QUADRA ASSURA DDQP+

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 - NEUROMODULATION (PUERTO RICO ), ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION.

The following problems were reported about this device:

Date Event Type Patient Problem Device Problem
2019-09-19 Injury None High impedance
2019-09-16 Injury None Premature Discharge of Battery, Battery Problem
2019-09-09 Malfunction None Over-Sensing
2019-08-15 Injury None Premature Discharge of Battery
2019-08-14 Malfunction None Over-Sensing
2019-07-29 Injury None Premature Discharge of Battery, Failure to Interrogate
2019-07-18 Malfunction None Over-Sensing
2019-06-27 Malfunction None Over-Sensing
2019-06-21 Injury None Battery Problem
2019-06-14 Death None Adverse Event Without Identified Device or Use Problem
2019-06-11 Injury None Battery Problem
2019-06-06 Injury None Inappropriate/Inadequate Shock/Stimulation
2019-05-21 Malfunction None Over-Sensing
2019-05-08 Malfunction None Misconnection
2019-05-07 Malfunction None Over-Sensing
2019-04-29 Injury None Battery Problem
2019-04-23 Injury None Battery Problem
2019-04-17 Injury None Battery Problem
2019-04-15 Malfunction None Communication or Transmission Problem, Inappropriate or Unexpected Reset
2019-04-03 Malfunction None Over-Sensing
2019-02-04 Malfunction None Battery Problem
2019-01-23 Injury None Premature Discharge of Battery, Battery Problem
2019-01-15 Injury None Battery Problem
2019-01-06 Injury None Battery Problem
2019-01-03 Injury None Battery Problem
2018-12-12 Malfunction None Over-Sensing
2018-12-12 Injury None Battery Problem
2018-12-08 Injury None Battery Problem
2018-11-21 Injury None Signal Artifact/Noise, Inappropriate/Inadequate Shock/Stimulation
2018-11-19 Malfunction None Over-Sensing
2018-11-15 Malfunction None Over-Sensing
2018-11-08 Malfunction None Over-Sensing
2018-11-05 Injury None Battery Problem
2018-10-31 Malfunction None Over-Sensing
2018-10-29 Malfunction None Inappropriate or Unexpected Reset
2018-10-23 Injury None Adverse Event Without Identified Device or Use Problem
2018-10-19 Injury None Battery Problem
2018-10-18 Malfunction None Under-Sensing
2018-10-16 Injury None Battery Problem
2018-10-02 Injury None Battery Problem
2018-09-29 Injury None Inappropriate/Inadequate Shock/Stimulation
2018-09-27 Injury None Adverse Event Without Identified Device or Use Problem
2018-09-25 Malfunction None Battery Problem
2018-09-24 Malfunction None Battery Problem
2018-09-23 Malfunction None Over-Sensing
2018-09-19 Malfunction None Signal Artifact/Noise, Over-Sensing
2018-09-18 Injury None Battery Problem
2018-09-18 Injury None Adverse Event Without Identified Device or Use Problem
2018-09-17 Injury None Inappropriate or Unexpected Reset
2018-09-10 Injury None Adverse Event Without Identified Device or Use Problem
2018-09-07 Malfunction None Over-Sensing
2018-08-23 Injury None High impedance
2018-08-22 Malfunction None Over-Sensing
2018-08-04 Injury None Battery Problem
2018-07-24 Injury None Battery Problem
2018-07-19 Injury None Adverse Event Without Identified Device or Use Problem
2018-07-19 Injury None Premature Discharge of Battery
2018-07-17 Injury None Adverse Event Without Identified Device or Use Problem
2018-07-13 Malfunction None Over-Sensing
2018-07-08 Injury None Adverse Event Without Identified Device or Use Problem
2018-07-07 Injury None Battery Problem
2018-07-05 Injury None Adverse Event Without Identified Device or Use Problem
2018-07-03 Injury None Premature Discharge of Battery, Failure to Interrogate
2018-06-30 Injury None Incorrect Interpretation of Signal, Inappropriate/Inadequate Shock/Stimulation
2018-06-28 Injury None Adverse Event Without Identified Device or Use Problem
2018-06-28 Injury None Battery Problem
2018-06-21 Injury None Battery Problem
2018-06-18 Injury None Adverse Event Without Identified Device or Use Problem
2018-06-07 Injury None Inappropriate/Inadequate Shock/Stimulation, Programming Issue
2018-06-05 Injury None Battery Problem
2018-05-22 Injury None Battery Problem
2018-05-22 Injury None Premature Discharge of Battery
2018-05-21 Malfunction None Over-Sensing
2018-05-16 Malfunction None Failure to Interrogate
2018-05-02 Injury None Inappropriate or Unexpected Reset
2018-04-23 Injury None Premature Discharge of Battery, Failure to Interrogate
2018-04-16 Injury None Battery Problem
2018-04-11 Malfunction None Over-Sensing
2018-04-06 Injury None Adverse Event Without Identified Device or Use Problem
2018-03-29 Malfunction None Failure to Deliver Shock/Stimulation, Inappropriate or Unexpected Reset
2018-03-28 Injury None Battery Problem
2018-03-28 Injury None Failure to Interrogate
2018-03-26 Injury None Adverse Event Without Identified Device or Use Problem
2018-03-13 Injury None Battery Problem
2018-03-02 Malfunction None Over-Sensing
2018-02-20 Malfunction None Over-Sensing
2018-02-07 Malfunction None Over-Sensing
2018-02-01 Malfunction None Communication or Transmission Problem, Inappropriate or Unexpected Reset
2018-01-31 Malfunction None Over-Sensing
2018-01-29 Injury None Adverse Event Without Identified Device or Use Problem
2018-01-29 Injury None Battery Problem
2018-01-23 Injury None Adverse Event Without Identified Device or Use Problem
2018-01-18 Malfunction None Inappropriate or Unexpected Reset
2018-01-16 Malfunction None Over-Sensing
2018-01-09 Injury None Battery Problem
2018-01-08 Malfunction None Under-Sensing
2018-01-05 Injury None Battery Problem
2018-01-02 Malfunction None Over-Sensing
2018-01-01 Malfunction None Over-Sensing
2017-12-26 Malfunction None Over-Sensing
2017-12-26 Malfunction None Inappropriate or Unexpected Reset
2017-12-21 Malfunction None Signal Artifact/Noise
2017-12-20 Injury None Adverse Event Without Identified Device or Use Problem
2017-12-19 Malfunction None Over-Sensing
2017-12-13 Malfunction None Communication or Transmission Problem
2017-12-08 Malfunction None Over-Sensing
2017-12-08 Malfunction None Over-Sensing
2017-12-05 Injury None Battery Problem
2017-12-05 Injury None Battery Problem
2017-12-04 Injury None Battery Problem
2017-11-24 Malfunction None Communication or Transmission Problem, Inappropriate or Unexpected Reset
2017-11-19 Injury None Battery Problem
2017-11-18 Malfunction None Over-Sensing
2017-11-17 Injury None Adverse Event Without Identified Device or Use Problem
2017-11-16 Malfunction None Over-Sensing
2017-11-10 Injury None Adverse Event Without Identified Device or Use Problem
2017-11-09 Malfunction None Incorrect Measurement
2017-11-08 Injury None Adverse Event Without Identified Device or Use Problem
2017-11-07 Malfunction None Over-Sensing
2017-11-06 Malfunction None Over-Sensing
2017-11-04 Malfunction None Signal Artifact/Noise, Over-Sensing
2017-11-02 Injury None Adverse Event Without Identified Device or Use Problem
2017-11-01 Injury None Adverse Event Without Identified Device or Use Problem
2017-10-27 Malfunction None Device Alarm System
2017-10-27 Malfunction None Over-Sensing
2017-10-25 Malfunction None Over-Sensing
2017-10-24 Malfunction None Over-Sensing
2017-10-19 Malfunction None Inappropriate or Unexpected Reset
2017-10-18 Malfunction None Over-Sensing
2017-10-16 Injury None Premature Discharge of Battery, Failure to Interrogate
2017-10-10 Injury None Adverse Event Without Identified Device or Use Problem
2017-10-08 Malfunction None Over-Sensing
2017-10-06 Malfunction None Over-Sensing
2017-10-03 Malfunction None Over-Sensing
2017-10-03 Malfunction None Over-Sensing
2017-09-28 Malfunction None Over-Sensing
2017-09-27 Malfunction None Over-Sensing
2017-09-26 Injury None Inappropriate/Inadequate Shock/Stimulation
2017-09-22 Malfunction None Over-Sensing
2017-09-22 Malfunction None Over-Sensing
2017-09-21 Injury None Premature Discharge of Battery
2017-09-20 Malfunction None Over-Sensing
2017-09-18 Malfunction None Incorrect Interpretation of Signal
2017-09-18 Injury None Premature Discharge of Battery
2017-09-12 Malfunction None Over-Sensing
2017-09-12 Malfunction None Over-Sensing
2017-09-09 Malfunction None Over-Sensing
2017-09-08 Injury None Premature Discharge of Battery
2017-09-05 Malfunction None Defibrillation/Stimulation Problem
2017-08-25 Malfunction None Over-Sensing
2017-08-24 Injury None Device Alarm System, Premature Discharge of Battery
2017-08-22 Injury None Premature Discharge of Battery
2017-08-16 Malfunction None Over-Sensing
2017-08-14 Malfunction None Premature Discharge of Battery
2017-08-13 Malfunction None Communication or Transmission Problem, Inappropriate or Unexpected Reset
2017-08-11 Malfunction None Over-Sensing
2017-07-20 Injury None Adverse Event Without Identified Device or Use Problem
2017-07-13 Injury None Adverse Event Without Identified Device or Use Problem
2017-07-12 Injury None Premature Discharge of Battery
2017-07-07 Malfunction None Over-Sensing
2017-07-06 Injury None Signal Artifact/Noise, Over-Sensing
2017-07-05 Injury None Adverse Event Without Identified Device or Use Problem
2017-07-05 Malfunction None Over-Sensing
2017-07-05 Malfunction None Over-Sensing, Device Sensing Problem
2017-06-29 Malfunction None Over-Sensing
2017-06-26 Malfunction None Over-Sensing
2017-06-16 Malfunction None Over-Sensing
2017-06-06 Injury None Adverse Event Without Identified Device or Use Problem
2017-06-05 Injury None Premature Discharge of Battery, Adverse Event Without Identified Device or Use Problem
2017-06-01 Injury None Premature Discharge of Battery, Inappropriate or Unexpected Reset
2017-05-29 Malfunction None Over-Sensing
2017-05-23 Malfunction None Over-Sensing
2017-05-16 Malfunction None Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2017-05-15 Malfunction None Over-Sensing
2017-05-15 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-14 Malfunction None Over-Sensing
2017-05-10 Malfunction None Over-Sensing
2017-05-08 Malfunction None Over-Sensing
2017-05-01 Injury None Adverse Event Without Identified Device or Use Problem
2017-05-01 Malfunction None Over-Sensing
2017-04-28 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-26 Malfunction None Over-Sensing
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
2017-04-24 Malfunction None Inappropriate or Unexpected Reset
2017-04-21 Malfunction None Over-Sensing
2017-04-20 Malfunction None Over-Sensing
2017-04-20 Malfunction None Over-Sensing
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
2017-04-10 Injury None Adverse Event Without Identified Device or Use Problem
2017-04-07 Injury None Premature Discharge of Battery
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
2017-04-02 Malfunction None Over-Sensing
2017-03-31 Malfunction None Over-Sensing
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
2017-03-27 Death 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 Malfunction None Over-Sensing
2017-03-23 Malfunction None Over-Sensing
2017-03-23 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-20 Malfunction None Over-Sensing
2017-03-20 Injury None Premature Discharge of Battery
2017-03-20 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
2017-03-15 Malfunction None Over-Sensing
2017-03-13 Malfunction None Inappropriate or Unexpected Reset
2017-03-10 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-08 Injury None Premature Discharge of Battery, Low impedance, Delayed Charge Time
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 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-02 Injury None Adverse Event Without Identified Device or Use Problem
2017-03-01 Malfunction None Over-Sensing
2017-02-27 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-24 Injury None Adverse Event Without Identified Device or Use Problem
2017-02-22 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 Malfunction None Over-Sensing
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
2017-02-16 Malfunction None Over-Sensing
2017-02-16 Malfunction None Over-Sensing
2017-02-08 Injury None Premature Discharge of Battery
2017-02-07 Malfunction None Over-Sensing
2017-02-02 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 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
2017-01-27 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
2017-01-25 Malfunction None High impedance
2017-01-21 Malfunction None Over-Sensing
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
2017-01-18 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
2017-01-13 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-12 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-11 Malfunction None Over-Sensing
2017-01-11 Injury None Adverse Event Without Identified Device or Use Problem
2017-01-06 Malfunction None Over-Sensing
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 Malfunction None Break
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
2017-01-02 Injury None Over-Sensing, Failure to Analyze Signal
2017-01-01 Death 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 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 Malfunction None Over-Sensing
2016-12-22 Injury None Adverse Event Without Identified Device or Use Problem
2016-12-21 Malfunction None Pacemaker Found in Back-Up Mode
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 Malfunction None Over-Sensing
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
2016-12-15 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 Device Alarm System
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
2016-12-13 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
2016-12-09 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 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 Device Alarm System
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 Vibration
2016-12-06 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 Malfunction None Over-Sensing
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
2016-11-29 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
2016-11-25 Injury None Adverse Event Without Identified Device or Use Problem
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
2016-11-24 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-24 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-24 Death None Defibrillation/Stimulation 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
2016-11-22 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 Malfunction None Over-Sensing
2016-11-22 Malfunction None Over-Sensing
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 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 Malfunction None Delayed Charge Time
2016-11-17 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-17 Injury None Device Alarm System
2016-11-16 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-16 Malfunction None Over-Sensing
2016-11-16 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-15 Malfunction None Over-Sensing
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 Malfunction None Over-Sensing
2016-11-14 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
2016-11-09 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
2016-11-07 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
2016-11-05 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 Malfunction None Over-Sensing
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
2016-11-02 Injury None Device Operates Differently Than Expected
2016-11-02 Injury None Adverse Event Without Identified Device or Use Problem
2016-11-01 Malfunction None Over-Sensing
2016-10-31 Malfunction None Over-Sensing
2016-10-27 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 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-20 Malfunction None Over-Sensing
2016-10-20 Malfunction None Over-Sensing
2016-10-20 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-17 Injury None Adverse Event Without Identified Device or Use Problem
2016-10-13 Malfunction None Over-Sensing
2016-10-12 Injury None Nonstandard Device, Adverse Event Without Identified Device or Use Problem
2016-09-29 Malfunction None Over-Sensing
2016-09-29 Malfunction None Over-Sensing
2016-09-28 Malfunction None Over-Sensing
2016-09-16 Malfunction None Over-Sensing, Device Operates Differently Than Expected
2016-09-15 Injury None Defibrillation/Stimulation Problem, Inappropriate or Unexpected Reset, Output Problem
2016-09-10 Malfunction None Over-Sensing, Device Operates Differently Than Expected
2016-09-05 Malfunction None Inappropriate or Unexpected Reset
2016-08-25 Malfunction None Over-Sensing
2016-08-19 Injury None Delayed Charge Time, Noise, Audible
2016-08-17 Injury None Adverse Event Without Identified Device or Use Problem
2016-08-09 Malfunction None Over-Sensing
2016-08-09 Malfunction None Over-Sensing
2016-07-28 Injury None Premature Discharge of Battery, Difficult to Interrogate, Pacing Problem, Material Deformation
2016-07-28 Malfunction None Over-Sensing, Device Operates Differently Than Expected
2016-07-19 Malfunction None Over-Sensing
2016-07-13 Malfunction None Over-Sensing
2016-07-11 Malfunction None Over-Sensing
2016-06-21 Malfunction None Over-Sensing
2016-06-02 Injury None Over-Sensing, Low impedance, Connection Problem, Inappropriate or Unexpected Reset
2016-04-22 Malfunction None Over-Sensing
2015-12-12 Malfunction None Over-Sensing
2015-04-22 Malfunction None Over-Sensing
2015-04-16 Malfunction None Over-Sensing
2015-04-15 Malfunction None Over-Sensing
2015-04-09 Malfunction None Failure to Interrogate
2015-04-08 Malfunction None Device Sensing Problem
2015-04-07 Malfunction None Over-Sensing
2015-04-06 Malfunction None Over-Sensing
2015-04-01 Injury None Failure to Interrogate
2015-03-31 Malfunction None Device Operates Differently Than Expected
2015-03-16 Malfunction None Over-Sensing
2015-03-05 Malfunction None Over-Sensing
2015-03-05 Malfunction None Over-Sensing
2015-03-01 Malfunction None Over-Sensing
2015-02-11 Malfunction None Over-Sensing
2015-02-10 Malfunction None Over-Sensing
2015-02-05 Malfunction None Over-Sensing
2014-12-11 Malfunction None Over-Sensing
2014-07-24 Malfunction None Over-Sensing, Device Operates Differently Than Expected
2014-07-03 Malfunction None Over-Sensing
2014-06-24 Malfunction None Over-Sensing
2014-06-18 Malfunction None Over-Sensing
2014-06-13 Malfunction None Over-Sensing
2014-06-11 Malfunction None Connection Problem
2014-06-04 Malfunction None Over-Sensing
2014-06-04 Malfunction None Over-Sensing
2014-06-03 Malfunction None Over-Sensing
2014-05-28 Injury None Inappropriate/Inadequate Shock/Stimulation
2014-05-24 Malfunction None Over-Sensing
2014-05-24 Malfunction None Over-Sensing
2014-05-23 Malfunction None Over-Sensing
2014-05-23 Malfunction None Over-Sensing
2014-05-23 Injury None High impedance, Loose or Intermittent Connection, Over-Sensing
2014-05-22 Malfunction None Over-Sensing
2014-05-21 Injury None Inappropriate/Inadequate Shock/Stimulation
2014-05-21 Malfunction None Over-Sensing
2014-05-20 Malfunction None Over-Sensing
2014-05-19 Injury None Failure to Interrogate, Inappropriate/Inadequate Shock/Stimulation, Inappropriate or Unexpected Reset
2014-05-18 Malfunction None Over-Sensing
2014-05-17 Injury None Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2014-05-15 Malfunction None Connection Problem
2014-05-13 Malfunction None Over-Sensing
2014-05-12 Malfunction None Over-Sensing
2014-05-12 Malfunction None Device Operates Differently Than Expected
2014-05-09 Malfunction None Over-Sensing
2014-05-05 Injury None Adverse Event Without Identified Device or Use Problem
2014-05-02 Malfunction None Over-Sensing
2014-04-30 Injury None Migration or Expulsion of Device
2014-04-30 Malfunction None Over-Sensing
2014-04-28 Injury None Inappropriate/Inadequate Shock/Stimulation
2014-04-26 Malfunction None Over-Sensing
2014-04-25 Malfunction None Over-Sensing, Device Operates Differently Than Expected
2014-04-23 Malfunction None Over-Sensing
2014-04-19 Malfunction None Over-Sensing, Pacing Problem
2014-04-15 Malfunction None Over-Sensing
2014-04-15 Malfunction None Over-Sensing
2014-04-15 Injury None Adverse Event Without Identified Device or Use Problem
2014-04-12 Death None Adverse Event Without Identified Device or Use Problem
2014-04-10 Injury None Adverse Event Without Identified Device or Use Problem
2014-04-08 Malfunction None Over-Sensing
2014-04-04 Malfunction None Over-Sensing, Device Operates Differently Than Expected
2014-03-31 Malfunction None Over-Sensing
2014-03-28 Malfunction None Over-Sensing
2014-03-26 Malfunction None Over-Sensing
2014-03-25 Malfunction None Over-Sensing
2014-03-25 Malfunction None Over-Sensing
2014-03-25 Injury None Adverse Event Without Identified Device or Use Problem
2014-03-19 Malfunction None Device Operates Differently Than Expected
2014-03-17 Malfunction None Over-Sensing
2014-03-17 Malfunction None Over-Sensing
2014-03-14 Malfunction None Over-Sensing
2014-03-13 Injury None Failure to Interrogate, Inappropriate/Inadequate Shock/Stimulation, Inappropriate or Unexpected Reset
2014-03-13 Malfunction None Under-Sensing, Device Operates Differently Than Expected
2014-03-11 Injury None Adverse Event Without Identified Device or Use Problem
2014-03-10 Malfunction None Over-Sensing
2014-03-10 Malfunction None High impedance, Connection Problem
2014-03-01 Malfunction None Under-Sensing
2014-02-28 Malfunction None Over-Sensing
2014-02-27 Malfunction None Over-Sensing
2014-02-24 Malfunction None Over-Sensing
2014-02-23 Malfunction None Over-Sensing, Device Operates Differently Than Expected
2014-02-17 Malfunction None Device Operates Differently Than Expected
2014-02-13 Malfunction None Electromagnetic Interference, Device Operates Differently Than Expected
2014-02-12 Malfunction None Over-Sensing
2014-02-11 Malfunction None Over-Sensing
2014-02-06 Malfunction None Device Operates Differently Than Expected
2014-02-05 Injury None Inappropriate/Inadequate Shock/Stimulation
2014-02-05 Malfunction None Over-Sensing
2014-01-29 Malfunction None Over-Sensing
2014-01-27 Malfunction None Over-Sensing
2014-01-24 Injury None Adverse Event Without Identified Device or Use Problem
2014-01-24 Malfunction None Over-Sensing
2014-01-23 Malfunction None Over-Sensing
2014-01-22 Malfunction None Over-Sensing
2014-01-20 Malfunction None Over-Sensing
2014-01-20 Injury None Inappropriate/Inadequate Shock/Stimulation, Inappropriate or Unexpected Reset
2014-01-17 Malfunction None Over-Sensing
2014-01-15 Malfunction None Over-Sensing
2014-01-14 Injury None Inappropriate/Inadequate Shock/Stimulation, Output Problem
2014-01-13 Malfunction None Over-Sensing, Device Operates Differently Than Expected
2014-01-07 Malfunction None Over-Sensing
2014-01-05 Malfunction None Over-Sensing
2014-01-05 Malfunction None Over-Sensing
2014-01-03 Malfunction None Over-Sensing
2013-12-30 Malfunction None Over-Sensing
2013-12-29 Malfunction None Over-Sensing
2013-12-27 Malfunction None Over-Sensing
2013-12-24 Malfunction None Over-Sensing
2013-12-24 Malfunction None Over-Sensing
2013-12-18 Injury None Failure to Convert Rhythm, Device Operates Differently Than Expected
2013-12-17 Malfunction None Premature Discharge of Battery
2013-12-17 Malfunction None Over-Sensing
2013-12-16 Malfunction None Over-Sensing
2013-12-11 Malfunction None None
2013-12-11 Malfunction None Over-Sensing
2013-12-09 Injury None Adverse Event Without Identified Device or Use Problem
2013-12-09 Malfunction None Over-Sensing
2013-12-08 Malfunction None Inappropriate or Unexpected Reset
2013-12-06 Injury None Connection Problem
2013-12-04 Malfunction None Over-Sensing
2013-12-03 Malfunction None Over-Sensing
2013-12-03 Malfunction None Over-Sensing
2013-12-02 Malfunction None Over-Sensing
2013-12-02 Malfunction None Failure to Analyze Signal
2013-12-02 Malfunction None False Alarm, Over-Sensing
2013-12-01 Death None None
2013-11-29 Malfunction None None
2013-11-28 Malfunction None None
2013-11-25 Malfunction None None
2013-11-22 Malfunction None None
2013-11-22 Malfunction None Over-Sensing
2013-11-22 Malfunction None Failure to Sense, Low impedance
2013-11-20 Malfunction None None
2013-11-20 Malfunction None None
2013-11-18 Malfunction None Over-Sensing
2013-11-18 Malfunction None Over-Sensing
2013-11-16 Malfunction None None
2013-11-13 Malfunction None None
2013-11-12 Malfunction None Over-Sensing
2013-11-11 Malfunction None None
2013-11-06 Injury None None
2013-11-05 Malfunction None Over-Sensing
2013-11-05 Malfunction None Over-Sensing
2013-11-05 Malfunction None None
2013-11-04 Injury None Adverse Event Without Identified Device or Use Problem
2013-11-04 Injury None Inappropriate/Inadequate Shock/Stimulation
2013-11-04 Malfunction None None
2013-11-01 Malfunction None Over-Sensing
2013-10-31 Malfunction None None
2013-10-26 Malfunction None Device Operates Differently Than Expected
2013-10-24 Malfunction None None
2013-10-11 Malfunction None None
2013-10-09 Malfunction None None
2013-10-06 Malfunction None Loss of Data
2013-10-04 Injury None None
2013-10-03 Malfunction None None
2013-10-02 Injury None None
2013-09-30 Malfunction None None
2013-09-30 Malfunction None None
2013-09-29 Malfunction None None
2013-09-27 Malfunction None None
2013-09-27 Malfunction None None
2013-09-25 Malfunction None None
2013-09-20 Injury None None
2013-09-19 Injury None Adverse Event Without Identified Device or Use Problem
2013-09-19 Malfunction None None
2013-09-18 Malfunction None None
2013-09-17 Malfunction None None
2013-09-13 Malfunction None None
2013-09-12 Malfunction None None
2013-09-10 Malfunction None None
2013-09-09 Malfunction None None
2013-09-09 Injury None None
2013-09-07 Injury None None
2013-09-06 Injury None None
2013-09-04 Malfunction None None
2013-09-03 Malfunction None None
2013-09-03 Malfunction None None
2013-09-03 Malfunction None None
2013-08-30 Malfunction None None
2013-08-29 Malfunction None None
2013-08-29 Malfunction None None
2013-08-28 Malfunction None None
2013-08-28 Malfunction None None
2013-08-27 Injury None None
2013-08-15 Injury None None
2013-08-15 Malfunction None None
2013-08-12 Injury None None
2013-08-01 Malfunction None None
2013-08-01 Malfunction None None
2013-07-31 Malfunction None None
2013-07-30 Injury None None
2013-07-29 Malfunction None None
2013-07-24 Malfunction None None
2013-07-23 Malfunction None None
2013-07-22 Malfunction None None
2013-07-22 Malfunction None None
2013-07-19 Injury None None
2013-07-19 Malfunction None None
2013-07-18 Malfunction None None
2013-07-17 Malfunction None None
2013-07-17 Injury None None
2013-07-16 Malfunction None None
2013-07-15 Malfunction None None
2013-07-10 Malfunction None None
2013-07-09 Malfunction None None
2013-07-06 Malfunction None None
2013-07-03 Malfunction None None
2013-07-01 Malfunction None None
2013-06-28 Malfunction None None
2013-06-25 Malfunction None None
2013-06-24 Malfunction None None
2013-06-24 Malfunction None None
2013-06-20 Malfunction None None
2013-06-20 Malfunction None None
2013-06-19 Malfunction None None
2013-06-19 Malfunction None None
2013-06-19 Malfunction None None
2013-06-19 Injury None None
2013-06-18 Injury None None
2013-06-17 Malfunction None None
2013-06-13 Malfunction None None
2013-06-12 Malfunction None None
2013-06-10 Malfunction None None
2013-06-10 Malfunction None None
2013-06-09 Malfunction None None
2013-06-06 Malfunction None None
2013-06-06 Malfunction None None
2013-06-05 Malfunction None None
2013-06-04 Malfunction None None
2013-05-30 Malfunction None None
2013-05-30 Malfunction None None
2013-05-29 Malfunction None None
2013-05-29 Malfunction None None
2013-05-28 Injury None None
2013-05-24 Injury None None
2013-05-23 Malfunction None None
2013-05-22 Malfunction None None
2013-05-17 Injury None None
2013-05-17 Malfunction None None
2013-05-13 Malfunction None None
2013-05-13 Injury None None
2013-05-08 Malfunction None None
2013-05-08 Malfunction None None
2013-05-07 Malfunction None None
2013-05-06 Injury None None
2013-05-01 Malfunction None None
2013-04-29 Malfunction None None
2013-04-29 Malfunction None None
2013-04-24 Malfunction None None
2013-04-23 Malfunction None None
2013-04-16 Malfunction None None
2013-04-12 Malfunction None None
2013-04-11 Malfunction None None
2013-04-11 Malfunction None None
2013-04-09 Malfunction None None
2013-04-09 Malfunction None None
2013-04-05 Malfunction None None
2013-04-04 Malfunction None None
2013-04-03 Death None None
2013-03-26 Injury None None
2013-03-25 Malfunction None None
2013-03-14 Malfunction None None
2013-03-13 Malfunction None None
2013-03-13 Malfunction None None
2013-03-12 Malfunction None None
2013-03-11 Malfunction None None
2013-03-07 Malfunction None None
2013-03-07 Malfunction None None
2013-03-06 Malfunction None None
2013-03-04 Injury None None
2013-02-26 Malfunction None None
2013-02-25 Malfunction None None
2013-02-25 Malfunction None None
2013-02-20 Injury None None
2013-02-19 Malfunction None None
2013-02-19 Malfunction None None
2013-02-15 Malfunction None None
2013-02-14 Malfunction None None
2013-02-11 Malfunction None None
2013-02-06 Injury None None
2013-02-06 Malfunction None None
2013-02-05 Malfunction None None
2013-02-04 Malfunction None None
2013-01-12 Malfunction None None
2013-01-10 Malfunction None Over-Sensing
2013-01-07 Malfunction None None
2013-01-07 Malfunction None None
2012-12-31 Malfunction None None
2012-11-08 Malfunction None Over-Sensing
2012-09-26 Malfunction None Over-Sensing
2012-08-23 Malfunction None Over-Sensing
2012-05-30 Malfunction None Premature Discharge of Battery
2012-04-25 Malfunction None Over-Sensing