 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-29 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-28 Injury None Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2016-12-28 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-28 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-28 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-28 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-28 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-27 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-27 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-27 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-27 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-23 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-23 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-23 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-23 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-23 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-22 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-22 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-22 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-22 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-22 Injury None Premature Discharge of Battery, Adverse Event Without Identified Device or Use Problem
2016-12-22 Malfunction None Inappropriate or Unexpected Reset
2016-12-22 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-22 Injury None Premature Elective Replacement Indicator
2016-12-21 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-21 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-21 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-20 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-20 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-20 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-20 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-19 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-19 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-19 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-19 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-19 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-19 Injury None Premature Discharge of Battery, Premature Elective Replacement Indicator, Inappropriate/Inadequate Shock/Stimulation
2016-12-19 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-19 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-19 Injury None Premature Discharge of Battery
2016-12-18 Injury None Premature Discharge of Battery, Premature End-of-Life Indicator, Premature Elective Replacement Indicator
2016-12-16 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-16 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-16 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-16 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-16 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-16 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-16 Injury None Delayed Charge Time
2016-12-16 Death None Adverse Event Without Identified Device or Use Problem
2016-12-15 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-15 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-15 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-15 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-15 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-15 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-15 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-15 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-15 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-15 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-15 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-15 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-15 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-15 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-15 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-15 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-14 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-14 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-14 Injury None Failure to Interrogate, Vibration
2016-12-14 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-14 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-14 Injury None High impedance
2016-12-14 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-14 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-13 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-13 Malfunction None Device Operates Differently Than Expected
2016-12-13 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-13 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-13 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-13 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-13 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-13 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-13 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-13 Malfunction None Vibration
2016-12-13 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-12 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-12 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-12 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-12 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-12 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-12 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-12 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-12 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-12 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-11 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-10 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-10 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-10 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-09 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-09 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-09 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-09 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-09 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-09 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-09 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-09 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-09 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-09 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-09 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-09 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-09 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-09 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-09 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-08 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-08 Malfunction None Delayed Charge Time
2016-12-08 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-08 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-08 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-08 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-08 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-07 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-07 Injury None Inappropriate/Inadequate Shock/Stimulation
2016-12-07 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-07 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-07 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-07 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-07 Injury None Failure to Interrogate
2016-12-07 Injury None Vibration
2016-12-07 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-07 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-07 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-07 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-07 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-07 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-06 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-06 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-06 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-06 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-06 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-06 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-06 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-06 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-06 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-05 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-05 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-05 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-05 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-05 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-05 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-05 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-05 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-05 Injury No Clinical Signs, Symptoms or Conditions Adverse Event Without Identified Device or Use Problem
2016-12-05 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-05 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-05 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-05 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-05 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-04 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-03 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-02 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-02 Injury None Failure to Interrogate
2016-12-02 Injury None Failure to Interrogate, Premature Elective Replacement Indicator
2016-12-02 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-02 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-02 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-01 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-01 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-01 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-01 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-01 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-01 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-01 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-30 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-30 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-30 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-30 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-30 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-30 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-30 Injury None Premature Discharge of Battery, Adverse Event Without Identified Device or Use Problem
2016-11-30 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-30 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-30 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-29 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-29 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-29 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-29 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-29 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-29 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-29 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-29 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-29 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-29 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-29 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-29 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-29 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-29 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-29 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-29 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-29 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-29 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-28 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-28 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-28 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-28 Injury None Premature Discharge of Battery, Premature Elective Replacement Indicator
2016-11-28 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-28 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-28 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-28 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-28 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-28 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-28 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-28 Injury None Premature Discharge of Battery
2016-11-28 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-28 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-28 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-25 Injury None Inappropriate/Inadequate Shock/Stimulation
2016-11-25 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-25 Malfunction None Premature Discharge of Battery, Vibration
2016-11-25 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-24 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-23 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-23 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-23 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-23 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-23 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-23 Malfunction None Premature Discharge of Battery, Adverse Event Without Identified Device or Use Problem
2016-11-23 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-23 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-22 Death None Adverse Event Without Identified Device or Use Problem
2016-11-22 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-22 Injury None Signal Artifact/Noise, Inappropriate/Inadequate Shock/Stimulation
2016-11-22 Injury None Premature Discharge of Battery, Premature Elective Replacement Indicator
2016-11-22 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-22 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-22 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-22 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-22 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-22 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-22 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-21 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-21 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-21 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-21 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-21 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-21 Injury None High impedance, Over-Sensing, Inappropriate or Unexpected Reset
2016-11-21 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-21 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-21 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-20 Injury None Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2016-11-18 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-18 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-18 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-18 Injury None Premature Discharge of Battery
2016-11-18 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-18 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-18 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-18 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-18 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-18 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-18 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-17 Malfunction None Over-Sensing
2016-11-17 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-17 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-17 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-17 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-17 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-17 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-17 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-17 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-17 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-17 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-17 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-17 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-17 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-16 Injury None Failure to Interrogate
2016-11-16 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-16 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-16 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-16 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-16 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-16 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-16 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-16 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-16 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-16 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-16 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-16 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-16 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-15 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-15 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-15 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-15 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-15 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-15 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-15 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-15 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-15 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-15 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-14 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-14 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-14 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-14 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-14 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-14 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-14 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-14 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-14 Malfunction None Under-Sensing
2016-11-14 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-12 Injury None Inappropriate or Unexpected Reset
2016-11-11 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-11 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-11 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-11 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-11 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-11 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-11 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-11 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-11 Injury None Premature Discharge of Battery, Premature Elective Replacement Indicator
2016-11-11 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-11 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-11 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-11 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-10 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-10 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-10 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-10 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-10 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-10 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-10 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-10 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-10 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-10 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-09 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-09 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-09 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-09 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-09 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-09 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-09 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-08 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-08 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-08 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-08 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-08 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-08 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-08 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-08 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-07 Injury None Premature Elective Replacement Indicator
2016-11-07 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-07 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-07 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-07 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-07 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-07 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-07 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-07 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-07 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-07 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-07 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-07 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-07 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-07 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-07 Injury None Premature Discharge of Battery, Difficult to Interrogate
2016-11-07 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-07 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-07 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-07 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-06 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-06 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-05 Injury None Inappropriate/Inadequate Shock/Stimulation
2016-11-05 Death None Adverse Event Without Identified Device or Use Problem
2016-11-04 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-04 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-04 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-04 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-04 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-04 Injury None Premature Discharge of Battery
2016-11-04 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-04 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-03 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-03 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-03 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-03 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-03 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-03 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-03 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-03 Injury None Premature Discharge of Battery
2016-11-03 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-03 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-03 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-03 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-03 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-02 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-02 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-02 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-02 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-02 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-02 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-02 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-02 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-02 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-02 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-01 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-01 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-01 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-01 Injury None Premature Discharge of Battery, Nonstandard Device, Delayed Charge Time
2016-11-01 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-01 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-01 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-01 Injury None Premature Discharge of Battery, Failure to Interrogate
2016-11-01 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-31 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-31 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-31 Injury None Inappropriate/Inadequate Shock/Stimulation
2016-10-31 Injury None Premature Discharge of Battery, Failure to Interrogate, Nonstandard Device
2016-10-31 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-30 Malfunction None Inappropriate/Inadequate Shock/Stimulation
2016-10-29 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-28 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-28 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-28 Injury None Premature Discharge of Battery
2016-10-28 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-28 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-28 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-28 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-27 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-27 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-27 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-27 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-26 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-26 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-26 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-26 Malfunction None Defective Alarm
2016-10-26 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-26 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-26 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-26 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-25 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-25 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-25 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-25 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-25 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-25 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-25 Malfunction None Failure to Interrogate
2016-10-24 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-24 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-24 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-24 Injury None Inappropriate/Inadequate Shock/Stimulation, Under-Sensing
2016-10-24 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-24 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-24 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-24 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-23 Death None Adverse Event Without Identified Device or Use Problem
2016-10-22 Injury None Premature Discharge of Battery, Premature Elective Replacement Indicator
2016-10-21 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-21 Injury None Inappropriate/Inadequate Shock/Stimulation
2016-10-21 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-21 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-21 Malfunction None Over-Sensing
2016-10-20 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-20 Injury None Device Operates Differently Than Expected
2016-10-20 Injury None Delayed Charge Time
2016-10-20 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-19 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-19 Injury None Premature Discharge of Battery, Premature Elective Replacement Indicator
2016-10-19 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-19 Injury None Inappropriate/Inadequate Shock/Stimulation
2016-10-19 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-19 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-19 Malfunction None Vibration
2016-10-18 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-18 Injury None Premature Discharge of Battery
2016-10-18 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-17 Injury None High impedance
2016-10-17 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-15 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-15 Injury None Inappropriate/Inadequate Shock/Stimulation
2016-10-14 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-14 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-13 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-13 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-12 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-12 Injury None Premature Discharge of Battery, Battery Problem
2016-10-12 Injury None Premature Discharge of Battery, Inappropriate or Unexpected Reset
2016-10-12 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-11 Injury None Premature Discharge of Battery, Failure to Interrogate
2016-10-10 Malfunction None Inappropriate/Inadequate Shock/Stimulation
2016-10-10 Injury None Inappropriate/Inadequate Shock/Stimulation
2016-10-10 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-08 Injury None Premature Discharge of Battery
2016-10-07 Malfunction None Failure to Interrogate
2016-10-03 Injury None Inappropriate/Inadequate Shock/Stimulation
2016-09-30 Injury None Device Operates Differently Than Expected
2016-09-29 Malfunction None Over-Sensing, Pacing Problem, Device Operates Differently Than Expected
2016-09-25 Injury None Inappropriate/Inadequate Shock/Stimulation, Delayed Charge Time
2016-09-24 Malfunction None Inappropriate/Inadequate Shock/Stimulation
2016-09-24 Injury None Inappropriate/Inadequate Shock/Stimulation
2016-09-23 Malfunction None Over-Sensing
2016-09-21 Injury None Adverse Event Without Identified Device or Use Problem
2016-09-20 Injury None Premature Discharge of Battery, Failure to Interrogate
2016-09-20 Injury None Premature Elective Replacement Indicator
2016-09-19 Malfunction None High impedance
2016-09-18 Injury None Defibrillation/Stimulation Problem, Under-Sensing
2016-09-17 Injury None Adverse Event Without Identified Device or Use Problem
2016-09-17 Injury None Premature Discharge of Battery, Premature Elective Replacement Indicator
2016-09-16 Malfunction None Failure to Capture, Under-Sensing
2016-09-12 Malfunction None Inappropriate/Inadequate Shock/Stimulation
2016-09-12 Injury None Failure to Interrogate
2016-09-12 Injury None Premature Discharge of Battery
2016-09-11 Malfunction None Inappropriate or Unexpected Reset
2016-09-08 Malfunction None High impedance
2016-09-07 Injury None Inappropriate/Inadequate Shock/Stimulation
2016-09-07 Death None Adverse Event Without Identified Device or Use Problem
2016-09-06 Injury None Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2016-09-05 Injury None Premature Elective Replacement Indicator, Inappropriate/Inadequate Shock/Stimulation, Decreased Sensitivity
2016-08-31 Malfunction None Premature Discharge of Battery
2016-08-31 Injury None Pacing Problem
2016-08-31 Injury None Premature Discharge of Battery, Premature Elective Replacement Indicator
2016-08-30 Injury None Failure to Interrogate
2016-08-30 Injury None Over-Sensing
2016-08-30 Injury None Insufficient Information
2016-08-21 Injury None Adverse Event Without Identified Device or Use Problem
2016-08-19 Malfunction None Under-Sensing, Device Operates Differently Than Expected
2016-08-17 Injury None Premature Discharge of Battery, Failure to Interrogate
2016-08-16 Injury None Adverse Event Without Identified Device or Use Problem
2016-08-15 Injury None Premature Discharge of Battery, Inappropriate or Unexpected Reset
2016-08-14 Death None Adverse Event Without Identified Device or Use Problem
2016-08-13 Malfunction None Device Operates Differently Than Expected
2016-08-12 Malfunction None Device Operates Differently Than Expected
2016-08-12 Injury None Inappropriate/Inadequate Shock/Stimulation
2016-08-10 Malfunction None Failure to Interrogate
2016-08-10 Injury None Premature Discharge of Battery
2016-08-03 Malfunction None Failure to Convert Rhythm
2016-08-03 Injury None Failure to Interrogate
2016-08-01 Injury None Adverse Event Without Identified Device or Use Problem
2016-07-29 Injury None Premature Discharge of Battery, Premature Elective Replacement Indicator
2016-07-28 Injury None Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2016-07-28 Death None Failure to Interrogate
2016-07-27 Malfunction None Over-Sensing, Device Operates Differently Than Expected
2016-07-27 Injury None Failure to Interrogate
2016-07-27 Death None Failure to Convert Rhythm, Inappropriate or Unexpected Reset, Output Problem
2016-07-25 Injury None Premature Discharge of Battery, Premature Elective Replacement Indicator
2016-07-22 Injury None Premature Discharge of Battery, Premature Elective Replacement Indicator
2016-07-22 Injury None Over-Sensing, Inappropriate/Inadequate Shock/Stimulation, Decreased Sensitivity
2016-07-16 Injury None Premature Discharge of Battery, Failure to Interrogate, Over-Sensing
2016-07-15 Injury None Premature Discharge of Battery
2016-07-13 Injury None Inappropriate/Inadequate Shock/Stimulation
2016-07-12 Injury None Premature Discharge of Battery, Inappropriate or Unexpected Reset
2016-07-11 Malfunction None Inappropriate or Unexpected Reset
2016-07-07 Malfunction None Device Operates Differently Than Expected
2016-07-07 Injury None Migration or Expulsion of Device, High Capture Threshold
2016-07-07 Malfunction None Over-Sensing
2016-06-30 Malfunction None High impedance
2016-06-30 Malfunction None Device Operates Differently Than Expected
2016-06-29 Malfunction None Pacing Problem, Device Operates Differently Than Expected
2016-06-28 Injury None Defibrillation/Stimulation Problem
2016-06-27 Injury None Inappropriate/Inadequate Shock/Stimulation
2016-06-23 Injury None Inappropriate/Inadequate Shock/Stimulation
2016-06-21 Malfunction None Premature Discharge of Battery
2016-06-19 Injury None Inappropriate/Inadequate Shock/Stimulation
2016-06-16 Malfunction None Difficult to Interrogate, Inappropriate or Unexpected Reset
2016-06-16 Injury None Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2016-06-16 Malfunction None Failure to Interrogate
2016-06-15 Injury None Inappropriate/Inadequate Shock/Stimulation, Inappropriate or Unexpected Reset
2016-06-13 Injury None Premature Discharge of Battery, Failure to Interrogate, Device Operates Differently Than Expected
2016-06-10 Injury None Premature Discharge of Battery, Failure to Interrogate
2016-06-08 Injury None Premature Discharge of Battery, Inappropriate or Unexpected Reset
2016-06-07 Injury None Premature Discharge of Battery, Premature Elective Replacement Indicator
2016-06-06 Injury None Premature Discharge of Battery, Premature End-of-Life Indicator
2016-06-05 Injury None Premature Discharge of Battery, Failure to Interrogate, Pacing Problem
2016-06-04 Injury None Inappropriate/Inadequate Shock/Stimulation
2016-05-13 Malfunction None Device Operates Differently Than Expected
2016-05-05 Death None Adverse Event Without Identified Device or Use Problem
2016-05-05 Malfunction None Over-Sensing
2016-05-01 Injury None Premature Discharge of Battery
2016-04-08 Injury None Inappropriate/Inadequate Shock/Stimulation
2016-02-12 Injury None Delayed Charge Time, Adverse Event Without Identified Device or Use Problem
2016-01-31 Injury None Premature Discharge of Battery
2016-01-31 Death None Adverse Event Without Identified Device or Use Problem
2016-01-26 Injury None Adverse Event Without Identified Device or Use Problem
2015-12-16 Injury None Over-Sensing
2015-08-12 Death None Adverse Event Without Identified Device or Use Problem
2015-08-01 Injury None Premature Discharge of Battery, Premature Elective Replacement Indicator
2015-05-25 Injury None Premature Discharge of Battery
2015-05-15 Injury None Inappropriate/Inadequate Shock/Stimulation
2015-04-29 Injury None Premature Discharge of Battery, Failure to Interrogate
2015-04-23 Injury None Inappropriate/Inadequate Shock/Stimulation, Inappropriate or Unexpected Reset
2015-04-15 Injury None Inappropriate/Inadequate Shock/Stimulation
2015-04-13 Death None Failure to Interrogate, Defibrillation/Stimulation Problem, Inappropriate or Unexpected Reset
2015-04-06 Injury None Premature Discharge of Battery, Failure to Interrogate
2015-03-30 Malfunction None Premature Discharge of Battery, Premature Elective Replacement Indicator
2015-03-29 Injury None Premature Elective Replacement Indicator
2015-03-29 Injury None Premature Elective Replacement Indicator
2015-03-27 Injury None Inappropriate/Inadequate Shock/Stimulation
2015-03-27 Injury None Over-Sensing
2015-03-24 Injury None High impedance
2015-03-24 Injury None Inappropriate/Inadequate Shock/Stimulation
2015-03-21 Injury None Inappropriate/Inadequate Shock/Stimulation
2015-03-19 Malfunction None High impedance
2015-03-18 Malfunction None Over-Sensing
2015-03-12 Injury None Inappropriate/Inadequate Shock/Stimulation
2015-03-12 Injury None Premature Elective Replacement Indicator
2015-03-12 Injury None Failure to Interrogate, Premature Elective Replacement Indicator
2015-03-12 Injury None Inappropriate/Inadequate Shock/Stimulation
2015-03-12 Injury None Premature Elective Replacement Indicator
2015-02-26 Malfunction None Premature Discharge of Battery
2015-02-23 Malfunction None Device Operates Differently Than Expected
2015-02-22 Injury None Inappropriate/Inadequate Shock/Stimulation
2015-02-12 Injury None Premature Elective Replacement Indicator
2015-02-12 Injury None Premature Elective Replacement Indicator
2015-02-10 Injury None Premature Elective Replacement Indicator
2015-02-10 Injury None Premature Elective Replacement Indicator
2015-02-09 Injury None Premature Discharge of Battery
2015-02-03 Injury None Failure to Interrogate
2015-02-03 Injury None Failure to Interrogate
2015-01-30 Death None Adverse Event Without Identified Device or Use Problem
2015-01-15 Injury None Premature Discharge of Battery
2015-01-12 Injury None Premature Discharge of Battery
2014-12-24 Injury None Premature Discharge of Battery, Low impedance
2014-12-24 Injury None Premature Discharge of Battery, Low impedance
2014-12-22 Injury None Failure to Interrogate, Pacing Problem
2014-12-09 Injury None Premature Discharge of Battery
2014-11-13 Injury None Premature Discharge of Battery, Failure to Interrogate
2014-11-13 Injury None Premature Discharge of Battery, Failure to Interrogate
2014-11-10 Injury None Failure to Interrogate, Premature Elective Replacement Indicator
2014-11-05 Injury None Premature Elective Replacement Indicator
2014-11-03 Injury None Premature Discharge of Battery, Failure to Interrogate
2014-10-17 Injury None Premature Discharge of Battery, Failure to Interrogate
2014-10-16 Injury None Failure to Interrogate, Pacing Problem
2014-10-14 Injury None Failure to Interrogate
2014-10-09 Injury None Premature Discharge of Battery
2014-09-21 Malfunction None High impedance
2014-09-19 Injury None Failure to Interrogate
2014-09-10 Injury None Failure to Interrogate, Premature End-of-Life Indicator
2014-09-06 Injury None Output Problem
2014-09-04 Injury None Premature Discharge of Battery
2014-08-27 Injury None Failure to Interrogate, Inappropriate or Unexpected Reset
2014-08-21 Injury None Failure to Interrogate
2014-08-18 Injury None Premature Elective Replacement Indicator
2014-07-25 Malfunction None False Alarm
2014-07-17 Injury None Premature Elective Replacement Indicator
2014-07-16 Malfunction None False Alarm
2014-07-15 Injury None Premature Discharge of Battery
2014-07-15 Injury None Premature Discharge of Battery
2014-07-10 Injury None Inappropriate/Inadequate Shock/Stimulation
2014-07-09 Malfunction None False Alarm
2014-07-07 Injury None Premature Elective Replacement Indicator
2014-07-03 Malfunction None Device Operates Differently Than Expected
2014-07-02 Malfunction None False Alarm
2014-07-02 Malfunction None False Alarm
2014-06-30 Malfunction None Device Operates Differently Than Expected
2014-06-30 Malfunction None Device Operates Differently Than Expected
2014-06-30 Malfunction None False Alarm
2014-06-27 Injury None Premature End-of-Life Indicator, Premature Elective Replacement Indicator
2014-06-26 Malfunction None False Alarm
2014-06-24 Malfunction None False Alarm
2014-06-24 Malfunction None False Alarm
2014-06-24 Malfunction None False Alarm
2014-06-24 Malfunction None False Alarm
2014-06-23 Malfunction None False Alarm
2014-06-19 Malfunction None Over-Sensing, Decreased Sensitivity
2014-06-19 Malfunction None False Alarm
2014-06-19 Malfunction None False Alarm
2014-06-19 Malfunction None False Alarm
2014-06-17 Malfunction None False Alarm
2014-06-17 Malfunction None False Alarm
2014-06-17 Malfunction None Over-Sensing
2014-06-17 Malfunction None False Alarm
2014-06-17 Injury None Premature Elective Replacement Indicator
2014-06-16 Malfunction None False Alarm
2014-06-15 Injury None Inappropriate/Inadequate Shock/Stimulation
2014-06-13 Malfunction None False Alarm
2014-06-13 Malfunction None False Alarm
2014-06-12 Malfunction None Over-Sensing
2014-06-12 Malfunction None False Alarm
2014-06-11 Death None Adverse Event Without Identified Device or Use Problem
2014-06-11 Malfunction None False Alarm
2014-06-11 Malfunction None False Alarm
2014-06-09 Injury None Inappropriate/Inadequate Shock/Stimulation
2014-06-09 Malfunction None False Alarm
2014-06-09 Malfunction None False Alarm
2014-06-05 Injury None Difficult to Interrogate
2014-06-03 Injury None Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2014-05-29 Malfunction None Adverse Event Without Identified Device or Use Problem
2014-05-29 Malfunction None False Alarm
2014-05-29 Malfunction None False Alarm
2014-05-28 Injury None Failure to Interrogate, Material Protrusion/Extrusion
2014-05-28 Injury None Inappropriate/Inadequate Shock/Stimulation
2014-05-28 Injury None Failure to Interrogate, Material Protrusion/Extrusion
2014-05-27 Death None Adverse Event Without Identified Device or Use Problem
2014-05-26 Injury None Inappropriate/Inadequate Shock/Stimulation
2014-05-22 Injury None Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2014-05-21 Malfunction None Failure to Interrogate
2014-05-20 Malfunction None False Alarm
2014-05-20 Injury None Premature Discharge of Battery, Failure to Interrogate
2014-05-19 Malfunction None Failure to Interrogate
2014-05-19 Malfunction None False Alarm
2014-05-18 Malfunction None Under-Sensing
2014-05-18 Malfunction None Under-Sensing, Device Sensing Problem
2014-05-15 Malfunction None False Alarm
2014-05-14 Malfunction None False Alarm
2014-05-12 Injury None Premature Elective Replacement Indicator
2014-05-12 Malfunction None False Alarm
2014-05-12 Malfunction None False Alarm
2014-05-09 Malfunction None False Alarm
2014-05-08 Malfunction None Failure to Interrogate
2014-05-08 Malfunction None False Alarm
2014-05-07 Malfunction None Over-Sensing
2014-05-06 Malfunction None Over-Sensing
2014-05-05 Injury None Inappropriate or Unexpected Reset
2014-05-05 Injury None Inappropriate or Unexpected Reset
2014-05-05 Malfunction None False Alarm
2014-05-05 Malfunction None False Alarm
2014-05-02 Malfunction None False Alarm
2014-05-02 Malfunction None Over-Sensing
2014-04-29 Malfunction None Failure to Interrogate
2014-04-27 Death None Adverse Event Without Identified Device or Use Problem
2014-04-25 Injury None Premature End-of-Life Indicator
2014-04-25 Injury None Premature End-of-Life Indicator
2014-04-24 Malfunction None False Alarm
2014-04-24 Malfunction None False Alarm
2014-04-22 Injury None Inappropriate/Inadequate Shock/Stimulation
2014-04-22 Injury None Premature Discharge of Battery, Premature Elective Replacement Indicator
2014-04-19 Malfunction None Over-Sensing
2014-04-18 Death None Adverse Event Without Identified Device or Use Problem
2014-04-18 Malfunction None False Alarm
2014-04-16 Malfunction None Device Operates Differently Than Expected
2014-04-16 Malfunction None False Alarm
2014-04-15 Malfunction None False Alarm
2014-04-14 Malfunction None False Alarm
2014-04-14 Injury None Premature End-of-Life Indicator
2014-04-14 Injury None Premature End-of-Life Indicator
2014-04-11 Malfunction None False Alarm
2014-04-10 Malfunction None False Alarm
2014-04-09 Malfunction None Over-Sensing
2014-04-09 Injury None Inappropriate/Inadequate Shock/Stimulation
2014-04-08 Malfunction None False Alarm
2014-04-07 Injury None Failure to Convert Rhythm, Delayed Charge Time
2014-04-07 Injury None Premature Discharge of Battery, Failure to Interrogate, Output Problem
2014-04-07 Malfunction None Sensing Intermittently
2014-04-07 Injury None Premature Discharge of Battery, Failure to Interrogate, Output Problem
2014-04-07 Injury None Premature Elective Replacement Indicator
2014-04-07 Injury None Premature Elective Replacement Indicator
2014-04-03 Injury None Inappropriate/Inadequate Shock/Stimulation
2014-04-01 Injury None Inappropriate/Inadequate Shock/Stimulation
2014-04-01 Malfunction None False Alarm
2014-03-31 Malfunction Insufficient Information High impedance
2014-03-31 Malfunction None False Alarm
2014-03-29 Injury None Inappropriate/Inadequate Shock/Stimulation
2014-03-28 Malfunction None False Alarm
2014-03-27 Malfunction None High impedance, Pacing Problem
2014-03-27 Injury None Inappropriate or Unexpected Reset
2014-03-26 Injury None Inappropriate/Inadequate Shock/Stimulation
2014-03-26 Malfunction None Difficult to Interrogate
2014-03-25 Injury None Premature Elective Replacement Indicator
2014-03-25 Injury None Premature Elective Replacement Indicator
2014-03-24 Malfunction None False Alarm
2014-03-21 Injury None Inappropriate/Inadequate Shock/Stimulation
2014-03-21 Malfunction None Device Operates Differently Than Expected
2014-03-20 Malfunction None False Alarm
2014-03-19 Injury None Migration or Expulsion of Device
2014-03-19 Malfunction None False Alarm
2014-03-18 Malfunction None Inappropriate/Inadequate Shock/Stimulation
2014-03-17 Injury None Inappropriate/Inadequate Shock/Stimulation
2014-03-15 Injury None Premature Discharge of Battery
2014-03-15 Injury None Premature Discharge of Battery
2014-03-14 Injury None Inappropriate/Inadequate Shock/Stimulation
2014-03-12 Injury None Inappropriate/Inadequate Shock/Stimulation
2014-03-10 Injury None Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2014-03-08 Injury None Inappropriate/Inadequate Shock/Stimulation
2014-03-06 Malfunction None False Alarm
2014-03-05 Malfunction None False Alarm
2014-03-05 Malfunction None False Alarm
2014-03-05 Malfunction None False Alarm
2014-03-04 Injury None Inappropriate/Inadequate Shock/Stimulation
2014-02-27 Injury None Inappropriate/Inadequate Shock/Stimulation
2014-02-25 Injury None Premature Discharge of Battery
2014-02-25 Injury None Premature Discharge of Battery
2014-02-24 Malfunction None False Alarm
2014-02-24 Malfunction None False Alarm
2014-02-22 Malfunction None High impedance, Failure to Convert Rhythm
2014-02-18 Malfunction None False Alarm
2014-02-17 Malfunction None False Alarm
2014-02-17 Malfunction None False Alarm
2014-02-13 Injury None Inappropriate/Inadequate Shock/Stimulation
2014-02-12 Malfunction None Over-Sensing
2014-02-10 Malfunction None False Alarm
2014-02-07 Injury None Inappropriate/Inadequate Shock/Stimulation
2014-02-07 Malfunction None Device Operates Differently Than Expected
2014-02-05 Malfunction None False Alarm
2014-02-03 Malfunction None Inappropriate/Inadequate Shock/Stimulation, Output Problem
2014-02-03 Injury None Premature Elective Replacement Indicator
2014-02-01 Injury None Inappropriate/Inadequate Shock/Stimulation
2014-02-01 Injury None Inappropriate/Inadequate Shock/Stimulation
2014-01-31 Malfunction None False Alarm
2014-01-24 Malfunction None Device Sensing Problem
2014-01-23 Injury None Failure to Interrogate
2014-01-23 Injury None Failure to Interrogate
2014-01-23 Malfunction None Difficult to Interrogate, Pacing Problem
2014-01-21 Malfunction None Over-Sensing
2014-01-21 Injury None Inappropriate/Inadequate Shock/Stimulation
2014-01-21 Malfunction None False Alarm
2014-01-21 Malfunction None False Alarm
2014-01-21 Malfunction None False Alarm
2014-01-21 Malfunction None False Alarm
2014-01-19 Death None Adverse Event Without Identified Device or Use Problem
2014-01-16 Injury None Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2014-01-16 Malfunction None False Alarm
2014-01-16 Injury None Premature Elective Replacement Indicator
2014-01-16 Injury None Inappropriate/Inadequate Shock/Stimulation
2014-01-16 Injury None Premature Elective Replacement Indicator
2014-01-16 Malfunction None False Alarm
2014-01-15 Malfunction None False Alarm
2014-01-15 Death None Under-Sensing
2014-01-15 Injury None Inappropriate/Inadequate Shock/Stimulation
2014-01-13 Malfunction None Failure to Interrogate
2014-01-13 Malfunction None Failure to Interrogate
2014-01-13 Injury None Inappropriate/Inadequate Shock/Stimulation
2014-01-13 Malfunction None Failure to Interrogate
2014-01-13 Malfunction None Failure to Interrogate
2014-01-13 Malfunction None False Alarm
2014-01-13 Malfunction None Failure to Interrogate
2014-01-09 Injury None Over-Sensing
2014-01-07 Malfunction None False Alarm
2014-01-06 Malfunction None False Alarm, Device Operates Differently Than Expected
2014-01-06 Injury None Premature Discharge of Battery
2014-01-06 Injury None Premature Discharge of Battery
2014-01-06 Injury None Premature Elective Replacement Indicator
2014-01-06 Injury None Premature Elective Replacement Indicator
2014-01-03 Malfunction None False Alarm, Device Displays Incorrect Message
2014-01-02 Malfunction None Under-Sensing, Device Operates Differently Than Expected
2013-12-31 Injury None Premature Discharge of Battery
2013-12-31 Injury None Premature Discharge of Battery
2013-12-30 Injury None Failure to Interrogate, Premature Elective Replacement Indicator
2013-12-30 Injury None Failure to Interrogate, Premature Elective Replacement Indicator
2013-12-27 Malfunction None Inappropriate or Unexpected Reset
2013-12-27 Malfunction None Over-Sensing
2013-12-27 Injury None Over-Sensing, Inappropriate/Inadequate Shock/Stimulation, Delayed Charge Time
2013-12-26 Death None Adverse Event Without Identified Device or Use Problem
2013-12-26 Injury None Inappropriate/Inadequate Shock/Stimulation, Inappropriate or Unexpected Reset
2013-12-26 Injury None Inappropriate/Inadequate Shock/Stimulation
2013-12-24 Injury None Inappropriate/Inadequate Shock/Stimulation
2013-12-21 Injury None Inappropriate or Unexpected Reset
2013-12-19 Injury None Inappropriate/Inadequate Shock/Stimulation
2013-12-18 Injury None Capturing Problem
2013-12-17 Injury None Failure to Interrogate
2013-12-17 Injury None Failure to Interrogate
2013-12-14 Injury None Inappropriate/Inadequate Shock/Stimulation
2013-12-14 Malfunction None False Alarm
2013-12-13 Injury None Inappropriate/Inadequate Shock/Stimulation
2013-12-09 Malfunction None High impedance
2013-12-03 Malfunction None Over-Sensing
2013-12-03 Injury None Inappropriate/Inadequate Shock/Stimulation
2013-12-02 Injury None Inappropriate/Inadequate Shock/Stimulation
2013-11-28 Injury None Inappropriate/Inadequate Shock/Stimulation
2013-11-27 Injury None Inappropriate/Inadequate Shock/Stimulation
2013-11-27 Injury None None
2013-11-23 Injury None Inappropriate/Inadequate Shock/Stimulation
2013-11-22 Malfunction None None
2013-11-19 Injury None Premature Discharge of Battery, Failure to Interrogate
2013-11-19 Injury None Premature Discharge of Battery, Failure to Interrogate
2013-11-18 Injury None Premature Discharge of Battery
2013-11-18 Injury None Premature Discharge of Battery
2013-11-16 Injury None Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2013-11-15 Malfunction None None
2013-11-11 Injury None Failure to Interrogate
2013-11-11 Injury None None
2013-11-08 Malfunction None None
2013-11-07 Malfunction None None
2013-11-06 Injury None None
2013-11-06 Injury None Failure to Interrogate, Premature Elective Replacement Indicator
2013-11-06 Injury None Failure to Interrogate, Premature Elective Replacement Indicator
2013-11-04 Injury None None
2013-10-30 Injury None None
2013-10-30 Injury None Premature Elective Replacement Indicator
2013-10-30 Injury None None
2013-10-28 Malfunction None Adverse Event Without Identified Device or Use Problem
2013-10-24 Injury None Inappropriate/Inadequate Shock/Stimulation
2013-10-22 Injury None Premature Discharge of Battery, Failure to Interrogate
2013-10-22 Injury None None
2013-10-16 Injury None Inappropriate/Inadequate Shock/Stimulation
2013-10-11 Malfunction None None
2013-10-10 Injury None Premature Elective Replacement Indicator
2013-10-10 Injury None None
2013-10-10 Malfunction None None
2013-10-09 Injury None None
2013-10-09 Injury None None
2013-10-09 Injury None Premature Discharge of Battery
2013-10-08 Malfunction None None
2013-10-07 Injury None None
2013-10-06 Injury None Intermittent Capture, Failure to Interrogate
2013-10-06 Injury None None
2013-10-04 Malfunction None None
2013-10-02 Injury None Premature Discharge of Battery
2013-10-02 Injury None None
2013-10-01 Injury None None
2013-09-27 Malfunction None None
2013-09-27 Malfunction None None
2013-09-24 Injury None None
2013-09-23 Injury None None
2013-09-19 Malfunction None None
2013-09-17 Injury None Premature End-of-Life Indicator, Premature Elective Replacement Indicator
2013-09-17 Injury None None
2013-09-16 Injury None None
2013-09-16 Injury None Failure to Interrogate, Premature Elective Replacement Indicator
2013-09-15 Injury None None
2013-09-14 Malfunction None None
2013-09-14 Death None None
2013-09-13 Malfunction None None
2013-09-09 Injury None Failure to Interrogate
2013-09-09 Injury None None
2013-09-06 Injury None Premature Elective Replacement Indicator
2013-09-06 Injury None None
2013-09-04 Injury None None
2013-09-03 Injury None None
2013-09-03 Injury None Premature End-of-Life Indicator
2013-09-03 Injury None None
2013-08-30 Malfunction None None
2013-08-29 Malfunction None None
2013-08-29 Injury None None
2013-08-28 Injury None None
2013-08-27 Injury None None
2013-08-23 Malfunction None Under-Sensing
2013-08-21 Malfunction None None
2013-08-19 Injury None None
2013-08-18 Malfunction None None
2013-08-17 Injury None None
2013-08-15 Malfunction None None
2013-08-12 Malfunction None None
2013-08-08 Malfunction None None
2013-08-03 Injury None None
2013-08-01 Injury None None
2013-07-31 Malfunction None None
2013-07-31 Injury None None
2013-07-30 Malfunction None None
2013-07-27 Injury None None
2013-07-22 Injury None None
2013-07-22 Injury None None
2013-07-16 Injury None None
2013-07-16 Injury None Premature Discharge of Battery
2013-07-12 Injury None None
2013-07-11 Injury None None
2013-07-11 Injury None Premature Discharge of Battery, Output Problem
2013-07-11 Malfunction None None
2013-07-01 Malfunction None None
2013-06-28 Death None None
2013-06-27 Death None None
2013-06-27 Injury None None
2013-06-25 Injury None None
2013-06-25 Injury None None
2013-06-25 Malfunction None None
2013-06-25 Injury None Premature Discharge of Battery, Communication or Transmission Problem
2013-06-24 Malfunction None None
2013-06-23 Injury None None
2013-06-23 Death None None
2013-06-19 Injury None None
2013-06-18 Injury None None
2013-06-13 Injury None None
2013-06-07 Injury None None
2013-06-06 Injury None None
2013-06-05 Injury None None
2013-05-29 Injury None None
2013-05-19 Malfunction None None
2013-05-19 Injury None None
2013-05-19 Injury None Premature Elective Replacement Indicator
2013-05-16 Malfunction None None
2013-05-13 Injury None None
2013-05-10 Injury None None
2013-05-10 Injury None None
2013-05-08 Injury None None
2013-05-08 Injury None None
2013-05-06 Injury None None
2013-05-06 Malfunction None None
2013-05-01 Malfunction None None
2013-04-30 Injury None None
2013-04-27 Injury None None
2013-04-27 Injury None Premature Elective Replacement Indicator
2013-04-26 Injury None None
2013-04-25 Malfunction None None
2013-04-24 Malfunction None None
2013-04-19 Injury None None
2013-04-18 Injury None Premature Discharge of Battery
2013-04-18 Malfunction None None
2013-04-18 Injury None None
2013-04-18 Malfunction None None
2013-04-17 Injury None None
2013-04-16 Malfunction None None
2013-04-15 Injury None Premature Elective Replacement Indicator
2013-04-15 Injury None None
2013-04-15 Injury None None
2013-04-11 Injury None None
2013-04-11 Injury None Premature Elective Replacement Indicator
2013-04-11 Malfunction None None
2013-04-10 Malfunction None None
2013-04-10 Injury None None
2013-04-10 Injury None None
2013-04-02 Injury None Failure to Interrogate
2013-04-02 Injury None None
2013-04-02 Injury None None
2013-04-02 Injury None None
2013-03-29 Death None None
2013-03-29 Injury None None
2013-03-28 Malfunction None None
2013-03-22 Injury None None
2013-03-21 Death None None
2013-03-14 Injury None None
2013-03-14 Injury None None
2013-03-07 Malfunction None None
2013-03-06 Malfunction None None
2013-03-06 Injury None None
2013-03-04 Malfunction None None
2013-03-01 Malfunction None None
2013-02-27 Injury None None
2013-02-26 Malfunction None None
2013-02-21 Malfunction None None
2013-02-15 Malfunction None None
2013-02-13 Injury None None
2013-02-13 Injury None None
2013-02-12 Injury None None
2013-02-08 Injury None None
2013-02-08 Malfunction None None
2013-02-07 Malfunction None None
2013-02-06 Malfunction None None
2013-02-01 Injury None None
2013-01-29 Injury None Inappropriate/Inadequate Shock/Stimulation
2013-01-18 Malfunction None Over-Sensing
2013-01-16 Malfunction None None
2013-01-15 Malfunction None None
2013-01-14 Injury None Inappropriate/Inadequate Shock/Stimulation
2013-01-04 Malfunction None None
2013-01-01 Injury None Adverse Event Without Identified Device or Use Problem
2012-12-26 Injury None Inappropriate/Inadequate Shock/Stimulation
2012-12-14 Injury None Inappropriate/Inadequate Shock/Stimulation
2012-12-14 Malfunction None None
2012-12-13 Malfunction None None
2012-12-10 Injury None Inappropriate/Inadequate Shock/Stimulation
2012-12-08 Malfunction None None
2012-12-07 Injury None None
2012-12-07 Malfunction None Over-Sensing
2012-12-05 Malfunction None Device Operates Differently Than Expected
2012-11-27 Malfunction None Over-Sensing
2012-11-24 Injury None None
2012-11-23 Malfunction None Under-Sensing
2012-11-20 Malfunction None None
2012-11-19 Injury None Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2012-11-14 Injury None Inappropriate/Inadequate Shock/Stimulation
2012-11-05 Death None None
2012-11-05 Malfunction None Over-Sensing
2012-11-05 Injury None Inappropriate/Inadequate Shock/Stimulation
2012-11-02 Injury None Inappropriate/Inadequate Shock/Stimulation
2012-11-01 Injury None Inappropriate/Inadequate Shock/Stimulation
2012-10-24 Malfunction None Over-Sensing
2012-10-17 Malfunction None Failure to Interrogate
2012-10-17 Malfunction None High impedance
2012-10-12 Injury None Adverse Event Without Identified Device or Use Problem
2012-10-12 Malfunction None Over-Sensing
2012-09-28 Injury None Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2012-09-28 Malfunction None Device Displays Incorrect Message
2012-09-26 Malfunction None Over-Sensing
2012-09-25 Malfunction None High impedance, Connection Problem, Device Sensing Problem
2012-09-24 Injury None Adverse Event Without Identified Device or Use Problem
2012-09-12 Malfunction None None
2012-08-30 Malfunction None Over-Sensing
2012-08-27 Malfunction None None
2012-08-27 Injury None Inappropriate/Inadequate Shock/Stimulation
2012-08-23 Death None None
2012-08-21 Malfunction None None
2012-08-17 Malfunction None High Capture Threshold
2012-08-15 Malfunction None None
2012-08-10 Malfunction None Intermittent Capture
2012-08-09 Injury None Premature Discharge of Battery
2012-08-09 Injury None Inappropriate/Inadequate Shock/Stimulation
2012-08-09 Injury None Inappropriate/Inadequate Shock/Stimulation
2012-08-07 Injury None Inappropriate/Inadequate Shock/Stimulation
2012-08-07 Malfunction None None
2012-08-07 Malfunction None Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2012-08-03 Injury None Inappropriate/Inadequate Shock/Stimulation
2012-08-02 Injury None Inappropriate/Inadequate Shock/Stimulation
2012-07-30 Injury None Inappropriate/Inadequate Shock/Stimulation
2012-07-30 Malfunction None Inappropriate or Unexpected Reset
2012-07-24 Injury None Inappropriate/Inadequate Shock/Stimulation
2012-07-24 Malfunction None Over-Sensing
2012-07-10 Malfunction None Over-Sensing
2012-07-09 Injury None Inappropriate/Inadequate Shock/Stimulation
2012-06-22 Injury None None
2012-06-21 Malfunction None Inappropriate or Unexpected Reset
2012-06-15 Malfunction None Connection Problem
2012-06-07 Malfunction None High impedance
2012-06-07 Injury None Inappropriate/Inadequate Shock/Stimulation, Under-Sensing
2012-06-01 Malfunction None Intermittent Capture, High Capture Threshold
2012-06-01 Malfunction None Inappropriate or Unexpected Reset
2012-05-29 Injury None Inappropriate/Inadequate Shock/Stimulation
2012-05-25 Malfunction None Premature Elective Replacement Indicator
2012-05-21 Injury None Inappropriate/Inadequate Shock/Stimulation
2012-05-18 Injury None Inappropriate/Inadequate Shock/Stimulation
2012-05-16 Injury None Premature Elective Replacement Indicator
2012-05-16 Injury None None
2012-05-10 Malfunction None High impedance
2012-05-08 Injury None None
2012-05-07 Malfunction None Connection Problem
2012-05-05 Death None None
2012-04-30 Malfunction None Over-Sensing
2012-04-27 Injury None None
2012-04-26 Injury None Inappropriate/Inadequate Shock/Stimulation
2012-04-24 Injury None Failure to Convert Rhythm
2012-04-19 Injury None Inappropriate/Inadequate Shock/Stimulation
2012-04-13 Injury None None
2012-04-11 Injury None None
2012-04-10 Injury None Inappropriate/Inadequate Shock/Stimulation
2012-04-06 Malfunction None High impedance
2012-04-06 Injury None None
2012-04-06 Injury None Inappropriate/Inadequate Shock/Stimulation
2012-04-02 Injury None None
2012-03-30 Injury None None
2012-03-29 Injury None Inappropriate/Inadequate Shock/Stimulation
2012-03-29 Injury None Inappropriate/Inadequate Shock/Stimulation
2012-03-29 Injury None None
2012-03-28 Malfunction None Device Displays Incorrect Message
2012-03-28 Malfunction None Over-Sensing
2012-03-27 Injury None Inappropriate/Inadequate Shock/Stimulation
2012-03-23 Malfunction None Inappropriate or Unexpected Reset
2012-03-22 Injury None None
2012-03-22 Injury None None
2012-03-20 Injury None None
2012-03-19 Injury None None
2012-03-15 Malfunction None Device Displays Incorrect Message
2012-03-15 Injury None None
2012-03-13 Malfunction None Over-Sensing
2012-03-09 Injury None None
2012-03-06 Injury None None
2012-03-05 Injury None None
2012-03-03 Injury None None
2012-03-02 Injury None None
2012-03-02 Malfunction None Failure to Interrogate
2012-02-28 Injury None Inappropriate/Inadequate Shock/Stimulation
2012-02-23 Injury None Inappropriate/Inadequate Shock/Stimulation
2012-02-17 Injury None None
2012-02-16 Malfunction None Over-Sensing
2012-02-16 Malfunction None Device Operates Differently Than Expected
2012-02-09 Injury None Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2012-02-03 Injury None None
2012-02-03 Death None None
2012-01-31 Injury None None
2012-01-31 Injury None None
2012-01-31 Malfunction None None
2012-01-27 Malfunction None None
2012-01-27 Injury None Inappropriate/Inadequate Shock/Stimulation
2012-01-25 Injury None Inappropriate/Inadequate Shock/Stimulation
2012-01-24 Injury None Delayed Charge Time, Device Operates Differently Than Expected
2012-01-23 Injury None None
2012-01-21 Injury None Inappropriate/Inadequate Shock/Stimulation
2012-01-19 Injury None Inappropriate/Inadequate Shock/Stimulation
2012-01-18 Injury None None
2012-01-18 Injury None None
2012-01-16 Malfunction None Over-Sensing
2012-01-13 Injury None None
2012-01-12 Injury None None
2012-01-05 Injury None None
2012-01-03 Malfunction None Device Operates Differently Than Expected
2011-12-30 Injury None None
2011-12-27 Injury None Inappropriate/Inadequate Shock/Stimulation
2011-12-22 Injury None None
2011-12-21 Injury None None
2011-12-16 Malfunction None Over-Sensing
2011-12-13 Injury None None
2011-11-30 Injury None None
2011-11-29 Injury None Inappropriate/Inadequate Shock/Stimulation
2011-11-29 Injury None Inappropriate/Inadequate Shock/Stimulation
2011-11-23 Injury None Inappropriate/Inadequate Shock/Stimulation
2011-11-21 Death None Adverse Event Without Identified Device or Use Problem
2011-11-21 Malfunction None Over-Sensing, Low impedance
2011-11-17 Injury None None
2011-11-07 Injury None None
2011-11-02 Malfunction None Failure to Interrogate
2011-11-01 Injury None Inappropriate/Inadequate Shock/Stimulation
2011-11-01 Malfunction None Over-Sensing
2011-10-31 Injury None None
2011-10-27 Injury None None
2011-10-27 Injury None None
2011-10-26 Injury None None
2011-10-19 Injury None None
2011-10-14 Malfunction None Output Problem
2011-10-11 Injury None Inappropriate/Inadequate Shock/Stimulation
2011-10-07 Malfunction None Output Problem
2011-10-07 Malfunction None High impedance
2011-10-07 Injury None None
2011-10-06 Injury None Inappropriate/Inadequate Shock/Stimulation
2011-10-06 Malfunction None Failure to Interrogate
2011-09-30 Death None None
2011-09-29 Injury None None
2011-09-26 Injury None Inappropriate/Inadequate Shock/Stimulation
2011-09-26 Injury None None
2011-09-23 Malfunction None Inappropriate/Inadequate Shock/Stimulation
2011-09-22 Injury None None
2011-09-21 Injury None None
2011-09-21 Malfunction None Device Displays Incorrect Message
2011-09-19 Injury None None
2011-09-18 Injury None Inappropriate/Inadequate Shock/Stimulation
2011-09-17 Injury None None
2011-09-16 Injury None Inappropriate/Inadequate Shock/Stimulation
2011-09-08 Injury None None
2011-09-06 Malfunction None Device Displays Incorrect Message
2011-09-06 Injury None Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2011-08-24 Injury None None
2011-08-22 Malfunction None Failure to Interrogate
2011-08-15 Injury None None
2011-08-15 Malfunction None Inappropriate or Unexpected Reset
2011-08-12 Injury None None
2011-08-11 Injury None None
2011-08-09 Injury None None
2011-08-09 Injury None None
2011-08-04 Malfunction None Inappropriate or Unexpected Reset
2011-08-04 Injury None None
2011-08-02 Injury None None
2011-07-19 Malfunction None None
2011-07-15 Injury None None
2011-07-15 Injury None None
2011-07-14 Injury None None
2011-07-14 Injury None None
2011-07-13 Injury None None
2011-07-11 Malfunction None None
2011-07-11 Injury None None
2011-07-07 Malfunction None Over-Sensing
2011-06-26 Death None None
2011-06-23 Malfunction None None
2011-06-22 Injury None None
2011-06-22 Injury None None
2011-06-20 Injury None None
2011-06-15 Injury None None
2011-06-15 Malfunction None Decreased Sensitivity
2011-06-14 Injury None None
2011-06-12 Injury None None
2011-06-09 Death None None
2011-06-08 Injury None None
2011-06-02 Malfunction None Over-Sensing
2011-05-31 Injury None None
2011-05-20 Injury None None
2011-05-20 Injury None None
2011-05-12 Injury None None
2011-05-10 Injury None None
2011-05-07 Injury None None
2011-05-06 Injury None None
2011-05-04 Injury None None
2011-05-02 Injury None None
2011-05-02 Malfunction None Failure to Interrogate
2011-04-28 Injury None None
2011-04-27 Injury None None
2011-04-21 Injury None None
2011-04-18 Injury None None
2011-04-18 Injury None None
2011-04-14 Malfunction None Failure to Interrogate
2011-04-14 Injury None None
2011-04-13 Injury None None
2011-04-09 Death None None
2011-03-29 Death None None
2011-03-29 Injury None None
2011-03-24 Injury None None
2011-03-21 Injury None None
2011-03-16 Injury None None
2011-03-10 Death None None
2011-03-09 Injury None None
2011-03-04 Injury None None
2011-02-25 Injury None None
2011-02-22 Injury None None
2011-02-21 Injury None None
2011-02-18 Injury None None
2011-02-11 Injury None None
2011-02-01 Injury None None
2011-01-31 Injury None None
2011-01-15 Injury None None
2011-01-11 Injury None None
2011-01-03 Injury None None
2010-12-29 Injury None None
2010-12-22 Injury None None
2010-12-13 Injury None None
2010-11-30 Malfunction None None
2010-11-30 Injury None None
2010-11-23 Injury None None
2010-11-15 Death None None
2010-11-10 Unknown None None
2010-11-10 Unknown None None
2010-11-10 Unknown None None
2010-10-29 Injury None None
2010-10-28 Injury None None
2010-10-27 Injury None None
2010-10-20 Injury None None
2010-10-11 Malfunction None None
2010-10-07 Injury None None
2010-09-28 Death None None
2010-09-13 Malfunction None None
2010-09-10 Injury None None
2010-09-10 Injury None None
2010-09-07 Injury None None
2010-09-07 Injury None None
2010-08-31 Injury None None
2010-08-27 Injury None None
2010-08-24 Injury None None
2010-08-18 Malfunction None None
2010-08-05 Injury None None
2010-08-04 Injury None None
2010-07-23 Injury None None
2010-07-12 Injury None None
2010-07-02 Injury None None
2010-06-26 Death None None