FORTIFY VR, U1.6 SJ4 US

IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

This device is manufactured by 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, ST JUDE MEDICAL CARDIOLOGY DIVISION.

The following problems were reported about this device:

Date	Event Type	Patient Problem	Device Problem
2024-05-15	Injury	Arrhythmia	Failure to Convert Rhythm, Inappropriate or Unexpected Reset
2024-05-02	Injury	No Clinical Signs, Symptoms or Conditions	Premature Discharge of Battery
2024-04-17	Injury	Discomfort	Adverse Event Without Identified Device or Use Problem
2024-04-09	Injury	No Clinical Signs, Symptoms or Conditions	Premature Discharge of Battery
2024-01-23	Malfunction	No Clinical Signs, Symptoms or Conditions	Failure to Interrogate
2023-10-13	Injury	Arrhythmia	Failure to Convert Rhythm, Inappropriate or Unexpected Reset
2023-07-28	Injury	No Clinical Signs, Symptoms or Conditions	Premature Discharge of Battery
2023-07-12	Malfunction	No Clinical Signs, Symptoms or Conditions	Environmental Compatibility Problem, Inappropriate or Unexpected Reset
2023-06-05	Injury	No Clinical Signs, Symptoms or Conditions	Premature Discharge of Battery
2023-04-10	Injury	No Clinical Signs, Symptoms or Conditions	Premature Discharge of Battery
2023-02-05	Injury	Discomfort	Incorrect Interpretation of Signal, Inappropriate/Inadequate Shock/Stimulation
2023-02-03	Injury	No Clinical Signs, Symptoms or Conditions	Premature Discharge of Battery
2023-01-22	Injury	No Clinical Signs, Symptoms or Conditions	Premature Discharge of Battery
2023-01-04	Injury	Unspecified Infection	Adverse Event Without Identified Device or Use Problem
2023-01-03	Injury	No Clinical Signs, Symptoms or Conditions	Premature Discharge of Battery
2022-12-12	Injury	Fever, Unspecified Infection, Pocket Erosion	Adverse Event Without Identified Device or Use Problem
2022-12-04	Injury	No Clinical Signs, Symptoms or Conditions	Premature Discharge of Battery
2022-10-01	Injury	Failure of Implant, Nerve Damage, Anxiety, Shock from Patient Lead(s), Muscle/Tendon Damage	None
2022-09-29	Injury	None	Incorrect Interpretation of Signal, Inappropriate/Inadequate Shock/Stimulation
2022-09-12	Malfunction	None	Premature Discharge of Battery
2022-09-08	Injury	None	Premature Discharge of Battery
2022-08-09	Injury	None	Premature Discharge of Battery
2022-04-11	Injury	None	Premature Discharge of Battery
2022-04-05	Injury	None	Premature Discharge of Battery
2022-03-31	Injury	None	Premature Discharge of Battery
2022-03-19	Injury	None	Premature Discharge of Battery
2022-03-17	Injury	None	Premature Discharge of Battery
2022-03-16	Injury	None	Premature Discharge of Battery
2022-03-11	Malfunction	None	Premature Discharge of Battery
2019-09-13	Injury	None	Battery Problem
2019-08-31	Injury	None	Inappropriate/Inadequate Shock/Stimulation, Data Problem
2019-08-29	Injury	None	Battery Problem
2019-08-27	Injury	None	Premature Discharge of Battery, Battery Problem
2019-08-26	Injury	None	Battery Problem
2019-08-26	Injury	None	Battery Problem
2019-08-23	Injury	None	Battery Problem
2019-08-17	Injury	None	Battery Problem
2019-08-15	Injury	None	Premature Discharge of Battery, Failure to Interrogate, Telemetry Discrepancy
2019-08-14	Malfunction	None	Battery Problem
2019-08-07	Injury	None	Battery Problem
2019-08-07	Malfunction	None	Battery Problem
2019-08-05	Injury	None	Adverse Event Without Identified Device or Use Problem
2019-07-29	Malfunction	None	Failure to Charge, Delayed Charge Time
2019-07-24	Injury	None	Battery Problem
2019-07-24	Injury	None	Battery Problem
2019-07-19	Injury	None	Delayed Charge Time
2019-07-12	Injury	None	Battery Problem
2019-07-09	Injury	None	Battery Problem
2019-07-06	Injury	None	Battery Problem
2019-07-05	Injury	None	Battery Problem
2019-07-03	Injury	None	Battery Problem
2019-07-03	Injury	None	Battery Problem
2019-07-02	Injury	None	Inappropriate/Inadequate Shock/Stimulation, Data Problem
2019-07-02	Injury	None	Premature Discharge of Battery, Battery Problem
2019-06-28	Injury	None	Battery Problem
2019-06-24	Injury	None	Premature Discharge of Battery, Battery Problem
2019-06-24	Malfunction	None	High impedance
2019-06-19	Injury	None	Battery Problem
2019-06-18	Injury	None	Battery Problem
2019-06-14	Injury	None	Battery Problem
2019-06-14	Injury	None	Failure to Deliver Shock/Stimulation, Incorrect Interpretation of Signal, Inappropriate/Inadequate Shock/Stimulation
2019-06-14	Injury	None	Inappropriate/Inadequate Shock/Stimulation, Under-Sensing
2019-06-05	Injury	None	Premature Discharge of Battery, Battery Problem
2019-05-30	Injury	None	Battery Problem
2019-05-29	Injury	None	Premature Discharge of Battery, Battery Problem
2019-05-24	Injury	None	Battery Problem
2019-05-23	Injury	None	Battery Problem
2019-05-22	Injury	None	Premature Discharge of Battery, Failure to Interrogate, Battery Problem, Appropriate Term/Code Not Available
2019-05-20	Injury	None	Battery Problem
2019-05-17	Injury	None	Battery Problem
2019-05-16	Injury	None	Delayed Charge Time
2019-05-15	Injury	None	Battery Problem
2019-05-11	Injury	None	Battery Problem
2019-05-09	Injury	None	Battery Problem
2019-05-07	Injury	None	Battery Problem
2019-05-05	Malfunction	None	Battery Problem
2019-05-03	Injury	None	Battery Problem
2019-05-01	Injury	None	Battery Problem
2019-04-30	Injury	None	Premature Discharge of Battery, Battery Problem
2019-04-26	Injury	None	Battery Problem
2019-04-26	Injury	None	Migration or Expulsion of Device
2019-04-23	Injury	None	Premature Discharge of Battery, Battery Problem
2019-04-22	Injury	None	Premature Discharge of Battery, Failure to Interrogate
2019-04-18	Injury	None	Premature Elective Replacement Indicator
2019-04-17	Malfunction	None	Battery Problem
2019-04-12	Injury	None	Battery Problem
2019-04-10	Injury	None	Battery Problem
2019-04-10	Injury	None	Incorrect Interpretation of Signal, Inappropriate/Inadequate Shock/Stimulation
2019-04-09	Injury	None	Battery Problem
2019-04-05	Injury	None	Adverse Event Without Identified Device or Use Problem
2019-04-04	Injury	None	Battery Problem
2019-04-03	Injury	None	Battery Problem
2019-03-31	Injury	None	Battery Problem
2019-03-29	Injury	None	Battery Problem
2019-03-28	Injury	None	Adverse Event Without Identified Device or Use Problem
2019-03-28	Malfunction	None	Under-Sensing
2019-03-27	Injury	None	Battery Problem
2019-03-26	Injury	None	Battery Problem
2019-03-25	Malfunction	None	Battery Problem
2019-03-25	Injury	None	Battery Problem
2019-03-18	Injury	None	Inappropriate/Inadequate Shock/Stimulation, Inappropriate or Unexpected Reset, Data Problem
2019-03-17	Injury	None	Adverse Event Without Identified Device or Use Problem
2019-03-15	Injury	None	Failure to Interrogate
2019-03-12	Injury	None	Battery Problem
2019-03-12	Injury	None	Incorrect Interpretation of Signal, Inappropriate/Inadequate Shock/Stimulation
2019-03-11	Injury	None	Battery Problem
2019-03-08	Injury	None	Signal Artifact/Noise, Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2019-03-07	Injury	None	Battery Problem
2019-03-06	Death	None	Failure to Deliver Shock/Stimulation, Incorrect Interpretation of Signal, Under-Sensing
2019-03-04	Injury	None	Battery Problem
2019-03-04	Injury	None	Battery Problem
2019-03-04	Injury	None	Premature Discharge of Battery, Failure to Interrogate, Battery Problem
2019-03-01	Injury	None	Battery Problem
2019-02-28	Injury	None	Battery Problem
2019-02-27	Malfunction	None	Incorrect Measurement
2019-02-26	Injury	None	Premature Discharge of Battery, Failure to Interrogate, No Device Output
2019-02-26	Injury	None	Premature Discharge of Battery, Failure to Interrogate
2019-02-25	Injury	None	Battery Problem
2019-02-21	Injury	None	Adverse Event Without Identified Device or Use Problem
2019-02-21	Injury	None	Battery Problem
2019-02-20	Injury	None	Inappropriate/Inadequate Shock/Stimulation
2019-02-17	Injury	None	Battery Problem
2019-02-16	Injury	None	Over-Sensing, Inappropriate/Inadequate Shock/Stimulation, Inappropriate or Unexpected Reset
2019-02-15	Malfunction	None	Premature Discharge of Battery, Battery Problem
2019-02-13	Injury	None	Battery Problem
2019-02-11	Injury	None	Battery Problem
2019-02-10	Malfunction	None	Over-Sensing
2019-02-08	Injury	None	Battery Problem
2019-02-06	Injury	None	Battery Problem
2019-02-01	Injury	None	Battery Problem
2019-01-31	Injury	None	Premature Discharge of Battery
2019-01-30	Injury	None	Battery Problem
2019-01-27	Injury	None	Battery Problem
2019-01-22	Injury	None	Premature Discharge of Battery, Battery Problem
2019-01-22	Injury	None	Battery Problem
2019-01-21	Injury	None	Battery Problem
2019-01-15	Injury	None	Battery Problem
2019-01-13	Injury	None	Battery Problem
2019-01-10	Injury	None	Battery Problem
2019-01-09	Injury	None	Adverse Event Without Identified Device or Use Problem
2019-01-09	Injury	None	Battery Problem
2019-01-07	Malfunction	None	Failure to Charge
2019-01-07	Injury	None	Battery Problem
2019-01-07	Injury	None	Battery Problem
2019-01-07	Injury	None	Premature Discharge of Battery, Battery Problem
2019-01-07	Injury	None	Adverse Event Without Identified Device or Use Problem
2019-01-04	Injury	None	Battery Problem
2019-01-04	Malfunction	None	Adverse Event Without Identified Device or Use Problem
2019-01-03	Injury	None	Failure to Capture, Device Sensing Problem, Impedance Problem
2018-12-29	Injury	None	Battery Problem
2018-12-28	Malfunction	None	Adverse Event Without Identified Device or Use Problem
2018-12-27	Injury	None	Battery Problem
2018-12-27	Injury	None	Battery Problem
2018-12-26	Injury	None	Battery Problem
2018-12-26	Injury	None	Battery Problem
2018-12-26	Malfunction	None	Adverse Event Without Identified Device or Use Problem
2018-12-23	Injury	None	Failure to Charge, Battery Problem
2018-12-21	Injury	None	Adverse Event Without Identified Device or Use Problem
2018-12-18	Injury	None	Battery Problem
2018-12-14	Injury	None	Battery Problem
2018-12-14	Malfunction	None	Battery Problem
2018-12-13	Injury	None	Battery Problem
2018-12-13	Injury	None	Battery Problem
2018-12-11	Injury	None	Battery Problem
2018-12-10	Injury	None	Battery Problem
2018-12-08	Injury	None	Signal Artifact/Noise, Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2018-12-07	Injury	None	Battery Problem
2018-12-07	Injury	None	Battery Problem
2018-12-07	Injury	None	Battery Problem
2018-12-05	Injury	None	Battery Problem
2018-12-04	Injury	None	Failure to Interrogate
2018-12-04	Injury	None	Battery Problem
2018-11-30	Injury	None	Battery Problem
2018-11-29	Injury	None	Battery Problem
2018-11-27	Injury	None	Battery Problem
2018-11-27	Injury	None	Battery Problem
2018-11-25	Injury	None	Battery Problem
2018-11-20	Injury	None	Battery Problem
2018-11-18	Injury	No Clinical Signs, Symptoms or Conditions	Premature Discharge of Battery, Battery Problem
2018-11-18	Injury	None	Battery Problem
2018-11-09	Injury	None	Battery Problem
2018-11-08	Injury	None	Battery Problem
2018-11-07	Injury	None	Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2018-11-06	Injury	None	Battery Problem
2018-11-06	Injury	None	Adverse Event Without Identified Device or Use Problem
2018-11-02	Injury	None	Battery Problem
2018-11-02	Injury	None	Battery Problem
2018-10-31	Malfunction	None	Failure to Interrogate
2018-10-29	Injury	None	Premature Discharge of Battery, Battery Problem
2018-10-28	Injury	None	Adverse Event Without Identified Device or Use Problem
2018-10-28	Injury	None	Battery Problem
2018-10-24	Injury	None	Premature Elective Replacement Indicator, Battery Problem
2018-10-23	Injury	None	Battery Problem
2018-10-19	Injury	None	High impedance
2018-10-18	Injury	None	Battery Problem
2018-10-15	Injury	None	Adverse Event Without Identified Device or Use Problem
2018-10-15	Injury	None	Battery Problem
2018-10-09	Injury	None	Adverse Event Without Identified Device or Use Problem
2018-10-09	Injury	None	Signal Artifact/Noise, Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2018-10-08	Injury	None	Battery Problem
2018-10-08	Injury	None	Battery Problem
2018-10-07	Injury	None	Battery Problem
2018-10-04	Injury	None	Adverse Event Without Identified Device or Use Problem
2018-10-03	Injury	None	Battery Problem
2018-09-28	Injury	None	Battery Problem
2018-09-27	Malfunction	None	Battery Problem
2018-09-26	Injury	None	Failure to Interrogate, Wireless Communication Problem
2018-09-25	Malfunction	None	Battery Problem
2018-09-22	Injury	None	Battery Problem
2018-09-20	Injury	None	Battery Problem
2018-09-20	Malfunction	None	Battery Problem
2018-09-19	Injury	None	Battery Problem
2018-09-14	Injury	None	Battery Problem
2018-09-12	Injury	None	Premature Discharge of Battery, Battery Problem
2018-09-11	Injury	None	Battery Problem
2018-09-11	Injury	None	Battery Problem
2018-09-11	Injury	None	Battery Problem
2018-09-10	Injury	None	Premature Discharge of Battery
2018-09-06	Injury	None	Signal Artifact/Noise, Inappropriate/Inadequate Shock/Stimulation
2018-09-05	Injury	None	Adverse Event Without Identified Device or Use Problem
2018-09-05	Injury	None	Battery Problem
2018-09-05	Injury	None	Adverse Event Without Identified Device or Use Problem
2018-09-04	Injury	None	Failure to Deliver Shock/Stimulation, Inappropriate/Inadequate Shock/Stimulation
2018-09-02	Death	None	Adverse Event Without Identified Device or Use Problem
2018-08-29	Injury	None	Battery Problem
2018-08-28	Injury	None	Failure to Interrogate
2018-08-28	Injury	None	Battery Problem
2018-08-24	Injury	None	Battery Problem
2018-08-24	Injury	None	Battery Problem
2018-08-24	Injury	None	Battery Problem
2018-08-22	Malfunction	None	Battery Problem
2018-08-21	Injury	None	Battery Problem
2018-08-21	Malfunction	None	Battery Problem
2018-08-20	Injury	None	Battery Problem
2018-08-17	Injury	None	Battery Problem
2018-08-15	Injury	None	Adverse Event Without Identified Device or Use Problem
2018-08-13	Injury	None	Battery Problem, Adverse Event Without Identified Device or Use Problem
2018-08-10	Injury	None	Signal Artifact/Noise, Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2018-08-07	Injury	None	Adverse Event Without Identified Device or Use Problem
2018-08-01	Injury	None	Battery Problem
2018-07-28	Injury	None	Inappropriate/Inadequate Shock/Stimulation
2018-07-25	Injury	None	Adverse Event Without Identified Device or Use Problem
2018-07-20	Injury	None	Failure to Charge, Delayed Charge Time
2018-07-19	Injury	None	Battery Problem
2018-07-15	Injury	None	Premature Discharge of Battery, Failure to Interrogate
2018-07-14	Injury	None	Nonstandard Device, Low impedance, Battery Problem
2018-07-12	Injury	None	Battery Problem
2018-07-11	Injury	None	Premature Discharge of Battery, Failure to Interrogate
2018-07-10	Malfunction	Insufficient Information	Nonstandard Device
2018-07-08	Injury	None	Premature Discharge of Battery
2018-07-04	Injury	None	Battery Problem
2018-06-29	Injury	None	Battery Problem
2018-06-23	Injury	None	Adverse Event Without Identified Device or Use Problem
2018-06-21	Injury	None	Battery Problem
2018-06-20	Injury	None	Battery Problem
2018-06-19	Injury	None	Battery Problem
2018-06-18	Injury	None	Battery Problem
2018-06-12	Injury	None	Battery Problem
2018-06-12	Injury	None	Battery Problem
2018-06-09	Injury	None	Battery Problem
2018-06-06	Injury	None	Battery Problem
2018-06-02	Injury	None	Battery Problem
2018-05-26	Injury	None	Battery Problem
2018-05-23	Injury	None	Premature Discharge of Battery, Wireless Communication Problem
2018-05-23	Injury	None	Battery Problem
2018-05-22	Malfunction	None	Battery Problem
2018-05-22	Injury	None	Battery Problem
2018-05-19	Injury	None	Battery Problem
2018-05-18	Injury	None	Battery Problem
2018-05-17	Malfunction	None	Failure to Interrogate
2018-05-16	Injury	None	Migration or Expulsion of Device
2018-05-15	Injury	None	Battery Problem
2018-05-15	Injury	None	Failure to Interrogate, Battery Problem
2018-05-11	Malfunction	None	Adverse Event Without Identified Device or Use Problem
2018-05-10	Injury	None	Adverse Event Without Identified Device or Use Problem
2018-05-05	Injury	None	Battery Problem
2018-05-03	Injury	None	Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2018-05-01	Injury	None	Battery Problem
2018-04-27	Injury	None	Premature Discharge of Battery
2018-04-26	Injury	None	Battery Problem
2018-04-23	Malfunction	None	Failure to Interrogate, Material Deformation
2018-04-23	Injury	None	Battery Problem
2018-04-23	Injury	None	Premature Discharge of Battery
2018-04-22	Injury	None	Inappropriate/Inadequate Shock/Stimulation, Output Problem
2018-04-20	Injury	None	Battery Problem
2018-04-17	Injury	None	Battery Problem
2018-04-11	Injury	None	Failure to Interrogate
2018-04-11	Injury	None	Battery Problem
2018-04-10	Injury	None	Battery Problem
2018-04-04	Injury	None	Battery Problem
2018-04-04	Injury	None	Battery Problem
2018-04-02	Injury	None	Battery Problem
2018-03-29	Injury	None	Adverse Event Without Identified Device or Use Problem
2018-03-28	Injury	None	Battery Problem
2018-03-28	Injury	None	Adverse Event Without Identified Device or Use Problem
2018-03-28	Injury	None	Failure to Interrogate
2018-03-25	Injury	None	Battery Problem
2018-03-23	Injury	None	Battery Problem
2018-03-21	Injury	None	Adverse Event Without Identified Device or Use Problem
2018-03-20	Injury	None	Battery Problem
2018-03-20	Injury	None	Battery Problem
2018-03-17	Injury	None	Adverse Event Without Identified Device or Use Problem
2018-03-13	Injury	None	Failure to Deliver Shock/Stimulation, Failure to Convert Rhythm
2018-03-12	Injury	None	Battery Problem
2018-03-08	Injury	None	Battery Problem
2018-03-08	Malfunction	None	Over-Sensing
2018-03-07	Injury	None	Premature Discharge of Battery, Battery Problem
2018-03-04	Injury	None	Battery Problem
2018-03-02	Injury	None	Inappropriate/Inadequate Shock/Stimulation
2018-03-01	Injury	None	Premature Discharge of Battery, Inappropriate or Unexpected Reset
2018-02-27	Injury	None	Battery Problem
2018-02-25	Injury	None	Battery Problem
2018-02-21	Injury	None	Battery Problem
2018-02-20	Injury	None	Battery Problem
2018-02-20	Injury	None	Device Operates Differently Than Expected, Adverse Event Without Identified Device or Use Problem
2018-02-17	Malfunction	None	Battery Problem
2018-02-17	Injury	None	Battery Problem
2018-02-12	Injury	None	Adverse Event Without Identified Device or Use Problem
2018-02-12	Injury	None	Battery Problem
2018-02-08	Injury	None	Premature Discharge of Battery
2018-02-07	Injury	None	Adverse Event Without Identified Device or Use Problem
2018-02-07	Injury	None	Battery Problem
2018-02-06	Injury	None	Adverse Event Without Identified Device or Use Problem
2018-02-05	Injury	None	Failure to Interrogate, Battery Problem
2018-02-02	Injury	None	Delayed Charge Time, Battery Problem
2018-02-01	Injury	None	Battery Problem
2018-01-31	Injury	None	Battery Problem
2018-01-28	Injury	None	Battery Problem
2018-01-25	Injury	None	Premature Discharge of Battery, Battery Problem
2018-01-18	Injury	None	Battery Problem
2018-01-17	Injury	None	Battery Problem
2018-01-16	Injury	None	Battery Problem
2018-01-16	Malfunction	None	Battery Problem
2018-01-14	Malfunction	None	Battery Problem
2018-01-11	Injury	None	Adverse Event Without Identified Device or Use Problem
2018-01-11	Injury	None	Premature Discharge of Battery, Difficult to Interrogate, Output Problem
2018-01-09	Injury	None	Premature Discharge of Battery, Failure to Interrogate
2018-01-08	Injury	None	Adverse Event Without Identified Device or Use Problem
2018-01-08	Injury	None	Premature Discharge of Battery, Failure to Interrogate
2018-01-05	Injury	None	Battery Problem
2018-01-03	Injury	None	Premature Discharge of Battery
2018-01-02	Injury	None	Premature Discharge of Battery
2018-01-01	Malfunction	None	Battery Problem
2018-01-01	Injury	None	Battery Problem
2017-12-30	Malfunction	None	Inappropriate or Unexpected Reset
2017-12-29	Injury	None	Signal Artifact/Noise, Failure to Capture, Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2017-12-28	Injury	None	Battery Problem
2017-12-28	Malfunction	None	Battery Problem
2017-12-28	Injury	None	Battery Problem
2017-12-27	Injury	None	Premature Discharge of Battery
2017-12-22	Malfunction	None	Battery Problem
2017-12-21	Injury	None	Battery Problem
2017-12-19	Injury	None	Battery Problem
2017-12-19	Injury	None	Premature Discharge of Battery, Battery Problem
2017-12-14	Injury	None	Battery Problem
2017-12-13	Injury	None	Battery Problem
2017-12-13	Injury	None	Battery Problem
2017-12-13	Injury	None	Premature Discharge of Battery, Battery Problem
2017-12-12	Injury	None	Battery Problem
2017-12-08	Injury	None	Battery Problem
2017-12-07	Injury	None	Premature Discharge of Battery, Failure to Interrogate, Vibration
2017-12-03	Malfunction	None	Failure to Convert Rhythm
2017-12-01	Injury	None	Failure to Interrogate
2017-12-01	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-11-30	Injury	None	Battery Problem
2017-11-30	Injury	None	Battery Problem
2017-11-29	Malfunction	None	Over-Sensing
2017-11-29	Injury	None	Battery Problem
2017-11-29	Malfunction	None	Battery Problem
2017-11-27	Injury	None	Battery Problem
2017-11-27	Injury	None	Premature Discharge of Battery, Battery Problem
2017-11-25	Injury	None	Telemetry Discrepancy, Battery Problem
2017-11-24	Injury	None	Battery Problem
2017-11-24	Injury	None	Battery Problem
2017-11-21	Injury	None	Battery Problem
2017-11-20	Injury	None	Signal Artifact/Noise, Inappropriate/Inadequate Shock/Stimulation
2017-11-19	Injury	None	Battery Problem
2017-11-16	Injury	None	Battery Problem
2017-11-15	Death	None	Adverse Event Without Identified Device or Use Problem
2017-11-14	Injury	None	Battery Problem
2017-11-12	Injury	None	Battery Problem
2017-11-11	Injury	None	Battery Problem
2017-11-09	Injury	None	Premature Discharge of Battery, Failure to Interrogate
2017-11-07	Injury	None	Battery Problem
2017-11-07	Injury	None	Premature Discharge of Battery, Failure to Interrogate, Adverse Event Without Identified Device or Use Problem
2017-11-07	Injury	None	Battery Problem
2017-11-06	Injury	None	Battery Problem
2017-11-04	Injury	None	Premature Discharge of Battery, Battery Problem
2017-11-02	Injury	None	Battery Problem
2017-11-02	Injury	None	Battery Problem
2017-11-01	Injury	None	Battery Problem
2017-11-01	Injury	None	Battery Problem
2017-10-30	Injury	None	Battery Problem
2017-10-30	Injury	None	Battery Problem
2017-10-29	Injury	None	Battery Problem
2017-10-28	Injury	None	Premature Discharge of Battery, Battery Problem
2017-10-26	Injury	None	Battery Problem
2017-10-26	Injury	None	Battery Problem
2017-10-25	Injury	None	Battery Problem
2017-10-25	Injury	None	Battery Problem
2017-10-22	Injury	None	Battery Problem
2017-10-20	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-10-19	Injury	None	Premature Discharge of Battery, Battery Problem
2017-10-18	Injury	None	Battery Problem
2017-10-17	Injury	None	Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2017-10-15	Injury	None	Premature Discharge of Battery
2017-10-13	Injury	None	Battery Problem
2017-10-12	Injury	None	Battery Problem
2017-10-12	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-10-12	Injury	None	Battery Problem
2017-10-11	Malfunction	None	Battery Problem
2017-10-10	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-10-10	Injury	None	Battery Problem
2017-10-09	Injury	None	Battery Problem
2017-10-09	Injury	None	Battery Problem
2017-10-09	Injury	None	Battery Problem
2017-10-09	Injury	None	Battery Problem
2017-10-07	Injury	None	Battery Problem
2017-10-04	Injury	None	Battery Problem
2017-10-03	Injury	None	Battery Problem
2017-10-03	Malfunction	None	Battery Problem
2017-09-30	Injury	None	Defibrillation/Stimulation Problem, Output 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	Battery Problem
2017-09-27	Injury	None	Battery Problem
2017-09-27	Injury	None	Battery Problem
2017-09-26	Injury	None	Battery Problem
2017-09-26	Injury	None	Battery Problem
2017-09-25	Malfunction	None	Premature Discharge of Battery
2017-09-21	Injury	None	Battery Problem
2017-09-21	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-09-21	Injury	None	Inappropriate/Inadequate Shock/Stimulation, Device Operates Differently Than Expected
2017-09-21	Injury	None	Battery Problem
2017-09-20	Injury	None	Battery Problem
2017-09-18	Injury	None	Battery Problem
2017-09-18	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-09-18	Injury	None	Battery Problem
2017-09-17	Injury	None	Battery Problem
2017-09-17	Injury	None	Battery Problem
2017-09-16	Injury	None	Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2017-09-15	Injury	None	Premature Discharge of Battery, Failure to Interrogate, Telemetry Discrepancy
2017-09-14	Injury	None	Battery Problem
2017-09-14	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-09-14	Injury	None	Premature Discharge of Battery, Battery Problem
2017-09-14	Injury	None	Premature Discharge of Battery
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
2017-09-11	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
2017-09-11	Injury	None	Premature Discharge of Battery, Battery Problem
2017-09-10	Injury	None	Battery Problem
2017-09-10	Injury	None	Battery Problem
2017-09-10	Injury	None	Battery Problem
2017-09-10	Injury	None	Battery Problem
2017-09-10	Injury	None	Inappropriate/Inadequate Shock/Stimulation
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	Premature Discharge of Battery, 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
2017-09-06	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
2017-09-05	Injury	None	Battery Problem
2017-09-05	Injury	None	Battery Problem
2017-09-05	Injury	None	Battery Problem
2017-09-04	Injury	None	Battery Problem
2017-09-03	Injury	None	Battery Problem
2017-09-02	Injury	None	Battery Problem
2017-09-02	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-09-01	Injury	None	Battery Problem
2017-09-01	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-08-31	Injury	None	Battery Problem
2017-08-31	Injury	None	Failure to Interrogate
2017-08-30	Injury	None	Battery Problem
2017-08-30	Injury	None	Battery Problem
2017-08-30	Injury	None	Battery Problem
2017-08-29	Injury	None	Battery Problem
2017-08-28	Injury	None	Premature Discharge of Battery, Premature End-of-Life Indicator, Delayed Charge Time, Battery Problem
2017-08-28	Injury	None	Battery Problem
2017-08-28	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-08-28	Injury	None	Battery Problem
2017-08-28	Injury	None	Premature Discharge of Battery, Battery Problem
2017-08-26	Injury	None	Battery Problem
2017-08-26	Malfunction	None	Under-Sensing
2017-08-26	Injury	None	Battery Problem
2017-08-20	Injury	None	Inappropriate/Inadequate Shock/Stimulation, Device Operates Differently Than Expected
2017-08-16	Injury	None	Premature Discharge of Battery, Battery Problem
2017-08-14	Malfunction	None	Premature Discharge of Battery, Failure to Interrogate
2017-08-10	Malfunction	None	Inappropriate or Unexpected Reset
2017-08-08	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-08-08	Injury	None	Premature Discharge of Battery
2017-08-07	Death	None	Adverse Event Without Identified Device or Use Problem
2017-08-02	Injury	None	Inappropriate/Inadequate Shock/Stimulation, Inappropriate or Unexpected Reset
2017-07-31	Malfunction	None	Premature Discharge of Battery
2017-07-31	Injury	None	Premature Discharge of Battery
2017-07-28	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-07-24	Injury	None	Premature Discharge of Battery
2017-07-22	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-07-21	Injury	None	Premature Discharge of Battery
2017-07-14	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-07-05	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-07-03	Malfunction	None	Premature Discharge of Battery
2017-07-01	Injury	None	Premature Discharge of Battery, Premature Elective Replacement Indicator
2017-06-30	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-06-29	Injury	None	Inappropriate/Inadequate Shock/Stimulation, Output Problem
2017-06-29	Injury	None	Premature Discharge of Battery
2017-06-26	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-06-23	Injury	None	Premature Discharge of Battery
2017-06-20	Malfunction	Insufficient Information	Battery Problem
2017-06-20	Injury	None	Premature Discharge of Battery
2017-06-19	Malfunction	None	Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2017-06-19	Death	None	Adverse Event Without Identified Device or Use Problem
2017-06-14	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-06-14	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-06-12	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-06-07	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-06-06	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-06-06	Injury	None	Failure to Interrogate, Telemetry Discrepancy
2017-06-05	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-06-02	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-05-30	Injury	None	Premature Discharge of Battery, Failure to Interrogate
2017-05-29	Death	None	Adverse Event Without Identified Device or Use Problem
2017-05-27	Injury	None	Device Operates Differently Than Expected
2017-05-19	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-05-18	Malfunction	None	Connection Problem
2017-05-18	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-05-17	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-05-17	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-05-17	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-05-16	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-05-16	Injury	None	Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2017-05-15	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-05-12	Injury	None	Premature Discharge of Battery
2017-05-12	Injury	None	Inappropriate/Inadequate Shock/Stimulation, Delayed Charge Time
2017-05-10	Death	None	Defibrillation/Stimulation Problem
2017-05-10	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-05-08	Death	None	Output 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	Delayed Charge Time
2017-05-02	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-05-01	Injury	None	Failure to Interrogate
2017-04-30	Injury	None	Pacemaker Found in Back-Up Mode, Delayed Charge Time
2017-04-28	Injury	None	Premature Elective Replacement Indicator
2017-04-28	Injury	None	Wireless Communication Problem
2017-04-26	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-04-20	Injury	None	Premature Discharge of Battery
2017-04-20	Injury	None	Premature Discharge of Battery
2017-04-18	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-04-18	Injury	None	Premature Discharge of Battery, Premature Elective Replacement Indicator
2017-04-17	Injury	None	Premature Discharge of Battery
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
2017-04-13	Malfunction	None	Over-Sensing
2017-04-13	Malfunction	None	Defibrillation/Stimulation 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	Premature Discharge of Battery
2017-04-08	Malfunction	None	Over-Sensing
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
2017-04-06	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
2017-04-03	Injury	None	Premature Discharge of Battery, Difficult to Interrogate
2017-04-03	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-03-31	Injury	None	Inappropriate or Unexpected Reset
2017-03-30	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-03-29	Malfunction	None	Failure to Capture, Device Operates Differently Than Expected
2017-03-29	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-03-29	Injury	None	Over-Sensing
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
2017-03-23	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
2017-03-21	Injury	None	Premature Discharge of Battery, Failure to Interrogate
2017-03-20	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-03-19	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
2017-03-17	Injury	None	Premature End-of-Life Indicator
2017-03-17	Injury	None	Premature Discharge of Battery
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
2017-03-15	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
2017-03-13	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-03-13	Malfunction	None	Device Operates Differently Than Expected
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
2017-03-11	Injury	None	Premature End-of-Life Indicator, Battery Problem
2017-03-09	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-03-08	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-03-08	Malfunction	None	Failure to Interrogate
2017-03-08	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-03-08	Malfunction	None	Charging 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	Malfunction	None	High impedance
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	Malfunction	None	Inappropriate or Unexpected Reset
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	Failure to Interrogate, Output Problem
2017-03-06	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-03-05	Injury	None	Premature Discharge of Battery
2017-03-03	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-03-03	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-03-03	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
2017-03-02	Injury	None	Premature Discharge of Battery, Failure to Interrogate
2017-03-02	Malfunction	None	High impedance
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
2017-02-24	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
2017-02-22	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
2017-02-20	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	Adverse Event Without Identified Device or Use Problem
2017-02-17	Injury	None	Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
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
2017-02-16	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-02-15	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-02-14	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	Premature Discharge of Battery, Failure to Interrogate
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
2017-02-08	Injury	None	Premature Discharge of Battery, Failure to Interrogate, Nonstandard Device, No Pacing
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	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-02-06	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-02-03	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, Adverse Event Without Identified Device or Use Problem
2017-02-02	Injury	None	Premature Discharge of Battery, Premature Elective Replacement Indicator
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
2017-02-01	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-02-01	Malfunction	None	Vibration
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
2017-01-29	Injury	None	Premature Discharge of Battery, Failure to Interrogate, Premature Elective Replacement Indicator
2017-01-28	Injury	None	Premature Discharge of Battery, Delayed Charge Time
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
2017-01-27	Injury	None	Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
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
2017-01-23	Injury	None	Premature Discharge of Battery, Difficult to Interrogate
2017-01-23	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-01-22	Injury	None	Premature Discharge of Battery
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	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-01-20	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-01-19	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
2017-01-19	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-01-19	Injury	None	Premature Discharge of Battery, Nonstandard Device
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
2017-01-17	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
2017-01-16	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	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
2017-01-14	Malfunction	None	High impedance
2017-01-14	Injury	None	Inappropriate/Inadequate Shock/Stimulation, 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
2017-01-12	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	Premature Discharge of Battery, Premature Elective Replacement Indicator
2017-01-12	Injury	None	Adverse Event Without Identified Device or Use Problem
2017-01-12	Malfunction	Insufficient Information	Nonstandard Device
2017-01-12	Malfunction	Insufficient Information	Nonstandard Device
2017-01-12	Malfunction	Insufficient Information	Nonstandard Device
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
2017-01-09	Injury	None	Failure to Interrogate
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	Inappropriate/Inadequate Shock/Stimulation
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	Device Operates Differently Than Expected
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	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	Failure to Interrogate
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
2017-01-02	Malfunction	None	Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2017-01-02	Injury	None	Adverse Event Without Identified Device or Use Problem
2016-12-28	Malfunction	None	Device Operates Differently Than Expected
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
2016-12-22	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	Malfunction	None	Vibration
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
2016-12-21	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
2016-12-21	Injury	None	Adverse Event Without Identified Device or Use Problem
2016-12-21	Injury	None	Over-Sensing
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
2016-12-20	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
2016-12-16	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
2016-12-15	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	Malfunction	None	Failure to Interrogate, Nonstandard Device, Vibration
2016-12-13	Injury	None	Adverse Event Without Identified Device or Use Problem
2016-12-12	Injury	None	Premature Discharge of Battery
2016-12-12	Injury	None	Adverse Event Without Identified Device or Use Problem
2016-12-12	Malfunction	None	Vibration
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
2016-12-08	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	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	Malfunction	None	Over-Sensing
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	Premature Discharge of Battery
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
2016-12-02	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
2016-12-02	Injury	None	Adverse Event Without Identified Device or Use Problem
2016-12-02	Injury	No Clinical Signs, Symptoms or Conditions	Adverse Event Without Identified Device or Use Problem, No Apparent Adverse Event
2016-12-02	Malfunction	None	Vibration
2016-12-01	Injury	None	Premature Discharge of Battery, Failure to Capture
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	Malfunction	None	Difficult to Interrogate
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
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, Over-Sensing
2016-11-29	Injury	None	Adverse Event Without Identified Device or Use Problem
2016-11-29	Injury	None	Over-Sensing
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	Malfunction	None	Vibration
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
2016-11-26	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	Premature Elective Replacement Indicator
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	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	Adverse Event Without Identified Device or Use Problem
2016-11-21	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	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	Device Operates Differently Than Expected
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	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	Premature Elective Replacement Indicator
2016-11-16	Injury	None	Adverse Event Without Identified Device or Use Problem
2016-11-16	Malfunction	None	Defective Alarm
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	Premature Discharge of Battery
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	Premature Discharge of Battery, Failure to Interrogate
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
2016-11-11	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	Malfunction	None	Over-Sensing
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	Premature Discharge of Battery, Adverse Event Without Identified Device or Use Problem
2016-11-10	Injury	None	Premature Elective Replacement Indicator
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	Premature Discharge of Battery
2016-11-09	Injury	None	Premature Discharge of Battery
2016-11-09	Injury	None	Premature Discharge of Battery
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
2016-11-07	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
2016-11-04	Injury	None	Adverse Event Without Identified Device or Use Problem
2016-11-04	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
2016-11-02	Injury	None	Adverse Event Without Identified Device or Use Problem
2016-11-01	Injury	None	Adverse Event Without Identified Device or Use Problem
2016-10-31	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	Adverse Event Without Identified Device or Use Problem
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
2016-10-26	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
2016-10-26	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
2016-10-24	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	Premature Discharge of Battery
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	Injury	None	Adverse Event Without Identified Device or Use Problem
2016-10-20	Injury	None	Premature Discharge of Battery, Failure to Interrogate, Premature End-of-Life Indicator
2016-10-20	Injury	None	Adverse Event Without Identified Device or Use Problem
2016-10-20	Injury	None	Device Maintenance Issue, Over-Sensing, Defibrillation/Stimulation Problem, Output Problem
2016-10-20	Injury	None	Adverse Event Without Identified Device or Use Problem
2016-10-19	Injury	None	Premature Discharge of Battery
2016-10-18	Injury	None	Adverse Event Without Identified Device or Use Problem
2016-10-17	Injury	None	Adverse Event Without Identified Device or Use Problem
2016-10-17	Malfunction	None	Device Operates Differently Than Expected
2016-10-15	Injury	None	Adverse Event Without Identified Device or Use Problem
2016-10-14	Injury	None	Adverse Event Without Identified Device or Use Problem
2016-10-14	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
2016-10-11	Injury	None	Adverse Event Without Identified Device or Use Problem
2016-10-11	Injury	None	Adverse Event Without Identified Device or Use Problem
2016-10-10	Injury	None	Inappropriate/Inadequate Shock/Stimulation
2016-10-05	Death	None	Adverse Event Without Identified Device or Use Problem
2016-10-02	Injury	None	Premature Discharge of Battery, Premature Elective Replacement Indicator
2016-10-02	Injury	None	Inappropriate or Unexpected Reset, Output Problem
2016-10-01	Injury	None	Premature Elective Replacement Indicator
2016-09-30	Injury	None	Adverse Event Without Identified Device or Use Problem
2016-09-23	Injury	None	Adverse Event Without Identified Device or Use Problem
2016-09-22	Injury	None	Premature Discharge of Battery
2016-09-20	Injury	None	Premature Discharge of Battery, Failure to Interrogate
2016-09-18	Injury	None	Premature Discharge of Battery, Failure to Interrogate
2016-09-16	Malfunction	None	Inappropriate or Unexpected Reset
2016-09-15	Injury	None	Premature Discharge of Battery, Data Problem
2016-09-13	Injury	None	Premature Discharge of Battery, Failure to Interrogate
2016-09-12	Injury	None	Inappropriate/Inadequate Shock/Stimulation
2016-09-12	Injury	None	Premature Elective Replacement Indicator
2016-09-08	Injury	None	Premature Discharge of Battery, Failure to Interrogate, Pacing Problem
2016-09-06	Injury	None	Inappropriate/Inadequate Shock/Stimulation, Output Problem
2016-09-04	Injury	None	Inappropriate/Inadequate Shock/Stimulation
2016-09-03	Injury	None	Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2016-09-02	Malfunction	None	Inappropriate or Unexpected Reset
2016-09-02	Injury	None	Premature Discharge of Battery, Premature Elective Replacement Indicator
2016-08-31	Injury	None	Premature Discharge of Battery, Failure to Interrogate, Communication or Transmission Problem
2016-08-26	Injury	None	Inappropriate/Inadequate Shock/Stimulation
2016-08-22	Injury	None	Premature Discharge of Battery
2016-08-10	Injury	None	Failure to Convert Rhythm, Inappropriate/Inadequate Shock/Stimulation, Device Operates Differently Than Expected
2016-08-09	Death	None	Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2016-08-08	Injury	None	Premature Discharge of Battery, Failure to Interrogate
2016-08-07	Injury	None	Inappropriate/Inadequate Shock/Stimulation
2016-08-04	Injury	None	Over-Sensing
2016-08-04	Injury	None	Premature Discharge of Battery, Failure to Interrogate
2016-08-02	Injury	None	Premature Discharge of Battery, Failure to Interrogate, Low Battery
2016-08-02	Injury	None	Failure to Interrogate
2016-08-01	Injury	None	Premature Discharge of Battery, Over-Sensing
2016-07-27	Injury	None	Premature Discharge of Battery, Failure to Interrogate
2016-07-24	Death	None	Adverse Event Without Identified Device or Use Problem
2016-07-21	Injury	None	Premature Discharge of Battery, Failure to Interrogate
2016-07-20	Injury	None	Premature Discharge of Battery, Difficult to Interrogate
2016-07-18	Malfunction	None	Over-Sensing
2016-07-16	Malfunction	None	Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2016-07-13	Injury	None	Inappropriate/Inadequate Shock/Stimulation
2016-07-10	Injury	None	Inappropriate/Inadequate Shock/Stimulation, Under-Sensing
2016-07-09	Injury	None	Premature Discharge of Battery, Failure to Interrogate
2016-07-08	Injury	None	Premature Discharge of Battery
2016-07-05	Injury	None	Premature Elective Replacement Indicator
2016-06-29	Injury	None	Failure to Interrogate
2016-06-28	Injury	None	Premature Discharge of Battery, Failure to Interrogate
2016-06-22	Injury	None	Inappropriate/Inadequate Shock/Stimulation
2016-06-19	Death	None	Adverse Event Without Identified Device or Use Problem
2016-06-19	Injury	None	Failure to Analyze Signal, Defibrillation/Stimulation Problem
2016-06-17	Malfunction	None	Premature Discharge of Battery
2016-06-15	Injury	None	Premature Discharge of Battery, Difficult to Interrogate
2016-06-10	Injury	None	Premature Discharge of Battery, Failure to Interrogate
2016-06-08	Injury	None	Premature Discharge of Battery, Battery Problem
2016-06-07	Injury	None	Premature Discharge of Battery, Failure to Interrogate
2016-05-09	Injury	None	Premature Elective Replacement Indicator, Delayed Charge Time
2016-05-01	Malfunction	None	Premature Discharge of Battery
2016-04-15	Death	None	Adverse Event Without Identified Device or Use Problem
2016-04-10	Injury	None	Adverse Event Without Identified Device or Use Problem
2016-03-29	Injury	None	Premature Discharge of Battery
2015-12-11	Injury	None	Adverse Event Without Identified Device or Use Problem
2015-12-09	Death	None	Adverse Event Without Identified Device or Use Problem
2015-05-16	Death	None	Adverse Event Without Identified Device or Use Problem
2015-05-08	Malfunction	None	Over-Sensing
2015-04-07	Injury	None	Inappropriate/Inadequate Shock/Stimulation
2015-03-30	Injury	None	Delayed Charge Time
2015-03-25	Injury	None	Premature Discharge of Battery, Failure to Interrogate
2015-03-25	Injury	None	Premature Discharge of Battery, Failure to Interrogate
2015-03-17	Injury	None	Inappropriate/Inadequate Shock/Stimulation
2015-03-10	Injury	None	Inappropriate/Inadequate Shock/Stimulation
2015-03-06	Malfunction	None	Failure to Convert Rhythm
2015-03-05	Injury	None	Failure to Interrogate, Premature Elective Replacement Indicator
2015-02-25	Malfunction	None	Premature Elective Replacement Indicator
2015-02-22	Injury	None	High impedance, Decreased Sensitivity, High Capture Threshold
2015-02-18	Injury	None	Premature Discharge of Battery
2015-02-18	Injury	None	Premature Discharge of Battery
2015-02-06	Injury	None	Premature Discharge of Battery, Failure to Interrogate
2015-02-03	Injury	None	Failure to Interrogate
2015-01-07	Injury	None	Premature End-of-Life Indicator
2015-01-02	Injury	None	Failure to Interrogate
2015-01-02	Injury	None	Premature Discharge of Battery
2014-12-23	Injury	None	Failure to Interrogate
2014-12-01	Injury	None	Failure to Interrogate
2014-11-25	Injury	None	Premature Discharge of Battery
2014-11-13	Injury	None	Premature Elective Replacement Indicator
2014-11-04	Injury	None	Premature Elective Replacement Indicator
2014-11-04	Injury	None	Adverse Event Without Identified Device or Use Problem
2014-10-30	Injury	None	Premature Discharge of Battery, Failure to Interrogate
2014-10-28	Death	None	Adverse Event Without Identified Device or Use Problem
2014-10-28	Injury	None	Premature End-of-Life Indicator
2014-09-25	Injury	None	Premature Discharge of Battery
2014-09-19	Injury	None	Premature Discharge of Battery
2014-09-11	Injury	None	Premature Elective Replacement Indicator
2014-09-03	Injury	None	Premature Elective Replacement Indicator
2014-09-02	Injury	None	Premature Elective Replacement Indicator
2014-08-30	Injury	None	Premature Elective Replacement Indicator
2014-08-26	Injury	None	Premature Discharge of Battery
2014-08-15	Injury	None	Premature Elective Replacement Indicator
2014-08-07	Injury	None	Premature Discharge of Battery
2014-08-01	Injury	None	Premature Discharge of Battery
2014-07-31	Malfunction	None	Communication or Transmission Problem
2014-07-30	Malfunction	None	Device Operates Differently Than Expected
2014-07-28	Malfunction	None	Over-Sensing
2014-07-24	Malfunction	None	Device Operates Differently Than Expected
2014-07-14	Malfunction	None	Premature Discharge of Battery
2014-07-08	Injury	None	Premature Elective Replacement Indicator
2014-07-07	Injury	None	Failure to Interrogate
2014-07-07	Malfunction	None	False Alarm
2014-06-30	Malfunction	None	False Alarm
2014-06-26	Malfunction	None	False Alarm
2014-06-24	Malfunction	None	False Alarm
2014-06-23	Malfunction	None	False Alarm
2014-06-23	Malfunction	None	False Alarm
2014-06-23	Malfunction	None	False Alarm
2014-06-19	Malfunction	None	False Alarm
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	Injury	None	Premature Elective Replacement Indicator
2014-06-16	Malfunction	None	False Alarm
2014-06-13	Malfunction	None	False Alarm
2014-06-12	Malfunction	None	False Alarm
2014-06-11	Malfunction	None	False Alarm
2014-06-10	Malfunction	None	False Alarm
2014-05-31	Injury	None	Failure to Interrogate
2014-05-31	Injury	None	Failure to Interrogate
2014-05-29	Malfunction	None	False Alarm
2014-05-29	Injury	None	Premature Discharge of Battery
2014-05-29	Injury	None	Premature Discharge of Battery
2014-05-23	Death	None	Aborted Charge, Output Problem
2014-05-22	Malfunction	None	Difficult to Interrogate
2014-05-22	Malfunction	None	False Alarm
2014-05-20	Injury	None	Inappropriate/Inadequate Shock/Stimulation
2014-05-18	Malfunction	None	Device Sensing Problem
2014-05-16	Malfunction	None	False Alarm
2014-05-12	Malfunction	None	False Alarm
2014-05-12	Malfunction	None	False Alarm
2014-05-11	Injury	None	Inappropriate or Unexpected Reset
2014-05-05	Malfunction	None	False Alarm
2014-04-28	Malfunction	None	False Alarm
2014-04-28	Malfunction	None	False Alarm
2014-04-28	Injury	None	Failure to Fire
2014-04-24	Malfunction	None	False Alarm
2014-04-22	Injury	None	Premature Elective Replacement Indicator
2014-04-22	Injury	None	Premature Elective Replacement Indicator
2014-04-14	Malfunction	None	False Alarm
2014-04-14	Injury	None	Inappropriate/Inadequate Shock/Stimulation, Capturing Problem
2014-04-11	Malfunction	None	False Alarm
2014-04-10	Injury	None	Premature Elective Replacement Indicator
2014-04-10	Injury	None	Premature Elective Replacement Indicator
2014-04-08	Injury	None	Premature Discharge of Battery
2014-04-08	Injury	None	Premature Discharge of Battery
2014-04-01	Malfunction	None	False Alarm
2014-04-01	Malfunction	None	False Alarm
2014-03-27	Injury	None	Premature Discharge of Battery
2014-03-27	Malfunction	None	False Alarm
2014-03-27	Injury	None	Premature Discharge of Battery
2014-03-27	Death	None	Adverse Event Without Identified Device or Use Problem
2014-03-24	Malfunction	None	False Alarm
2014-03-22	Injury	None	Premature Elective Replacement Indicator
2014-03-18	Injury	None	Premature Discharge of Battery
2014-03-18	Injury	None	Premature Discharge of Battery
2014-03-13	Malfunction	None	False Alarm
2014-03-13	Malfunction	None	False Alarm
2014-03-10	Malfunction	None	False Alarm
2014-03-10	Malfunction	None	High impedance
2014-03-06	Injury	None	Failure to Interrogate
2014-03-06	Injury	None	Failure to Interrogate
2014-03-05	Malfunction	None	Premature Discharge of Battery
2014-03-05	Injury	None	Premature Discharge of Battery
2014-03-05	Malfunction	None	False Alarm
2014-03-04	Injury	None	Inappropriate/Inadequate Shock/Stimulation
2014-02-28	Malfunction	None	False Alarm
2014-02-26	Malfunction	None	False Alarm
2014-02-26	Malfunction	None	Over-Sensing
2014-02-25	Malfunction	None	False Alarm
2014-02-19	Injury	None	Premature Discharge of Battery
2014-02-17	Malfunction	None	False Alarm
2014-02-15	Injury	None	Inappropriate/Inadequate Shock/Stimulation
2014-02-15	Injury	None	Premature Elective Replacement Indicator
2014-02-15	Injury	None	Premature Elective Replacement Indicator
2014-02-12	Malfunction	None	False Alarm
2014-02-11	Malfunction	None	False Alarm
2014-02-09	Injury	None	Premature Discharge of Battery
2014-02-09	Injury	None	Premature Discharge of Battery
2014-02-06	Malfunction	None	False Alarm
2014-02-05	Malfunction	None	False Alarm
2014-01-28	Malfunction	None	Premature Discharge of Battery
2014-01-28	Malfunction	None	False Alarm
2014-01-27	Malfunction	None	False Alarm
2014-01-24	Injury	None	Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2014-01-22	Injury	None	Low impedance, Inappropriate or Unexpected Reset, Output Problem
2014-01-21	Malfunction	None	False Alarm
2014-01-17	Injury	None	Premature Discharge of Battery
2014-01-17	Injury	None	Premature Discharge of Battery
2014-01-17	Malfunction	None	False Alarm
2014-01-16	Injury	None	Inappropriate/Inadequate Shock/Stimulation
2014-01-16	Malfunction	None	False Alarm
2014-01-16	Malfunction	None	Decreased Sensitivity
2014-01-15	Malfunction	None	False Alarm
2014-01-14	Malfunction	None	False Alarm
2014-01-13	Malfunction	None	Failure to Interrogate
2014-01-13	Malfunction	None	Failure to Interrogate
2014-01-13	Malfunction	None	Failure to Interrogate
2014-01-13	Malfunction	None	High impedance
2014-01-13	Malfunction	None	Inappropriate or Unexpected Reset
2014-01-08	Malfunction	None	False Alarm
2014-01-08	Malfunction	None	Under-Sensing
2014-01-07	Injury	None	Device Operates Differently Than Expected
2013-12-27	Injury	None	Delayed Charge Time
2013-12-23	Malfunction	None	Electromagnetic Interference, Inappropriate or Unexpected Reset
2013-12-13	Injury	None	Premature Elective Replacement Indicator
2013-12-12	Injury	None	Inappropriate/Inadequate Shock/Stimulation
2013-12-04	Injury	None	Failure to Interrogate
2013-12-04	Injury	None	Failure to Interrogate
2013-11-30	Injury	None	Inappropriate/Inadequate Shock/Stimulation
2013-11-26	Malfunction	None	None
2013-11-25	Injury	None	None
2013-11-20	Malfunction	None	None
2013-11-14	Injury	None	None
2013-11-06	Malfunction	None	Over-Sensing
2013-11-04	Malfunction	None	None
2013-10-25	Injury	None	None
2013-10-21	Malfunction	None	Device Operates Differently Than Expected
2013-10-17	Injury	None	Failure to Interrogate
2013-10-13	Injury	None	Premature Elective Replacement Indicator
2013-10-13	Injury	None	Premature Elective Replacement Indicator
2013-10-11	Injury	None	None
2013-10-02	Injury	None	Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2013-10-02	Injury	None	None
2013-10-01	Malfunction	None	None
2013-09-30	Injury	None	None
2013-09-29	Injury	None	Premature Discharge of Battery
2013-09-29	Injury	None	None
2013-09-28	Injury	None	None
2013-09-25	Malfunction	None	None
2013-09-24	Death	None	None
2013-09-20	Malfunction	None	None
2013-09-19	Injury	None	None
2013-09-19	Injury	None	Premature Elective Replacement Indicator
2013-09-13	Malfunction	None	None
2013-09-05	Injury	None	Failure to Interrogate
2013-09-05	Injury	None	None
2013-09-04	Injury	None	None
2013-08-27	Injury	None	None
2013-08-21	Injury	None	None
2013-08-21	Injury	None	Premature Discharge of Battery
2013-08-15	Injury	None	None
2013-08-15	Injury	None	None
2013-08-15	Injury	None	None
2013-08-06	Injury	None	None
2013-07-26	Injury	None	None
2013-07-23	Malfunction	None	None
2013-07-22	Injury	None	None
2013-07-18	Injury	None	None
2013-07-17	Malfunction	None	None
2013-07-16	Injury	None	None
2013-07-15	Injury	None	None
2013-07-11	Injury	None	None
2013-07-11	Injury	None	Failure to Interrogate, Premature Elective Replacement Indicator
2013-07-06	Death	None	None
2013-07-01	Malfunction	None	None
2013-06-26	Malfunction	None	Delayed Charge Time
2013-06-21	Injury	None	None
2013-06-21	Injury	None	None
2013-06-16	Injury	None	None
2013-06-15	Injury	None	None
2013-06-15	Injury	None	Premature Elective Replacement Indicator
2013-06-10	Injury	None	Premature Discharge of Battery
2013-06-10	Injury	None	None
2013-06-09	Injury	None	None
2013-06-05	Malfunction	None	None
2013-05-31	Malfunction	None	None
2013-05-26	Injury	None	None
2013-05-23	Injury	None	Adverse Event Without Identified Device or Use Problem
2013-05-15	Injury	None	None
2013-05-12	Injury	None	None
2013-05-03	Malfunction	None	None
2013-05-02	Injury	None	None
2013-05-02	Injury	None	None
2013-04-25	Injury	None	None
2013-04-25	Injury	None	Premature Elective Replacement Indicator
2013-04-22	Malfunction	None	None
2013-04-11	Malfunction	None	None
2013-04-09	Malfunction	None	None
2013-04-08	Injury	None	Premature Elective Replacement Indicator
2013-04-08	Injury	None	None
2013-04-03	Injury	None	None
2013-04-01	Malfunction	None	None
2013-03-27	Injury	None	None
2013-03-26	Malfunction	None	None
2013-03-19	Injury	None	None
2013-03-17	Injury	None	None
2013-03-13	Malfunction	None	None
2013-03-11	Injury	None	None
2013-03-05	Malfunction	None	Device Operates Differently Than Expected
2013-02-28	Malfunction	None	None
2013-02-27	Injury	None	None
2013-02-26	Malfunction	None	None
2013-02-04	Injury	None	None
2013-02-02	Malfunction	None	None
2013-01-16	Malfunction	None	Under-Sensing
2013-01-04	Malfunction	None	None
2012-12-17	Injury	None	Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2012-12-11	Malfunction	None	None
2012-12-11	Injury	None	Premature Elective Replacement Indicator
2012-11-14	Injury	None	Inappropriate/Inadequate Shock/Stimulation
2012-11-12	Injury	None	Device Sensing Problem
2012-11-01	Malfunction	None	Inappropriate or Unexpected Reset
2012-10-24	Injury	None	None
2012-10-11	Malfunction	None	None
2012-10-11	Injury	None	Premature End-of-Life Indicator
2012-10-05	Malfunction	None	None
2012-10-03	Injury	None	Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2012-09-17	Malfunction	None	None
2012-09-12	Malfunction	None	Device Displays Incorrect Message
2012-08-27	Malfunction	None	None
2012-08-16	Malfunction	None	None
2012-08-15	Malfunction	None	None
2012-08-15	Injury	None	Inappropriate/Inadequate Shock/Stimulation
2012-07-31	Malfunction	None	None
2012-07-23	Malfunction	None	High Capture Threshold
2012-07-17	Injury	None	Inappropriate/Inadequate Shock/Stimulation
2012-07-10	Injury	None	None
2012-07-09	Injury	None	None
2012-06-26	Malfunction	None	None
2012-06-12	Injury	None	Inappropriate/Inadequate Shock/Stimulation
2012-05-23	Injury	None	Inappropriate/Inadequate Shock/Stimulation
2012-05-10	Injury	None	None
2012-05-04	Injury	None	Failure to Interrogate
2012-05-04	Injury	None	Over-Sensing, Failure to Sense, Inappropriate/Inadequate Shock/Stimulation
2012-05-03	Malfunction	None	None
2012-04-27	Injury	None	Inappropriate/Inadequate Shock/Stimulation
2012-04-24	Injury	None	None
2012-04-18	Injury	None	None
2012-04-13	Injury	None	None
2012-04-09	Injury	None	None
2012-04-04	Malfunction	None	Impedance Problem
2012-04-02	Injury	None	None
2012-03-30	Injury	None	None
2012-03-29	Injury	None	Inappropriate/Inadequate Shock/Stimulation
2012-03-28	Injury	None	None
2012-03-24	Injury	None	Inappropriate/Inadequate Shock/Stimulation
2012-03-22	Malfunction	None	Under-Sensing
2012-03-20	Injury	None	None
2012-03-15	Injury	None	None
2012-03-12	Injury	None	None
2012-03-10	Injury	None	None
2012-03-09	Injury	None	None
2012-03-06	Injury	None	None
2012-03-01	Malfunction	None	None
2012-02-16	Injury	None	None
2012-02-13	Injury	None	None
2012-01-20	Injury	None	None
2012-01-13	Injury	None	Over-Sensing, Inappropriate/Inadequate Shock/Stimulation
2012-01-13	Injury	None	None
2012-01-10	Injury	None	None
2012-01-09	Injury	None	None
2011-12-30	Injury	None	None
2011-12-09	Malfunction	None	Device Operates Differently Than Expected
2011-12-09	Malfunction	None	Delayed Charge Time
2011-12-07	Injury	None	None
2011-12-06	Injury	None	None
2011-11-28	Malfunction	None	Inappropriate or Unexpected Reset
2011-11-17	Injury	None	None
2011-11-14	Malfunction	None	None
2011-11-09	Injury	None	Inappropriate/Inadequate Shock/Stimulation
2011-11-09	Injury	None	Inappropriate/Inadequate Shock/Stimulation
2011-11-07	Injury	None	None
2011-11-04	Injury	None	None
2011-10-31	Injury	None	None
2011-10-28	Injury	None	None
2011-10-19	Injury	None	None
2011-10-19	Injury	None	Inappropriate/Inadequate Shock/Stimulation
2011-10-14	Injury	None	None
2011-10-13	Injury	None	Inappropriate/Inadequate Shock/Stimulation
2011-10-06	Injury	None	None
2011-10-06	Injury	None	None
2011-09-27	Injury	None	None
2011-09-26	Injury	None	None
2011-09-26	Malfunction	None	Difficult to Interrogate
2011-09-13	Injury	None	Inappropriate/Inadequate Shock/Stimulation
2011-09-09	Malfunction	None	Device Operates Differently Than Expected
2011-09-08	Injury	None	None
2011-09-07	Malfunction	None	Impedance Problem
2011-09-01	Injury	None	Inappropriate/Inadequate Shock/Stimulation
2011-09-01	Malfunction	None	Device Operates Differently Than Expected
2011-08-24	Injury	None	None
2011-08-22	Injury	None	Inappropriate/Inadequate Shock/Stimulation
2011-08-22	Injury	None	None
2011-08-16	Malfunction	None	Failure to Interrogate
2011-08-16	Injury	None	None
2011-08-07	Injury	None	None
2011-08-07	Injury	None	None
2011-08-03	Injury	None	None
2011-08-02	Injury	None	None
2011-07-28	Injury	None	None
2011-07-27	Injury	None	Inappropriate/Inadequate Shock/Stimulation
2011-07-19	Malfunction	None	None
2011-07-15	Malfunction	None	Failure to Interrogate
2011-07-14	Injury	None	None
2011-07-11	Malfunction	None	None
2011-07-01	Injury	None	None
2011-06-10	Injury	None	None
2011-06-07	Injury	None	None
2011-06-07	Malfunction	None	None
2011-06-01	Injury	None	None
2011-06-01	Injury	None	None
2011-05-31	Injury	None	None
2011-05-19	Injury	None	None
2011-05-16	Malfunction	None	None
2011-05-12	Injury	None	Inappropriate/Inadequate Shock/Stimulation, Inappropriate or Unexpected Reset
2011-05-12	Injury	None	None
2011-04-22	Injury	None	None
2011-04-06	Malfunction	None	None
2011-04-02	Death	None	None
2011-04-02	Malfunction	None	Device Operates Differently Than Expected
2011-04-01	Injury	None	None
2011-03-31	Injury	None	None
2011-03-25	Injury	None	None
2011-03-24	Injury	None	None
2011-03-24	Malfunction	None	High impedance
2011-03-24	Injury	None	None
2011-03-23	Injury	None	None
2011-03-21	Injury	None	None
2011-03-16	Injury	None	None
2011-03-09	Injury	None	None
2011-02-09	Malfunction	None	Inappropriate or Unexpected Reset
2011-02-08	Injury	None	None
2011-01-03	Injury	None	None
2010-12-20	Death	None	Adverse Event Without Identified Device or Use Problem
2010-10-20	Injury	None	None
2010-09-16	Injury	None	None
2010-09-03	Injury	None	None