IMPLANTABLE CHF GENERATOR
This device is manufactured by BOSTON SCIENTIFIC CORPORATION, GUIDANT CRM CLONMEL IRELAND, UNKNOWN.
The following problems were reported about this device:
| Date | Event Type | Patient Problem | Device Problem |
|---|---|---|---|
| 2024-06-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-06-26 | Injury | Arrhythmia | None |
| 2024-06-24 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance, Pacing Problem, Data Problem |
| 2024-06-03 | Injury | Shock from Patient Lead(s) | Pacing Problem, Inappropriate/Inadequate Shock/Stimulation |
| 2024-05-17 | Malfunction | Failure of Implant | None |
| 2024-05-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pacing Problem, Under-Sensing |
| 2024-05-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2024-05-02 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pacing Problem, Impedance Problem |
| 2024-04-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Interrogation Problem |
| 2024-04-28 | Injury | Ventricular Fibrillation, Shock from Patient Lead(s) | Pacing Problem, Failure to Convert Rhythm, Inappropriate/Inadequate Shock/Stimulation, Inaccurate Synchronization |
| 2024-04-17 | Death | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2024-04-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Signal Artifact/Noise, Over-Sensing |
| 2024-04-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance |
| 2024-03-29 | Injury | Asystole | None |
| 2024-03-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Over-Sensing, Pacing Problem |
| 2024-03-01 | Injury | Unspecified Infection, Sepsis | Adverse Event Without Identified Device or Use Problem |
| 2024-02-23 | Malfunction | No Clinical Signs, Symptoms or Conditions | Signal Artifact/Noise, Over-Sensing |
| 2024-02-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Off-Label Use, Low impedance |
| 2024-02-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance |
| 2024-02-20 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2024-02-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture |
| 2024-02-08 | Injury | No Clinical Signs, Symptoms or Conditions | Defective Device |
| 2024-01-31 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2024-01-11 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2024-01-04 | Injury | Ventricular Fibrillation, Asystole | Signal Artifact/Noise, Over-Sensing, Pacing Problem, Inaccurate Synchronization |
| 2023-12-13 | Injury | Syncope/Fainting | Defective Device |
| 2023-12-08 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2023-11-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2023-10-24 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-10-21 | Malfunction | Dizziness | Failure to Capture, Over-Sensing, Pacing Problem |
| 2023-10-20 | Injury | Unspecified Infection, Sepsis | Adverse Event Without Identified Device or Use Problem |
| 2023-10-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2023-10-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Signal Artifact/Noise, High impedance, Noise, Audible |
| 2023-10-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2023-10-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance, Off-Label Use |
| 2023-09-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance |
| 2023-09-20 | Injury | Bacterial Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-09-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance |
| 2023-09-02 | Malfunction | No Clinical Signs, Symptoms or Conditions | Signal Artifact/Noise, Over-Sensing |
| 2023-09-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance, High Capture Threshold |
| 2023-08-25 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-08-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Over-Sensing, Pacing Problem |
| 2023-08-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | Under-Sensing |
| 2023-08-16 | Injury | Bacterial Infection, Sepsis | Adverse Event Without Identified Device or Use Problem |
| 2023-08-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | Defective Device |
| 2023-08-11 | Injury | Abscess, Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-08-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture, Low impedance |
| 2023-07-28 | Malfunction | No Clinical Signs, Symptoms or Conditions | Under-Sensing |
| 2023-07-11 | Death | Arrhythmia, Erosion, Low Blood Pressure/ Hypotension, Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-07-11 | Injury | No Clinical Signs, Symptoms or Conditions | Telemetry Discrepancy |
| 2023-06-21 | Injury | Arrhythmia | Pacing Problem, Inappropriate/Inadequate Shock/Stimulation, Failure to Read Input Signal |
| 2023-06-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance, High Capture Threshold |
| 2023-06-05 | Injury | Ventricular Fibrillation, Syncope/Fainting | Failure to Read Input Signal, Inaccurate Synchronization, Under-Sensing |
| 2023-05-29 | Injury | Electric Shock | Inappropriate/Inadequate Shock/Stimulation, Inaccurate Synchronization |
| 2023-05-10 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-04-19 | Injury | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings, Inappropriate or Unexpected Reset |
| 2023-02-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance |
| 2023-01-17 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-01-14 | Injury | Ventricular Fibrillation | Failure to Read Input Signal, Inaccurate Synchronization, Under-Sensing, Device Sensing Problem |
| 2023-01-11 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2022-12-28 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance |
| 2022-12-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pacing Problem, Failure to Read Input Signal |
| 2022-12-01 | Injury | Syncope/Fainting | Defective Device |
| 2022-11-28 | Injury | None | Premature Discharge of Battery, Telemetry Discrepancy, Battery Problem |
| 2022-11-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | Data Problem |
| 2022-09-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-09-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture, Pacing Problem |
| 2022-09-05 | Injury | None | Premature Discharge of Battery, Noise, Audible |
| 2022-09-02 | Injury | None | Premature Discharge of Battery |
| 2022-08-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-08-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-07-13 | Injury | None | Premature Discharge of Battery |
| 2022-07-12 | Malfunction | None | Failure to Capture, Over-Sensing, Pacing Problem, Inappropriate/Inadequate Shock/Stimulation |
| 2022-03-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-02-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-02-16 | Injury | None | Signal Artifact/Noise, High impedance, Over-Sensing |
| 2022-02-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-02-10 | Malfunction | None | Pacing Problem, Inappropriate/Inadequate Shock/Stimulation |
| 2022-02-09 | Injury | None | Premature Discharge of Battery |
| 2022-01-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-01-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2021-12-22 | Malfunction | None | Over-Sensing, Impedance Problem |
| 2021-12-15 | Malfunction | Device Overstimulation of Tissue, Asystole | Signal Artifact/Noise, Over-Sensing, Pacing Problem |
| 2021-11-23 | Injury | No Clinical Signs, Symptoms or Conditions | Signal Artifact/Noise, Over-Sensing, Low impedance, Impedance Problem, Noise, Audible |
| 2021-10-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Over-Sensing, Failure to Convert Rhythm, Unexpected Therapeutic Results, Under-Sensing |
| 2021-06-27 | Malfunction | None | Over-Sensing |
| 2021-01-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Over-Sensing |
| 2020-04-26 | Malfunction | None | High impedance |
| 2020-01-21 | Malfunction | None | High impedance, Pacing Problem |
| 2019-09-05 | Injury | None | Premature Discharge of Battery, Device Displays Incorrect Message |
| 2019-08-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-07-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-07-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-07-28 | Malfunction | None | Pacing Problem, Inappropriate/Inadequate Shock/Stimulation |
| 2019-07-26 | Injury | None | High impedance, Over-Sensing |
| 2019-07-10 | Malfunction | None | High impedance |
| 2019-07-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-07-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-07-07 | Malfunction | None | Pacing Problem, Inappropriate/Inadequate Shock/Stimulation, Unintended Electrical Shock |
| 2019-07-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-26 | Injury | None | Patient-Device Incompatibility |
| 2019-06-24 | Malfunction | None | Defective Device |
| 2019-06-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-07 | Injury | None | Device Displays Incorrect Message |
| 2019-06-05 | Malfunction | None | Pacing Problem, Unexpected Therapeutic Results, Low impedance |
| 2019-06-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-01 | Injury | None | Over-Sensing, Pacing Problem, Unexpected Therapeutic Results, Device Sensing Problem, High Capture Threshold |
| 2019-05-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-14 | Injury | None | High impedance, Pacing Problem, Inappropriate/Inadequate Shock/Stimulation, Device Displays Incorrect Message, Device Sensing Problem, High Capture Threshold |
| 2019-05-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-08 | Malfunction | None | High impedance, Over-Sensing |
| 2019-05-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-29 | Malfunction | None | High impedance, Connection Problem |
| 2019-04-18 | Injury | None | Patient-Device Incompatibility |
| 2019-04-18 | Malfunction | None | High impedance |
| 2019-04-16 | Malfunction | None | Over-Sensing, Impedance Problem |
| 2019-04-16 | Malfunction | None | High impedance, Over-Sensing |
| 2019-04-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-11 | Malfunction | None | Over-Sensing, Pacing Problem, Inappropriate/Inadequate Shock/Stimulation, Device Sensing Problem |
| 2019-04-09 | Injury | None | Over-Sensing, Pacing Problem, Device Sensing Problem |
| 2019-04-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-22 | Injury | None | Under-Sensing |
| 2019-03-22 | Malfunction | None | High impedance, Over-Sensing, Defective Device |
| 2019-03-21 | Malfunction | None | Over-Sensing |
| 2019-03-21 | Malfunction | None | Unexpected Therapeutic Results |
| 2019-03-20 | Injury | None | Premature Discharge of Battery |
| 2019-03-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-08 | Malfunction | None | High impedance |
| 2019-03-07 | Malfunction | None | High impedance, Over-Sensing, Device Sensing Problem |
| 2019-03-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-06 | Injury | None | Premature Discharge of Battery, Noise, Audible |
| 2019-03-04 | Malfunction | None | High impedance |
| 2019-03-01 | Malfunction | None | Pacing Problem, Inappropriate/Inadequate Shock/Stimulation |
| 2019-02-28 | Malfunction | None | High impedance |
| 2019-02-21 | Malfunction | None | High impedance |
| 2019-02-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-18 | Malfunction | None | Signal Artifact/Noise, High impedance, Over-Sensing, Low impedance, Device Sensing Problem |
| 2019-02-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-29 | Injury | None | Unexpected Therapeutic Results |
| 2019-01-28 | Malfunction | None | Over-Sensing |
| 2019-01-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-17 | Malfunction | None | Failure to Capture, Defective Device |
| 2019-01-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-14 | Malfunction | None | Over-Sensing, Pacing Problem, Device Sensing Problem |
| 2019-01-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-05 | Malfunction | None | High impedance, Noise, Audible |
| 2019-01-03 | Injury | None | Defective Device |
| 2019-01-01 | Malfunction | None | High impedance |
| 2019-01-01 | Malfunction | None | High impedance, Over-Sensing |
| 2018-12-25 | Malfunction | None | Material Integrity Problem |
| 2018-12-22 | Malfunction | None | Failure to Convert Rhythm, Unexpected Therapeutic Results |
| 2018-12-19 | Malfunction | None | No Audible Alarm |
| 2018-12-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-12-16 | Injury | None | High impedance, Over-Sensing, Pacing Problem, Connection Problem, Device Sensing Problem |
| 2018-12-14 | Malfunction | Calcium Deposits/Calcification | High impedance |
| 2018-12-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-29 | Injury | None | Device Displays Incorrect Message |
| 2018-11-29 | Injury | None | Pacing Problem |
| 2018-11-26 | Injury | None | Inappropriate/Inadequate Shock/Stimulation |
| 2018-11-23 | Malfunction | None | Failure to Capture, High impedance, Device Displays Incorrect Message, High Capture Threshold |
| 2018-11-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-08 | Malfunction | None | High impedance |
| 2018-11-02 | Injury | None | Off-Label Use, Adverse Event Without Identified Device or Use Problem |
| 2018-11-01 | Injury | None | Defective Device |
| 2018-10-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-31 | Malfunction | None | Data Problem |
| 2018-10-30 | Injury | None | Device Displays Incorrect Message |
| 2018-10-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-11 | Injury | None | Over-Sensing, Pacing Problem |
| 2018-10-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-09 | Injury | None | Failure to Capture, High impedance, Over-Sensing, Device Sensing Problem, High Capture Threshold |
| 2018-10-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-26 | Malfunction | None | Under-Sensing |
| 2018-09-25 | Malfunction | None | Failure to Capture |
| 2018-09-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-14 | Malfunction | None | Signal Artifact/Noise, Failure to Capture, High impedance, Device Sensing Problem, High Capture Threshold |
| 2018-09-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-14 | Malfunction | None | Defective Device, Device Sensing Problem |
| 2018-09-13 | Malfunction | None | High impedance |
| 2018-09-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-10 | Malfunction | None | High impedance, Noise, Audible |
| 2018-09-09 | Malfunction | None | High impedance |
| 2018-09-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-07 | Malfunction | None | Device Displays Incorrect Message |
| 2018-09-01 | Malfunction | None | High impedance |
| 2018-09-01 | Malfunction | None | Low impedance, Device Sensing Problem |
| 2018-08-31 | Injury | None | Pacing Problem |
| 2018-08-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-29 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2018-08-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-27 | Malfunction | None | Pacing Problem, Failure to Convert Rhythm, Inappropriate/Inadequate Shock/Stimulation |
| 2018-08-27 | Malfunction | None | Failure to Capture, Over-Sensing, Ambient Noise Problem, Capturing Problem, Device Sensing Problem |
| 2018-08-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-22 | Injury | None | Device Sensing Problem |
| 2018-08-20 | Malfunction | None | High impedance |
| 2018-08-15 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem, Migration |
| 2018-08-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-10 | Injury | None | Pocket Stimulation, Device Displays Incorrect Message |
| 2018-08-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-09 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2018-08-09 | Injury | None | Defective Device |
| 2018-08-08 | Malfunction | None | Pacing Problem |
| 2018-08-08 | Injury | None | Failure to Capture, High impedance, Over-Sensing, Ambient Noise Problem, Device Sensing Problem |
| 2018-08-06 | Injury | None | Failure to Capture |
| 2018-08-05 | Malfunction | None | Over-Sensing, Ambient Noise Problem |
| 2018-08-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-02 | Malfunction | None | Pacing Problem |
| 2018-08-01 | Malfunction | None | High impedance |
| 2018-07-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-30 | Injury | None | Defective Device |
| 2018-07-26 | Malfunction | None | Low impedance, Device Sensing Problem |
| 2018-07-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-23 | Malfunction | None | Failure to Convert Rhythm, Inappropriate/Inadequate Shock/Stimulation |
| 2018-07-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-10 | Malfunction | None | High impedance |
| 2018-07-10 | Injury | Syncope/Fainting | Defective Device |
| 2018-07-09 | Injury | None | Defective Device |
| 2018-07-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-07 | Injury | None | Failure to Capture, Low impedance, Capturing Problem, Device Sensing Problem |
| 2018-07-03 | Malfunction | None | Over-Sensing, Ambient Noise Problem |
| 2018-07-02 | Injury | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2018-06-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-26 | Injury | None | High impedance, Use of Device Problem, Connection Problem |
| 2018-06-26 | Malfunction | None | Over-Sensing, Device Sensing Problem |
| 2018-06-21 | Malfunction | None | Over-Sensing, Pacing Problem, Material Integrity Problem |
| 2018-06-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-17 | Malfunction | None | Over-Sensing |
| 2018-06-12 | Malfunction | None | High impedance, Ambient Noise Problem |
| 2018-06-12 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2018-06-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-07 | Injury | None | Defective Device |
| 2018-06-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-30 | Injury | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2018-05-21 | Malfunction | None | Over-Sensing, Ambient Noise Problem, Impedance Problem |
| 2018-05-16 | Malfunction | None | High impedance |
| 2018-05-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-14 | Malfunction | None | High impedance |
| 2018-05-12 | Malfunction | None | Device Alarm System, High impedance |
| 2018-05-11 | Injury | None | Migration or Expulsion of Device, Adverse Event Without Identified Device or Use Problem |
| 2018-05-11 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-05-10 | Injury | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2018-05-06 | Malfunction | None | High impedance |
| 2018-05-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-02 | Injury | None | Over-Sensing, Capturing Problem |
| 2018-05-01 | Malfunction | None | Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2018-04-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-11 | Injury | None | Device Alarm System, High impedance, Over-Sensing, Ambient Noise Problem |
| 2018-04-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-10 | Injury | None | Pacing Problem |
| 2018-04-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-09 | Injury | None | No Audible Alarm, Premature Discharge of Battery, Communication or Transmission Problem |
| 2018-04-05 | Malfunction | None | Over-Sensing, Impedance Problem |
| 2018-04-04 | Malfunction | None | High impedance |
| 2018-04-04 | Malfunction | None | High impedance, Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2018-04-03 | Malfunction | None | Device Displays Incorrect Message |
| 2018-04-01 | Malfunction | None | Pocket Stimulation, Low impedance |
| 2018-04-01 | Injury | None | High impedance, Ambient Noise Problem, Connection Problem |
| 2018-03-30 | Malfunction | None | High impedance |
| 2018-03-30 | Malfunction | None | Over-Sensing |
| 2018-03-29 | Injury | None | Communication or Transmission Problem, Adverse Event Without Identified Device or Use Problem |
| 2018-03-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-28 | Malfunction | None | Over-Sensing |
| 2018-03-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-22 | Malfunction | None | High impedance, Over-Sensing, Defective Device, Ambient Noise Problem |
| 2018-03-20 | Injury | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2018-03-19 | Malfunction | None | High impedance |
| 2018-03-19 | Malfunction | None | High impedance |
| 2018-03-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-15 | Malfunction | None | High impedance, Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2018-03-12 | Injury | None | High impedance |
| 2018-03-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-05 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-05 | Injury | None | Defective Device |
| 2018-03-05 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-03-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-01 | Malfunction | None | High impedance |
| 2018-02-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-02-27 | Malfunction | None | Ambient Noise Problem |
| 2018-02-26 | Injury | None | Pacing Problem, Defective Device |
| 2018-02-25 | Malfunction | None | Over-Sensing, Ambient Noise Problem |
| 2018-02-23 | Injury | None | Failure to Sense |
| 2018-02-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-02-23 | Death | None | Defective Device |
| 2018-02-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-02-21 | Injury | None | Device Operates Differently Than Expected |
| 2018-02-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-02-21 | Injury | None | Premature Discharge of Battery, High impedance, Over-Sensing, Incorrect, Inadequate or Imprecise Result or Readings, Low impedance, Delayed Charge Time, Battery Problem |
| 2018-02-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-02-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-02-12 | Malfunction | None | Device Alarm System, High impedance |
| 2018-02-11 | Injury | None | Defective Device |
| 2018-02-09 | Injury | None | Failure to Capture, Capturing Problem |
| 2018-02-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-02-05 | Malfunction | None | Electrical /Electronic Property Problem, Over-Sensing, Ambient Noise Problem, Impedance Problem |
| 2018-02-01 | Malfunction | None | High impedance |
| 2018-02-01 | Malfunction | None | High impedance |
| 2018-02-01 | Malfunction | None | High impedance |
| 2018-02-01 | Malfunction | None | Over-Sensing, Ambient Noise Problem |
| 2018-01-26 | Malfunction | None | Over-Sensing, Pacing Problem, Ambient Noise Problem, Device Sensing Problem |
| 2018-01-25 | Injury | None | Device Operates Differently Than Expected |
| 2018-01-25 | Malfunction | None | Over-Sensing, Pacing Problem, Fitting Problem, Ambient Noise Problem |
| 2018-01-21 | Malfunction | None | Over-Sensing, Ambient Noise Problem |
| 2018-01-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-17 | Malfunction | None | Over-Sensing, Ambient Noise Problem |
| 2018-01-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-11 | Malfunction | None | High impedance, Over-Sensing, Device Sensing Problem |
| 2018-01-10 | Malfunction | None | High impedance, Over-Sensing, Pacing Problem, Data Problem |
| 2018-01-10 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2018-01-10 | Injury | None | Pacing Problem, Inappropriate/Inadequate Shock/Stimulation, Device Operates Differently Than Expected |
| 2018-01-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-08 | Malfunction | None | High impedance, Ambient Noise Problem |
| 2018-01-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-04 | Injury | None | Over-Sensing, Pacing Problem, Inappropriate/Inadequate Shock/Stimulation, Ambient Noise Problem |
| 2018-01-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-01 | Malfunction | None | Impedance Problem |
| 2017-12-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-12-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-12-22 | Injury | None | Electrical /Electronic Property Problem, High impedance, Over-Sensing, Pacing Problem, Unexpected Therapeutic Results, Ambient Noise Problem |
| 2017-12-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-12-19 | Malfunction | None | Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2017-12-19 | Malfunction | None | Fitting Problem |
| 2017-12-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-12-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-12-08 | Injury | None | Device Operates Differently Than Expected |
| 2017-12-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-12-01 | Malfunction | None | High impedance, Pacing Problem |
| 2017-11-30 | Malfunction | None | High impedance, Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2017-11-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-11-28 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2017-11-27 | Injury | None | Over-Sensing |
| 2017-11-21 | Malfunction | None | Low impedance, Device Sensing Problem |
| 2017-11-21 | Malfunction | None | High impedance |
| 2017-11-21 | Malfunction | None | High impedance |
| 2017-11-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-11-15 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2017-11-15 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2017-11-15 | Malfunction | None | Failure to Capture, High impedance, Over-Sensing, Ambient Noise Problem, Capturing Problem |
| 2017-11-14 | Malfunction | None | Premature Discharge of Battery, Device Displays Incorrect Message |
| 2017-11-13 | Malfunction | None | High impedance |
| 2017-11-09 | Malfunction | None | High impedance |
| 2017-11-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-11-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-11-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-11-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-11-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-11-02 | Malfunction | None | Over-Sensing, Ambient Noise Problem, Impedance Problem |
| 2017-10-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-27 | Injury | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2017-10-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-24 | Injury | None | High impedance, Migration or Expulsion of Device, Device Operates Differently Than Expected, Migration |
| 2017-10-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-19 | Injury | None | Failure to Capture, High impedance, Defibrillation/Stimulation Problem |
| 2017-10-17 | Injury | None | Device Operates Differently Than Expected |
| 2017-10-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-11 | Malfunction | None | Over-Sensing, Pacing Problem, Ambient Noise Problem, Material Integrity Problem |
| 2017-10-11 | Malfunction | None | High impedance, Over-Sensing |
| 2017-10-10 | Malfunction | None | Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2017-10-10 | Injury | None | Over-Sensing, Pacing Problem |
| 2017-10-10 | Malfunction | None | High impedance, Pocket Stimulation, Capturing Problem |
| 2017-10-09 | Injury | None | Pocket Stimulation, Capturing Problem, Adverse Event Without Identified Device or Use Problem |
| 2017-10-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-04 | Injury | None | Pacing Problem |
| 2017-10-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-01 | Injury | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2017-09-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-09-28 | Malfunction | None | Over-Sensing, Pacing Problem, Inappropriate/Inadequate Shock/Stimulation, Device Displays Incorrect Message, Ambient Noise Problem |
| 2017-09-25 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2017-09-25 | Injury | None | Pacing Problem |
| 2017-09-25 | Injury | None | Material Integrity Problem, Adverse Event Without Identified Device or Use Problem |
| 2017-09-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-09-22 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2017-09-21 | Malfunction | None | Connection Problem |
| 2017-09-20 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2017-09-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-09-15 | Malfunction | None | High impedance, Capturing Problem |
| 2017-09-15 | Injury | None | Electrical /Electronic Property Problem, Over-Sensing, Ambient Noise Problem, Impedance Problem |
| 2017-09-13 | Malfunction | None | Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2017-09-12 | Malfunction | None | Battery Problem |
| 2017-09-11 | Injury | None | Failure to Capture |
| 2017-09-09 | Injury | None | Premature Discharge of Battery |
| 2017-09-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-09-05 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2017-09-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-09-01 | Malfunction | None | Device Alarm System, High impedance, Over-Sensing, Ambient Noise Problem |
| 2017-08-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-08-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-08-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-08-22 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2017-08-17 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-08-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-08-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-08-15 | Malfunction | None | Over-Sensing, Ambient Noise Problem |
| 2017-08-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-08-10 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2017-08-10 | Injury | None | Failure to Capture, High impedance |
| 2017-08-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-08-03 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2017-08-01 | Injury | None | Device Operates Differently Than Expected |
| 2017-07-27 | Malfunction | None | Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2017-07-25 | Injury | None | Migration or Expulsion of Device |
| 2017-07-23 | Malfunction | None | Failure to Capture, Over-Sensing, Ambient Noise Problem |
| 2017-07-20 | Injury | None | Device Operates Differently Than Expected |
| 2017-07-20 | Injury | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2017-07-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-07-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-07-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-07-14 | Injury | None | Pacing Problem, Device Operates Differently Than Expected |
| 2017-07-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-07-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-07-13 | Malfunction | None | High impedance |
| 2017-07-12 | Injury | None | Electrical /Electronic Property Problem, Over-Sensing, Ambient Noise Problem, Capturing Problem, Device Operates Differently Than Expected |
| 2017-07-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-07-05 | Injury | None | Device Operates Differently Than Expected |
| 2017-07-05 | Malfunction | None | High impedance, Improper Alarm |
| 2017-07-01 | Malfunction | None | Failure to Capture, High impedance |
| 2017-06-30 | Malfunction | None | Failure to Capture, Connection Problem |
| 2017-06-25 | Malfunction | None | High impedance |
| 2017-06-24 | Injury | None | Device Operates Differently Than Expected |
| 2017-06-22 | Malfunction | None | High impedance |
| 2017-06-20 | Injury | None | Failure to Capture, Over-Sensing, Capturing Problem |
| 2017-06-20 | Injury | None | Over-Sensing, Pacing Problem, Inappropriate/Inadequate Shock/Stimulation, Ambient Noise Problem |
| 2017-06-20 | Injury | None | Over-Sensing, Pacing Problem, Ambient Noise Problem, Adverse Event Without Identified Device or Use Problem |
| 2017-06-08 | Injury | None | Over-Sensing, Pacing Problem |
| 2017-06-07 | 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 | Over-Sensing, Pacing Problem, Inappropriate/Inadequate Shock/Stimulation, Ambient Noise Problem |
| 2017-06-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-05-24 | Malfunction | None | High impedance |
| 2017-05-24 | Malfunction | None | High impedance |
| 2017-05-19 | Injury | None | Low impedance, Device Displays Incorrect Message |
| 2017-05-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-05-19 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2017-05-17 | Injury | None | Pacing Problem, Inappropriate/Inadequate Shock/Stimulation |
| 2017-05-12 | Injury | None | Over-Sensing, Pacing Problem |
| 2017-05-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-05-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-05-09 | Malfunction | None | Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2017-05-08 | Malfunction | None | Over-Sensing, Ambient Noise Problem |
| 2017-05-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-05-06 | Malfunction | None | High impedance |
| 2017-05-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-05-02 | Malfunction | None | Electrical /Electronic Property Problem, High impedance, Over-Sensing, Ambient Noise Problem |
| 2017-05-01 | Injury | None | Pocket Stimulation |
| 2017-04-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-04-24 | Injury | None | Premature Discharge of Battery |
| 2017-04-23 | Injury | None | Device Operates Differently Than Expected |
| 2017-04-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-04-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-04-12 | 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 | Failure to Capture, Capturing Problem |
| 2017-04-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-04-05 | Injury | None | Electrical /Electronic Property Problem |
| 2017-04-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-04-04 | Injury | None | Device Operates Differently Than Expected, Adverse Event Without Identified Device or Use Problem |
| 2017-04-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-27 | Malfunction | None | Communication or Transmission Problem |
| 2017-03-25 | Malfunction | None | High impedance |
| 2017-03-24 | Malfunction | None | Over-Sensing, Inappropriate/Inadequate Shock/Stimulation, Ambient Noise Problem |
| 2017-03-22 | Malfunction | None | High impedance, Over-Sensing |
| 2017-03-22 | Injury | None | Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2017-03-18 | Malfunction | None | Defibrillation/Stimulation Problem, Under-Sensing |
| 2017-03-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-17 | Injury | None | Pacing Problem, Device Operates Differently Than Expected |
| 2017-03-16 | Malfunction | None | High impedance |
| 2017-03-14 | Injury | None | Over-Sensing, Inappropriate/Inadequate Shock/Stimulation, Ambient Noise Problem, Device Operates Differently Than Expected |
| 2017-03-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-10 | Malfunction | None | High impedance |
| 2017-03-09 | Malfunction | None | High impedance, Connection Problem, Material Integrity Problem |
| 2017-03-07 | Injury | None | Device Operates Differently Than Expected |
| 2017-03-07 | Injury | None | Pacing Problem |
| 2017-03-06 | Injury | None | Capturing Problem |
| 2017-03-06 | Malfunction | None | High impedance, Pocket Stimulation, Capturing Problem |
| 2017-03-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-05 | Malfunction | None | High impedance |
| 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 | Injury | None | High impedance |
| 2017-03-01 | Malfunction | None | High impedance |
| 2017-02-23 | Malfunction | None | Device Alarm System, High impedance |
| 2017-02-21 | Malfunction | None | High impedance, Ambient Noise Problem |
| 2017-02-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-02-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-02-13 | Malfunction | None | Electrical /Electronic Property Problem, High impedance, Over-Sensing, Ambient Noise Problem |
| 2017-02-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-02-11 | Malfunction | None | High impedance |
| 2017-02-09 | Malfunction | None | Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2017-02-09 | Injury | None | Device Operates Differently Than Expected |
| 2017-02-08 | Injury | None | Failure to Capture, Capturing Problem, Impedance Problem |
| 2017-02-08 | Injury | None | Device Operates Differently Than Expected |
| 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 | Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2017-02-03 | Malfunction | None | High impedance |
| 2017-02-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-30 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-26 | Malfunction | None | Fitting Problem |
| 2017-01-23 | Malfunction | None | Device Alarm System, Impedance Problem |
| 2017-01-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-17 | Injury | None | Failure to Capture, Low impedance, Capturing Problem |
| 2017-01-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-16 | Malfunction | None | High impedance |
| 2017-01-12 | Malfunction | None | Over-Sensing, Ambient Noise Problem |
| 2017-01-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-01 | Malfunction | None | Electrical /Electronic Property Problem, High impedance, Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2016-12-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-12-25 | Malfunction | None | Pacing Problem, Inappropriate/Inadequate Shock/Stimulation |
| 2016-12-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-12-20 | Injury | None | High impedance |
| 2016-12-14 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem, Capturing Problem |
| 2016-12-09 | Injury | None | Device Displays Incorrect Message |
| 2016-12-09 | Malfunction | None | High impedance |
| 2016-12-05 | Malfunction | None | Pacing Problem |
| 2016-12-02 | Injury | None | Failure to Capture |
| 2016-11-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-11-28 | Malfunction | None | Ambient Noise Problem |
| 2016-11-22 | Injury | None | Failure to Capture, High impedance, Over-Sensing, Inappropriate/Inadequate Shock/Stimulation, Ambient Noise Problem |
| 2016-11-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-11-17 | Malfunction | None | Pacing Problem, Inappropriate/Inadequate Shock/Stimulation |
| 2016-11-14 | Injury | None | Failure to Capture, High impedance, Defective Device, Ambient Noise Problem, Device Sensing Problem |
| 2016-11-11 | Malfunction | None | High impedance |
| 2016-11-11 | Malfunction | None | High impedance |
| 2016-11-09 | Malfunction | None | Electrical /Electronic Property Problem, High impedance, Over-Sensing, Ambient Noise Problem |
| 2016-11-06 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation |
| 2016-11-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-11-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-11-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-11-03 | Injury | None | Device Operates Differently Than Expected |
| 2016-11-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-11-02 | Death | None | Under-Sensing |
| 2016-11-01 | Malfunction | None | Device Displays Incorrect Message |
| 2016-10-31 | Malfunction | None | Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2016-10-26 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2016-10-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-10-20 | Injury | None | Device Contamination With Biological Material, Adverse Event Without Identified Device or Use Problem |
| 2016-10-18 | Injury | None | Over-Sensing |
| 2016-10-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-10-13 | Injury | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2016-10-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-10-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-10-04 | Malfunction | None | High impedance, Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2016-10-01 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2016-09-30 | Injury | None | Over-Sensing, Pacing Problem |
| 2016-09-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-09-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-09-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-09-26 | Malfunction | None | Over-Sensing |
| 2016-09-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-09-14 | Injury | None | High impedance, Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2016-09-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-09-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-09-14 | Malfunction | None | Over-Sensing, Ambient Noise Problem, Device Operates Differently Than Expected, Impedance Problem |
| 2016-09-13 | Malfunction | None | High impedance |
| 2016-09-09 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-09-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-09-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-09-01 | Injury | None | Over-Sensing, Pacing Problem, Inappropriate/Inadequate Shock/Stimulation |
| 2016-08-29 | Malfunction | None | High impedance |
| 2016-08-24 | Malfunction | None | Over-Sensing, Ambient Noise Problem |
| 2016-08-24 | Injury | None | Device Operates Differently Than Expected |
| 2016-08-22 | Injury | None | Migration or Expulsion of Device |
| 2016-08-19 | Injury | None | Over-Sensing, Pacing Problem |
| 2016-08-19 | Malfunction | None | High impedance, Capturing Problem |
| 2016-08-18 | Injury | None | Pacing Problem, Failure to Convert Rhythm, Device Operates Differently Than Expected |
| 2016-08-18 | Malfunction | None | Electrical /Electronic Property Problem |
| 2016-08-16 | Injury | None | Premature Discharge of Battery, Device Operates Differently Than Expected |
| 2016-08-15 | Malfunction | None | Over-Sensing, Fitting Problem |
| 2016-08-14 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation |
| 2016-08-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-08-10 | Malfunction | None | High impedance |
| 2016-08-10 | Death | None | Electrical /Electronic Property Problem, Over-Sensing, Failure to Sense, Inappropriate/Inadequate Shock/Stimulation, Device Sensing Problem |
| 2016-08-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-08-08 | Injury | None | Device Operates Differently Than Expected |
| 2016-08-08 | Injury | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2016-08-01 | Injury | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2016-08-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-07-29 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2016-07-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-07-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-07-25 | Malfunction | None | Device Displays Incorrect Message |
| 2016-07-22 | Malfunction | None | Over-Sensing, Inappropriate/Inadequate Shock/Stimulation, Ambient Noise Problem |
| 2016-07-22 | Injury | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2016-07-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-07-20 | Malfunction | None | High impedance |
| 2016-07-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-07-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-07-14 | Injury | None | Device Alarm System, High impedance, Connection Problem |
| 2016-07-13 | Malfunction | None | Device Alarm System, High impedance, Over-Sensing, Ambient Noise Problem |
| 2016-07-11 | Malfunction | None | Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2016-07-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-07-08 | Malfunction | None | Device Displays Incorrect Message |
| 2016-07-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-07-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-07-06 | Malfunction | None | Over-Sensing |
| 2016-07-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-06-30 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2016-06-29 | Malfunction | None | High impedance |
| 2016-06-10 | Injury | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2016-06-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-06-08 | Malfunction | None | Fitting Problem |
| 2016-06-06 | Injury | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2016-05-17 | Injury | None | Failure to Capture |
| 2016-05-15 | Injury | None | Pacing Problem, Defibrillation/Stimulation Problem |
| 2016-05-12 | Malfunction | None | High impedance |
| 2016-05-01 | Malfunction | None | High impedance |
| 2016-03-04 | Malfunction | None | High impedance, Over-Sensing, Pacing Problem, Ambient Noise Problem, Connection Problem |
| 2016-03-01 | Malfunction | None | High impedance |
| 2016-02-11 | Malfunction | None | Over-Sensing, Inappropriate/Inadequate Shock/Stimulation, Ambient Noise Problem |
| 2016-01-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2015-08-20 | Malfunction | None | Device Sensing Problem, Impedance Problem |
| 2015-08-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2015-08-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2015-07-20 | Malfunction | None | Device Operates Differently Than Expected |
| 2015-06-15 | Malfunction | None | Under-Sensing |
| 2015-04-16 | Malfunction | None | Over-Sensing, Ambient Noise Problem |
| 2015-02-27 | Malfunction | None | Inappropriate/Inadequate Shock/Stimulation, Under-Sensing |
| 2014-02-28 | Malfunction | None | Fitting Problem |
| 2014-02-27 | Malfunction | None | Connection Problem, Impedance Problem |
| 2014-02-21 | Malfunction | None | High impedance, Fitting Problem, Device Sensing Problem |