IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
This device is manufactured by BOSTON SCIENTIFIC, BOSTON SCIENTIFIC CORPORATION, GUIDANT CRM CLONMEL IRELAND.
The following problems were reported about this device:
| Date | Event Type | Patient Problem | Device Problem |
|---|---|---|---|
| 2024-07-11 | Injury | Syncope/Fainting | Incorrect, Inadequate or Imprecise Result or Readings |
| 2024-07-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-06-25 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-06-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2024-06-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings |
| 2024-05-22 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2024-05-09 | Injury | No Clinical Signs, Symptoms or Conditions | Defective Device |
| 2024-05-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Low impedance |
| 2024-05-01 | Injury | Device Overstimulation of Tissue | Incorrect, Inadequate or Imprecise Result or Readings |
| 2024-04-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Over-Sensing, Battery Problem, High Capture Threshold |
| 2024-04-28 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2024-04-26 | Injury | No Clinical Signs, Symptoms or Conditions | Defective Device |
| 2024-04-23 | Injury | Device Overstimulation of Tissue | Incorrect, Inadequate or Imprecise Result or Readings |
| 2024-04-22 | Injury | Discomfort | Incorrect, Inadequate or Imprecise Result or Readings, Interrogation Problem |
| 2024-04-22 | Injury | Device Overstimulation of Tissue | Signal Artifact/Noise, Over-Sensing, Incorrect, Inadequate or Imprecise Result or Readings, Inappropriate or Unexpected Reset |
| 2024-04-21 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery, Battery Problem |
| 2024-04-17 | Injury | Discomfort | Incorrect, Inadequate or Imprecise Result or Readings, Interrogation Problem |
| 2024-04-16 | Injury | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings |
| 2024-04-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Signal Artifact/Noise, Over-Sensing, Under-Sensing |
| 2024-04-11 | Malfunction | Fall | Signal Artifact/Noise, High impedance, Over-Sensing, Defective Device |
| 2024-04-09 | Injury | No Clinical Signs, Symptoms or Conditions | Failure to Capture, Incorrect, Inadequate or Imprecise Result or Readings |
| 2024-04-02 | Injury | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings |
| 2024-03-27 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2024-03-26 | Injury | Wound Dehiscence, Purulent Discharge, Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2024-03-25 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2024-03-18 | Malfunction | Bradycardia | Signal Artifact/Noise, Over-Sensing, Pacing Problem |
| 2024-02-26 | Injury | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings |
| 2024-02-21 | Injury | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings |
| 2024-02-20 | Injury | Syncope/Fainting | Signal Artifact/Noise, Pacing Problem, Incorrect, Inadequate or Imprecise Result or Readings, Inappropriate or Unexpected Reset |
| 2024-02-16 | Injury | Device Overstimulation of Tissue | Pocket Stimulation, Incorrect, Inadequate or Imprecise Result or Readings, Inappropriate or Unexpected Reset |
| 2024-02-15 | Injury | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings |
| 2024-02-15 | Injury | Dyspnea | Signal Artifact/Noise, Over-Sensing, Pacing Problem, Incorrect, Inadequate or Imprecise Result or Readings |
| 2024-02-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | Defective Device |
| 2024-01-30 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture, High Capture Threshold |
| 2024-01-25 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture, Over-Sensing, Under-Sensing, High Capture Threshold |
| 2024-01-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Battery Problem |
| 2024-01-16 | Injury | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings |
| 2024-01-08 | Injury | No Clinical Signs, Symptoms or Conditions | High impedance, High Capture Threshold |
| 2023-12-25 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance, Defective Device |
| 2023-12-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Signal Artifact/Noise, Over-Sensing |
| 2023-12-06 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2023-12-05 | Injury | Bacterial Infection, Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-11-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance |
| 2023-11-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | Under-Sensing |
| 2023-10-24 | Injury | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings |
| 2023-10-23 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery, Battery Problem |
| 2023-10-14 | Injury | No Clinical Signs, Symptoms or Conditions | Defective Device |
| 2023-10-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Over-Sensing |
| 2023-09-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | Over-Sensing, Under-Sensing |
| 2023-09-28 | Injury | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings |
| 2023-09-27 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2023-09-25 | Injury | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings, Connection Problem |
| 2023-09-22 | Injury | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings, Telemetry Discrepancy, Battery Problem, Inappropriate or Unexpected Reset |
| 2023-09-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Under-Sensing |
| 2023-09-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Defective Device |
| 2023-09-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Over-Sensing |
| 2023-09-06 | Injury | No Clinical Signs, Symptoms or Conditions | Signal Artifact/Noise, High impedance, Over-Sensing |
| 2023-09-04 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2023-09-02 | Malfunction | Unspecified Heart Problem | High impedance |
| 2023-08-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance |
| 2023-08-17 | Injury | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings, Inappropriate or Unexpected Reset |
| 2023-08-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance |
| 2023-08-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings |
| 2023-08-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Interrogation Problem |
| 2023-07-27 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2023-07-25 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2023-07-18 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2023-07-13 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-07-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Defective Device |
| 2023-07-04 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2023-06-24 | Injury | Device Overstimulation of Tissue | High impedance, Pocket Stimulation |
| 2023-06-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Signal Artifact/Noise, Over-Sensing |
| 2023-06-10 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery, Incorrect, Inadequate or Imprecise Result or Readings, Interrogation Problem |
| 2023-06-01 | Malfunction | Asystole | Signal Artifact/Noise, Over-Sensing, Pacing Problem, Failure to Read Input Signal, Low impedance, High Capture Threshold |
| 2023-05-30 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-05-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | False Positive Result, Failure to Read Input Signal, Under-Sensing |
| 2023-04-15 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2023-04-12 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery, Battery Problem |
| 2023-04-12 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2023-04-11 | Injury | Syncope/Fainting | Adverse Event Without Identified Device or Use Problem |
| 2023-04-05 | Injury | Unspecified Infection, Pocket Erosion | Adverse Event Without Identified Device or Use Problem |
| 2023-04-05 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery, Battery Problem |
| 2023-03-21 | Malfunction | Unspecified Heart Problem | Signal Artifact/Noise, High impedance |
| 2023-03-20 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2023-03-12 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery, Incorrect, Inadequate or Imprecise Result or Readings |
| 2023-03-08 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery, Battery Problem |
| 2023-03-06 | Injury | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings |
| 2023-02-28 | Injury | Dyspnea, Unspecified Heart Problem | Incorrect, Inadequate or Imprecise Result or Readings, Interrogation Problem |
| 2023-02-16 | Injury | Discomfort | Incorrect, Inadequate or Imprecise Result or Readings |
| 2023-02-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Defective Device |
| 2023-02-02 | Malfunction | Bradycardia | Failure to Capture |
| 2023-01-17 | Injury | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings |
| 2023-01-17 | Injury | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings, Data Problem |
| 2023-01-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Defective Device |
| 2022-12-20 | Injury | Malaise | Telemetry Discrepancy, Defective Device |
| 2022-12-19 | Injury | None | Incorrect, Inadequate or Imprecise Result or Readings |
| 2022-12-13 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2022-12-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-12-09 | Injury | None | Incorrect, Inadequate or Imprecise Result or Readings |
| 2022-12-07 | Injury | None | Incorrect, Inadequate or Imprecise Result or Readings |
| 2022-12-06 | Malfunction | None | High impedance |
| 2022-12-04 | Injury | None | Over-Sensing, Pacing Problem, Incorrect, Inadequate or Imprecise Result or Readings, Interrogation Problem |
| 2022-11-28 | Injury | None | Premature Discharge of Battery |
| 2022-11-22 | Malfunction | None | Defective Device |
| 2022-11-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance, Device Sensing Problem |
| 2022-11-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Signal Artifact/Noise, Over-Sensing |
| 2022-11-07 | Malfunction | None | Defective Device |
| 2022-11-07 | Malfunction | None | Defective Device |
| 2022-11-04 | Injury | None | Premature Discharge of Battery |
| 2022-10-29 | Injury | None | Failure to Capture, Over-Sensing, Pacing Problem, Under-Sensing |
| 2022-10-26 | Malfunction | None | Defective Device |
| 2022-10-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Signal Artifact/Noise, High impedance |
| 2022-10-19 | Injury | None | Premature Discharge of Battery |
| 2022-10-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-09-12 | Injury | None | Premature Discharge of Battery |
| 2022-09-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-09-01 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2022-08-23 | Malfunction | None | Incorrect, Inadequate or Imprecise Result or Readings |
| 2022-08-23 | Injury | None | Premature Discharge of Battery, Battery Problem |
| 2022-08-16 | Injury | None | Premature Discharge of Battery |
| 2022-08-11 | Malfunction | None | High impedance, Defective Device |
| 2022-08-11 | Injury | None | Premature Discharge of Battery |
| 2022-08-01 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2022-08-01 | Injury | None | Signal Artifact/Noise, High impedance, Over-Sensing, Pacing Problem |
| 2022-07-29 | Malfunction | None | Signal Artifact/Noise, High impedance, Over-Sensing, Connection Problem |
| 2022-07-28 | Malfunction | None | Defective Device |
| 2022-07-20 | Malfunction | None | Defective Device |
| 2022-07-14 | Injury | None | Premature Discharge of Battery |
| 2022-07-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-07-01 | Injury | None | Premature Discharge of Battery, Battery Problem |
| 2022-03-24 | Injury | None | Signal Artifact/Noise, Over-Sensing, Pacing Problem, Inaccurate Synchronization, Under-Sensing |
| 2022-03-24 | Malfunction | None | Incorrect, Inadequate or Imprecise Result or Readings |
| 2022-03-22 | Injury | None | Pocket Stimulation, Incorrect, Inadequate or Imprecise Result or Readings |
| 2022-03-21 | Malfunction | None | Incorrect, Inadequate or Imprecise Result or Readings |
| 2022-03-18 | Malfunction | None | Premature Discharge of Battery |
| 2022-03-07 | Injury | None | Premature Discharge of Battery |
| 2022-03-07 | Injury | None | Premature Discharge of Battery |
| 2022-03-04 | Malfunction | None | Defective Device |
| 2022-03-02 | Malfunction | None | Defective Device |
| 2022-03-01 | Injury | None | Incorrect, Inadequate or Imprecise Result or Readings |
| 2022-02-25 | Malfunction | None | Premature Discharge of Battery |
| 2022-02-23 | Malfunction | None | High impedance |
| 2022-02-23 | Injury | None | Premature Discharge of Battery, Telemetry Discrepancy |
| 2022-02-22 | Injury | None | High impedance |
| 2022-02-21 | Injury | None | Premature Discharge of Battery |
| 2022-02-18 | Malfunction | None | Over-Sensing |
| 2022-02-18 | Malfunction | None | Defective Device |
| 2022-02-11 | Injury | None | Premature Discharge of Battery |
| 2022-02-10 | Injury | None | Telemetry Discrepancy |
| 2022-02-09 | Injury | None | Premature Discharge of Battery, Battery Problem |
| 2022-02-09 | Malfunction | None | High impedance |
| 2022-02-08 | Injury | None | Premature Discharge of Battery, Battery Problem |
| 2022-02-07 | Injury | None | Premature Discharge of Battery, Battery Problem |
| 2022-02-05 | Injury | None | Incorrect, Inadequate or Imprecise Result or Readings |
| 2022-02-04 | Malfunction | None | Pacing Problem |
| 2022-02-04 | Injury | None | Premature Discharge of Battery, Battery Problem |
| 2022-02-03 | Malfunction | None | Defective Device |
| 2022-02-02 | Malfunction | None | Defective Device |
| 2022-01-28 | Malfunction | None | High impedance |
| 2022-01-27 | Injury | None | Premature Discharge of Battery |
| 2022-01-25 | Malfunction | None | Defective Device |
| 2022-01-25 | Malfunction | None | Defective Device |
| 2022-01-24 | Injury | None | Premature Discharge of Battery, Battery Problem |
| 2022-01-24 | Malfunction | None | Defective Device |
| 2022-01-21 | Malfunction | None | High impedance |
| 2022-01-20 | Malfunction | None | Defective Device |
| 2022-01-17 | Injury | None | Premature Discharge of Battery, Battery Problem |
| 2022-01-14 | Injury | None | Premature Discharge of Battery |
| 2022-01-13 | Injury | None | Premature Discharge of Battery |
| 2022-01-10 | Injury | None | Premature Discharge of Battery, Defective Device |
| 2022-01-07 | Malfunction | None | Premature Discharge of Battery, Incorrect, Inadequate or Imprecise Result or Readings, Inappropriate or Unexpected Reset |
| 2022-01-06 | Injury | None | Premature Discharge of Battery, Pacing Problem, Inappropriate or Unexpected Reset |
| 2022-01-03 | Injury | None | Premature Discharge of Battery, Battery Problem |
| 2021-12-31 | Malfunction | None | Defective Device |
| 2021-12-15 | Malfunction | None | Premature Discharge of Battery, Battery Problem |
| 2021-11-24 | Malfunction | None | Defective Device |
| 2021-11-23 | Malfunction | None | Defective Device |
| 2021-11-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2021-10-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2021-10-15 | Malfunction | None | Defective Device |
| 2021-07-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Defective Device |
| 2021-07-01 | Injury | None | Premature Discharge of Battery, Battery Problem |
| 2021-05-06 | Malfunction | None | Defective Device |
| 2021-05-05 | Malfunction | None | Defective Device |
| 2021-05-03 | Malfunction | Insufficient Information | Over-Sensing, Defective Device |
| 2021-01-21 | Malfunction | None | Signal Artifact/Noise, High impedance |
| 2020-05-01 | Injury | None | Signal Artifact/Noise, High impedance, Over-Sensing, Pacing Problem |
| 2020-02-26 | Injury | None | Signal Artifact/Noise, High impedance, Over-Sensing, Device Sensing Problem |
| 2019-10-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Use of Device Problem, Defective Device |
| 2019-09-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Over-Sensing, Failure to Read Input Signal, Device Sensing Problem |
| 2019-08-16 | Injury | None | Premature Discharge of Battery |
| 2019-08-16 | Injury | None | Failure to Capture |
| 2019-08-16 | Malfunction | None | False Positive Result, High impedance, Over-Sensing |
| 2019-07-21 | Injury | None | Failure to Capture, High impedance |
| 2019-07-20 | Malfunction | None | Over-Sensing, Low impedance |
| 2019-07-18 | Malfunction | None | Device Displays Incorrect Message |
| 2019-07-18 | Injury | None | Premature Discharge of Battery |
| 2019-07-17 | Injury | None | Premature Discharge of Battery, Pacing Problem, Inappropriate or Unexpected Reset, Interrogation Problem |
| 2019-07-12 | Injury | None | Premature Discharge of Battery |
| 2019-07-09 | Injury | None | Premature Discharge of Battery |
| 2019-07-06 | Injury | None | Premature Discharge of Battery, Device Displays Incorrect Message |
| 2019-07-03 | Injury | None | Premature Discharge of Battery |
| 2019-06-27 | Injury | None | Migration |
| 2019-06-26 | Injury | None | Premature Discharge of Battery |
| 2019-06-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-20 | Injury | None | Premature Discharge of Battery |
| 2019-06-19 | Injury | None | Premature Discharge of Battery |
| 2019-06-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-18 | Injury | None | Premature Discharge of Battery |
| 2019-06-14 | Injury | None | Premature Discharge of Battery, Failure to Capture, High impedance |
| 2019-06-14 | Injury | None | Premature Discharge of Battery |
| 2019-06-09 | Injury | None | Premature Discharge of Battery, Defective Device |
| 2019-06-06 | Injury | None | Premature Discharge of Battery |
| 2019-06-04 | Malfunction | None | Defective Device |
| 2019-06-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-30 | Injury | None | Defective Device, Battery Problem |
| 2019-05-29 | Malfunction | None | High impedance |
| 2019-05-28 | Injury | None | Premature Discharge of Battery |
| 2019-05-27 | Injury | None | Patient-Device Incompatibility |
| 2019-05-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-23 | Injury | None | Over-Sensing, Unexpected Therapeutic Results |
| 2019-05-23 | Malfunction | None | Defective Device |
| 2019-05-23 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-22 | Malfunction | None | High impedance, Pacing Problem, Pocket Stimulation |
| 2019-05-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-20 | Malfunction | None | Failure to Capture, Over-Sensing, Device Sensing Problem, Material Integrity Problem |
| 2019-05-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance, Over-Sensing, Under-Sensing, Defective Device |
| 2019-05-13 | Injury | None | Premature Discharge of Battery |
| 2019-05-10 | Injury | None | High impedance |
| 2019-05-08 | Injury | None | Premature Discharge of Battery |
| 2019-05-08 | Injury | None | Premature Discharge of Battery |
| 2019-05-07 | Malfunction | None | Defective Device |
| 2019-05-07 | Injury | None | Premature Discharge of Battery |
| 2019-05-06 | Injury | None | Premature Discharge of Battery, Failure to Capture |
| 2019-05-02 | Injury | None | Patient-Device Incompatibility |
| 2019-05-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-02 | Injury | None | Premature Discharge of Battery |
| 2019-05-01 | Injury | None | Premature Discharge of Battery |
| 2019-05-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-26 | Malfunction | None | High impedance, Over-Sensing |
| 2019-04-25 | Injury | None | High impedance, Over-Sensing, Pacing Problem |
| 2019-04-24 | Injury | None | Defective Device |
| 2019-04-24 | Injury | None | Premature Discharge of Battery |
| 2019-04-23 | Injury | None | Defective Device |
| 2019-04-22 | Malfunction | None | High impedance |
| 2019-04-16 | Malfunction | None | Premature Discharge of Battery |
| 2019-04-16 | Injury | None | Premature Discharge of Battery |
| 2019-04-15 | Injury | None | Premature Discharge of Battery |
| 2019-04-15 | Injury | None | Off-Label Use, Adverse Event Without Identified Device or Use Problem |
| 2019-04-12 | Injury | None | Device Displays Incorrect Message |
| 2019-04-11 | Injury | None | Defective Device, Device Sensing Problem |
| 2019-04-08 | Injury | None | Defective Device |
| 2019-04-05 | Injury | None | Failure to Capture, Pacing Problem, High Capture Threshold |
| 2019-04-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-03 | Malfunction | None | Premature Discharge of Battery |
| 2019-04-03 | Injury | None | Premature Discharge of Battery |
| 2019-04-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-02 | Injury | None | Premature Discharge of Battery |
| 2019-04-02 | Malfunction | None | High impedance, Over-Sensing, Pacing Problem |
| 2019-03-27 | Malfunction | None | Defective Device |
| 2019-03-25 | Injury | None | Over-Sensing, Pacing Problem, Device Sensing Problem |
| 2019-03-25 | Injury | None | Premature Discharge of Battery, Defective Device |
| 2019-03-24 | Injury | None | High impedance, Over-Sensing, Pacing Problem, High Capture Threshold |
| 2019-03-19 | Malfunction | Insufficient Information | High impedance |
| 2019-03-18 | Injury | None | Patient-Device Incompatibility |
| 2019-03-15 | Injury | None | Premature Discharge of Battery |
| 2019-03-15 | Injury | None | Premature Discharge of Battery |
| 2019-03-15 | Malfunction | None | Premature Discharge of Battery |
| 2019-03-15 | Injury | None | Defective Device |
| 2019-03-11 | Malfunction | None | Defective Device |
| 2019-03-10 | Injury | None | Defective Device, Adverse Event Without Identified Device or Use Problem |
| 2019-03-08 | Injury | None | Premature Discharge of Battery |
| 2019-03-06 | Malfunction | None | Premature Discharge of Battery, Device Sensing Problem, High Capture Threshold |
| 2019-03-01 | Injury | None | Premature Discharge of Battery |
| 2019-02-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-13 | Malfunction | None | High impedance |
| 2019-02-08 | Injury | None | Defective Device |
| 2019-02-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-07 | Injury | None | Failure to Capture |
| 2019-02-06 | Malfunction | None | Signal Artifact/Noise, Failure to Capture, High impedance, Device Sensing Problem |
| 2019-02-05 | Injury | None | Premature Discharge of Battery |
| 2019-02-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-05 | Injury | None | Premature Discharge of Battery |
| 2019-02-02 | Malfunction | None | Over-Sensing |
| 2019-02-01 | Malfunction | None | High impedance, Over-Sensing |
| 2019-01-31 | Malfunction | None | High impedance, Over-Sensing, Pacing Problem, Device Sensing Problem, High Capture Threshold |
| 2019-01-29 | Injury | None | Patient-Device Incompatibility |
| 2019-01-26 | Malfunction | None | High impedance, Over-Sensing |
| 2019-01-25 | Malfunction | None | Failure to Capture, Over-Sensing, Failure to Select Signal |
| 2019-01-24 | Malfunction | None | High impedance, Device Sensing Problem |
| 2019-01-22 | Injury | None | Defective Device |
| 2019-01-21 | Injury | None | High impedance |
| 2019-01-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-10 | Injury | None | Premature Discharge of Battery |
| 2019-01-10 | Injury | None | Failure to Capture, High impedance |
| 2019-01-07 | Malfunction | None | Device Displays Incorrect Message |
| 2019-01-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-01 | Injury | None | Premature Discharge of Battery |
| 2019-01-01 | Malfunction | None | Failure to Capture, High impedance, Failure to Select Signal, High Capture Threshold |
| 2018-12-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-12-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-12-27 | Malfunction | None | Defective Device |
| 2018-12-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | Signal Artifact/Noise, High impedance, Over-Sensing, Device Sensing Problem |
| 2018-12-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-12-18 | Injury | None | Premature Discharge of Battery |
| 2018-12-18 | Injury | None | Off-Label Use, Adverse Event Without Identified Device or Use Problem |
| 2018-12-14 | Injury | None | Premature Discharge of Battery |
| 2018-12-13 | Injury | None | High impedance, Over-Sensing, Pacing Problem, Device Sensing Problem |
| 2018-12-12 | Malfunction | None | Defective Device |
| 2018-12-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance, Over-Sensing, Defective Device |
| 2018-12-06 | Injury | None | Premature Discharge of Battery |
| 2018-12-06 | Injury | None | Premature Discharge of Battery |
| 2018-12-05 | Injury | None | High impedance, High Capture Threshold |
| 2018-12-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-12-03 | Injury | None | Over-Sensing, Pacing Problem, Low impedance, Device Sensing Problem |
| 2018-12-01 | Malfunction | None | High impedance |
| 2018-12-01 | Injury | None | High impedance, Pacing Problem, High Capture Threshold |
| 2018-11-28 | Malfunction | None | Failure to Capture, Over-Sensing, Use of Device Problem, Device Sensing Problem, Impedance Problem |
| 2018-11-25 | Malfunction | None | Failure to Capture, High impedance, Over-Sensing, Device Sensing Problem |
| 2018-11-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-19 | Malfunction | None | High impedance |
| 2018-11-19 | Injury | None | High impedance, Over-Sensing, Pacing Problem, Device Sensing Problem |
| 2018-11-19 | Malfunction | None | Signal Artifact/Noise, High impedance, Over-Sensing, Pacing Problem, Device Sensing Problem |
| 2018-11-18 | Injury | None | Over-Sensing, Pacing Problem, Device Sensing Problem |
| 2018-11-16 | Injury | None | Premature Discharge of Battery |
| 2018-11-15 | Malfunction | None | High impedance, Device Sensing Problem |
| 2018-11-14 | Injury | None | Premature Discharge of Battery |
| 2018-11-13 | Injury | None | Inappropriate or Unexpected Reset |
| 2018-11-12 | Malfunction | None | High impedance, Over-Sensing, Device Sensing Problem |
| 2018-11-09 | Injury | None | Premature Discharge of Battery |
| 2018-11-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-07 | Injury | None | Premature Discharge of Battery |
| 2018-11-06 | Injury | None | High impedance |
| 2018-11-05 | Malfunction | None | High impedance, Over-Sensing, Device Sensing Problem |
| 2018-11-03 | Injury | None | Low impedance |
| 2018-11-02 | Injury | None | Premature Discharge of Battery |
| 2018-11-01 | Injury | None | 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 |
| 2018-10-30 | Malfunction | None | Over-Sensing, Pacing Problem, Device Sensing Problem |
| 2018-10-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-29 | Malfunction | None | High impedance, Device Sensing Problem |
| 2018-10-29 | Injury | None | Premature Discharge of Battery |
| 2018-10-26 | Malfunction | None | High impedance |
| 2018-10-24 | Malfunction | None | Defective Device |
| 2018-10-22 | Injury | None | Premature Discharge of Battery |
| 2018-10-22 | Injury | None | Signal Artifact/Noise, High impedance, Over-Sensing, Device Sensing Problem |
| 2018-10-20 | Injury | None | Failure to Capture, High impedance, Pacing Problem, Defective Device |
| 2018-10-20 | Malfunction | None | Over-Sensing |
| 2018-10-19 | Injury | None | Premature Discharge of Battery |
| 2018-10-17 | Injury | None | Over-Sensing, Device Sensing Problem |
| 2018-10-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-16 | Malfunction | None | Signal Artifact/Noise, Over-Sensing, Low impedance |
| 2018-10-15 | Malfunction | None | High impedance |
| 2018-10-15 | Injury | None | Connection Problem |
| 2018-10-09 | Injury | None | Premature Discharge of Battery |
| 2018-10-08 | Injury | None | Premature Discharge of Battery |
| 2018-10-08 | Injury | None | Premature Discharge of Battery |
| 2018-10-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-05 | Injury | None | High impedance |
| 2018-10-05 | Injury | None | Defective Device |
| 2018-10-05 | Injury | None | Over-Sensing, Pacing Problem, Device Sensing Problem |
| 2018-10-03 | Malfunction | None | High impedance, Device Sensing Problem |
| 2018-10-01 | Malfunction | None | High impedance, Over-Sensing, Device Sensing Problem |
| 2018-09-30 | Malfunction | None | High impedance |
| 2018-09-28 | Injury | None | Premature Discharge of Battery |
| 2018-09-28 | Injury | None | Premature Discharge of Battery, Defective Device |
| 2018-09-28 | Injury | None | Failure to Capture, High impedance, Pacing Problem |
| 2018-09-27 | Malfunction | None | High impedance, Device Sensing Problem |
| 2018-09-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-25 | Malfunction | None | Device Sensing Problem |
| 2018-09-25 | Malfunction | None | Premature Discharge of Battery, Defective Device |
| 2018-09-25 | Malfunction | None | High impedance |
| 2018-09-21 | Injury | None | High impedance |
| 2018-09-19 | Injury | None | Premature Discharge of Battery |
| 2018-09-18 | Malfunction | None | High impedance, High Capture Threshold |
| 2018-09-14 | Injury | None | Off-Label Use, Adverse Event Without Identified Device or Use Problem |
| 2018-09-13 | Injury | None | Premature Discharge of Battery |
| 2018-09-13 | Injury | None | Premature Discharge of Battery, Defective Device |
| 2018-09-13 | Injury | None | Premature Discharge of Battery |
| 2018-09-12 | Injury | None | Premature Discharge of Battery, Use of Device Problem |
| 2018-09-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-07 | Injury | None | Premature Discharge of Battery |
| 2018-09-07 | Malfunction | None | Defective Device |
| 2018-09-05 | Injury | None | Premature Discharge of Battery, Off-Label Use, Device Displays Incorrect Message |
| 2018-09-05 | Malfunction | None | High impedance, Defective Device |
| 2018-09-04 | Malfunction | None | High impedance, Connection Problem |
| 2018-09-04 | Malfunction | None | Impedance Problem |
| 2018-09-04 | Injury | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2018-09-03 | Injury | None | High impedance, Over-Sensing, Pacing Problem, Device Sensing Problem |
| 2018-09-03 | Injury | None | Over-Sensing, Pacing Problem, Low impedance |
| 2018-09-01 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2018-09-01 | Malfunction | None | High impedance |
| 2018-08-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-29 | Malfunction | Insufficient Information | High impedance |
| 2018-08-29 | Malfunction | None | High impedance |
| 2018-08-28 | Injury | None | Failure to Capture, Low impedance |
| 2018-08-27 | Injury | None | Defective Device |
| 2018-08-24 | Injury | None | High impedance |
| 2018-08-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-22 | Injury | None | High impedance, Over-Sensing, Pacing Problem, Pocket Stimulation, Ambient Noise Problem, Impedance Problem |
| 2018-08-21 | Malfunction | None | High impedance, Over-Sensing, Pacing Problem, Device Sensing Problem |
| 2018-08-21 | Malfunction | None | Defective Device |
| 2018-08-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-17 | Injury | None | Premature Discharge of Battery |
| 2018-08-15 | Injury | None | Premature Discharge of Battery |
| 2018-08-14 | Injury | None | Premature Discharge of Battery |
| 2018-08-13 | Malfunction | None | Defective Device |
| 2018-08-13 | Malfunction | None | Failure to Capture, Impedance Problem |
| 2018-08-06 | Injury | None | Defective Device |
| 2018-08-06 | Injury | None | High impedance, Over-Sensing, Ambient Noise Problem, Device Sensing Problem |
| 2018-08-02 | Injury | None | Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2018-08-01 | Malfunction | None | Low impedance |
| 2018-08-01 | Injury | None | Premature Discharge of Battery |
| 2018-08-01 | Malfunction | None | Premature Discharge of Battery |
| 2018-08-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-01 | Injury | None | Over-Sensing, Device Sensing Problem, Migration |
| 2018-08-01 | Injury | None | High impedance, Over-Sensing, Pacing Problem, Device Sensing Problem |
| 2018-07-31 | Injury | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2018-07-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-30 | Malfunction | None | Device Displays Incorrect Message |
| 2018-07-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-29 | Malfunction | None | High impedance, Over-Sensing, Pacing Problem, Device Sensing Problem |
| 2018-07-27 | Malfunction | None | Over-Sensing, Ambient Noise Problem |
| 2018-07-26 | Injury | None | Defective Device |
| 2018-07-23 | Injury | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2018-07-19 | Malfunction | None | High impedance, Over-Sensing, Device Sensing Problem |
| 2018-07-19 | Malfunction | None | High impedance, Over-Sensing, Pocket Stimulation, Low impedance, Ambient Noise Problem, Device Sensing Problem, High Capture Threshold |
| 2018-07-16 | Injury | None | Premature Discharge of Battery |
| 2018-07-12 | Malfunction | None | Over-Sensing, Ambient Noise Problem |
| 2018-07-10 | Malfunction | None | Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2018-07-10 | Injury | None | Defective Device |
| 2018-07-09 | Malfunction | None | High impedance |
| 2018-07-09 | Injury | None | Over-Sensing, Pacing Problem, Ambient Noise Problem, Device Sensing Problem |
| 2018-07-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-09 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem, Impedance Problem |
| 2018-07-08 | Malfunction | None | Over-Sensing, Pocket Stimulation, Low impedance, Device Sensing Problem |
| 2018-07-06 | Malfunction | None | Communication or Transmission Problem |
| 2018-07-05 | Malfunction | None | High impedance |
| 2018-07-04 | Injury | None | Premature Discharge of Battery |
| 2018-07-03 | Injury | None | High impedance |
| 2018-07-02 | Malfunction | None | Over-Sensing, Ambient Noise Problem |
| 2018-07-02 | Injury | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2018-07-01 | Malfunction | None | High impedance, Over-Sensing, Device Sensing Problem |
| 2018-07-01 | Malfunction | None | High impedance, Ambient Noise Problem |
| 2018-07-01 | Injury | None | Device Displays Incorrect Message |
| 2018-06-29 | Malfunction | None | Pacing Problem |
| 2018-06-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-21 | Injury | None | Premature Discharge of Battery |
| 2018-06-21 | Injury | None | Premature Discharge of Battery |
| 2018-06-20 | Malfunction | None | High impedance |
| 2018-06-19 | Injury | None | Over-Sensing, Ambient Noise Problem |
| 2018-06-19 | Malfunction | None | Premature Discharge of Battery |
| 2018-06-18 | Malfunction | None | Device Displays Incorrect Message |
| 2018-06-17 | Malfunction | None | High impedance, Device Sensing Problem |
| 2018-06-16 | Malfunction | None | Failure to Capture, Pacing Problem |
| 2018-06-16 | Malfunction | None | High impedance, Over-Sensing, Unexpected Therapeutic Results, Device Sensing Problem |
| 2018-06-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-13 | Injury | None | Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2018-06-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Signal Artifact/Noise, Over-Sensing, Pacing Problem, Failure to Read Input Signal, Ambient Noise Problem, Capturing Problem, High Capture Threshold |
| 2018-06-10 | Injury | None | Over-Sensing, Under-Sensing, Capturing Problem |
| 2018-06-10 | Malfunction | None | Device Displays Incorrect Message |
| 2018-06-07 | Injury | None | Premature Discharge of Battery, Device Displays Incorrect Message |
| 2018-06-06 | Injury | None | Premature Discharge of Battery, Device Displays Incorrect Message |
| 2018-06-05 | Injury | None | High impedance |
| 2018-06-05 | Injury | None | High impedance, Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2018-06-05 | Injury | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2018-06-02 | Injury | None | Over-Sensing, Pacing Problem |
| 2018-06-01 | Malfunction | None | Failure to Capture, Under-Sensing, Device Sensing Problem |
| 2018-06-01 | Injury | None | Premature Discharge of Battery |
| 2018-05-31 | Injury | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2018-05-30 | Malfunction | None | High impedance, Pacing Problem, Capturing Problem |
| 2018-05-30 | Malfunction | None | High impedance |
| 2018-05-28 | Malfunction | None | High impedance |
| 2018-05-27 | Malfunction | None | High impedance, Over-Sensing, Device Sensing Problem |
| 2018-05-25 | Malfunction | None | Device Displays Incorrect Message |
| 2018-05-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-22 | Malfunction | None | High impedance, Ambient Noise Problem |
| 2018-05-21 | Injury | None | Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2018-05-20 | Injury | None | High impedance, Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2018-05-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Over-Sensing |
| 2018-05-18 | Injury | None | Over-Sensing, Pacing Problem, Ambient Noise Problem, Capturing Problem, Connection Problem |
| 2018-05-17 | Malfunction | None | Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2018-05-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-15 | Malfunction | None | Over-Sensing, Use of Device Problem, Ambient Noise Problem |
| 2018-05-14 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-05-12 | Malfunction | None | Fitting Problem |
| 2018-05-10 | Malfunction | None | High impedance |
| 2018-05-09 | Injury | None | Pacing Problem, Device Operates Differently Than Expected |
| 2018-05-08 | Malfunction | None | Premature Discharge of Battery |
| 2018-05-03 | Injury | None | Failure to Capture, Over-Sensing, Pacing Problem, Connection Problem |
| 2018-05-01 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2018-04-30 | Malfunction | None | Over-Sensing, Pacing Problem, Defective Device, Ambient Noise Problem |
| 2018-04-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-26 | Injury | None | Premature Discharge of Battery |
| 2018-04-24 | Injury | None | Failure to Capture, Over-Sensing, Pacing Problem, Low impedance, Ambient Noise Problem |
| 2018-04-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-23 | Malfunction | None | Pacing Problem |
| 2018-04-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-18 | Malfunction | None | High impedance, Over-Sensing, Pocket Stimulation, Under-Sensing, Ambient Noise Problem |
| 2018-04-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-17 | Malfunction | None | High impedance, Ambient Noise Problem |
| 2018-04-15 | Malfunction | None | High impedance |
| 2018-04-14 | Injury | None | Premature Discharge of Battery |
| 2018-04-11 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-04-07 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-04-07 | Malfunction | None | High impedance, Over-Sensing, Device Sensing Problem |
| 2018-04-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-03 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2018-04-01 | Malfunction | None | High impedance |
| 2018-03-30 | Malfunction | Insufficient Information | Device Alarm System, Signal Artifact/Noise, High impedance, Impedance Problem, High Capture Threshold |
| 2018-03-29 | Malfunction | None | High impedance |
| 2018-03-28 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2018-03-28 | Injury | None | Device Displays Incorrect Message, Communication or Transmission Problem, Device Operates Differently Than Expected |
| 2018-03-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-21 | Malfunction | None | High impedance, Ambient Noise Problem |
| 2018-03-20 | Malfunction | None | Device Displays Incorrect Message |
| 2018-03-20 | Injury | None | Premature Discharge of Battery |
| 2018-03-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-18 | Injury | None | Migration or Expulsion of Device |
| 2018-03-13 | Injury | None | Reset Problem |
| 2018-03-12 | Malfunction | None | Ambient Noise Problem, Connection Problem |
| 2018-03-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-05 | Malfunction | None | Low impedance, Ambient Noise Problem |
| 2018-03-05 | Injury | None | Failure to Capture, High impedance, Over-Sensing, Ambient Noise Problem |
| 2018-03-05 | Malfunction | None | Over-Sensing, Low impedance, Ambient Noise Problem |
| 2018-03-03 | Injury | None | Device Operates Differently Than Expected |
| 2018-03-02 | Injury | None | Device Operates Differently Than Expected |
| 2018-03-02 | Injury | None | Device Operates Differently Than Expected |
| 2018-03-02 | Injury | None | Over-Sensing, Pacing Problem, Use of Device Problem, Ambient Noise Problem |
| 2018-03-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-01 | Malfunction | None | High impedance, Ambient Noise Problem |
| 2018-03-01 | Injury | None | High impedance, Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2018-02-27 | Injury | None | High impedance, Ambient Noise Problem |
| 2018-02-26 | Injury | None | Defective Device |
| 2018-02-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-02-23 | Malfunction | None | High impedance, Ambient Noise Problem |
| 2018-02-22 | Injury | None | High impedance |
| 2018-02-22 | Injury | None | Pacing Problem |
| 2018-02-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-02-22 | Injury | None | Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2018-02-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-02-19 | Malfunction | None | Premature Discharge of Battery |
| 2018-02-19 | Malfunction | None | High impedance |
| 2018-02-16 | Injury | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2018-02-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-02-15 | Injury | None | Failure to Capture |
| 2018-02-13 | Injury | None | Premature Discharge of Battery |
| 2018-02-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-02-10 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2018-02-08 | Injury | None | Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2018-02-08 | Injury | None | Over-Sensing |
| 2018-02-08 | Injury | None | Failure to Capture, Over-Sensing, Pacing Problem, Pocket Stimulation, Ambient Noise Problem |
| 2018-02-07 | Malfunction | None | Failure to Capture |
| 2018-02-02 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2018-02-01 | Malfunction | None | High impedance |
| 2018-02-01 | Injury | None | High impedance, Over-Sensing, Pocket Stimulation, Ambient Noise Problem, Capturing Problem |
| 2018-01-31 | Malfunction | None | High impedance, Ambient Noise Problem |
| 2018-01-30 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-01-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-22 | Injury | None | Migration or Expulsion of Device |
| 2018-01-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-17 | Malfunction | None | Over-Sensing, Impedance Problem |
| 2018-01-17 | Injury | None | Premature Discharge of Battery |
| 2018-01-16 | Injury | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2018-01-15 | Injury | None | Failure to Capture, Over-Sensing, Ambient Noise Problem, Battery Problem, Device Sensing Problem, Impedance Problem |
| 2018-01-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-12 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2018-01-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-08 | Malfunction | None | Pacing Problem |
| 2018-01-06 | Malfunction | None | Over-Sensing, Under-Sensing, Low impedance, Ambient Noise Problem |
| 2018-01-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-04 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-01-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-01 | Injury | None | Defective Device, Communication or Transmission Problem |
| 2018-01-01 | Malfunction | None | Failure to Capture, High impedance, Under-Sensing |
| 2018-01-01 | Malfunction | None | High impedance |
| 2018-01-01 | Malfunction | None | High impedance, Over-Sensing, Pacing Problem, Device Sensing Problem |
| 2017-12-29 | Injury | None | Device Operates Differently Than Expected |
| 2017-12-28 | Injury | None | Failure to Capture, Over-Sensing, Pacing Problem, Ambient Noise Problem, Capturing Problem |
| 2017-12-28 | Injury | None | Failure to Capture, Capturing Problem |
| 2017-12-28 | Malfunction | None | Failure to Capture, Communication or Transmission Problem |
| 2017-12-28 | Malfunction | None | Failure to Capture, Over-Sensing |
| 2017-12-27 | Injury | None | Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2017-12-27 | Malfunction | None | Device Displays Incorrect Message |
| 2017-12-21 | Malfunction | None | High impedance, Ambient Noise Problem |
| 2017-12-19 | Injury | None | High impedance, Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2017-12-19 | Malfunction | None | Device Displays Incorrect Message, Device Operates Differently Than Expected |
| 2017-12-19 | Injury | None | Device Operates Differently Than Expected |
| 2017-12-16 | Malfunction | None | High impedance |
| 2017-12-11 | Injury | None | High impedance, Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2017-12-10 | Malfunction | None | High impedance, Ambient Noise Problem |
| 2017-12-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-12-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-12-05 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2017-12-02 | Malfunction | None | Over-Sensing, Ambient Noise Problem |
| 2017-12-01 | Malfunction | None | High impedance, Over-Sensing, Pocket Stimulation, Ambient Noise Problem |
| 2017-12-01 | Malfunction | None | Low impedance |
| 2017-11-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-11-23 | Malfunction | Bradycardia | Signal Artifact/Noise, Failure to Capture, Over-Sensing, Pacing Problem, Failure to Read Input Signal, Impedance Problem |
| 2017-11-22 | Malfunction | None | Electrical /Electronic Property Problem, High impedance, Over-Sensing, Ambient Noise Problem |
| 2017-11-21 | Injury | None | Device Operates Differently Than Expected |
| 2017-11-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-11-17 | Injury | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2017-11-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-11-13 | Malfunction | None | Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2017-11-08 | Injury | None | Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2017-11-08 | Malfunction | None | Over-Sensing, Connection Problem, Impedance Problem |
| 2017-11-03 | Malfunction | None | High impedance, Ambient Noise Problem |
| 2017-11-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-11-02 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2017-11-02 | Malfunction | None | Signal Artifact/Noise, High impedance, Over-Sensing, Ambient Noise Problem |
| 2017-11-01 | Injury | None | Failure to Capture, High impedance |
| 2017-11-01 | Malfunction | None | High impedance, Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2017-10-31 | Injury | None | Signal Artifact/Noise, High impedance, Over-Sensing, High Capture Threshold |
| 2017-10-30 | Malfunction | None | High impedance |
| 2017-10-26 | Malfunction | None | High impedance |
| 2017-10-25 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-10-24 | Injury | None | Over-Sensing, Pacing Problem, Ambient Noise Problem, Device Sensing Problem |
| 2017-10-23 | Injury | None | Over-Sensing, Pacing Problem, Ambient Noise Problem, Capturing Problem, Adverse Event Without Identified Device or Use Problem |
| 2017-10-18 | Malfunction | None | Over-Sensing, Ambient Noise Problem |
| 2017-10-17 | Injury | None | Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2017-10-16 | Malfunction | None | High impedance |
| 2017-10-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-11 | Malfunction | None | High impedance, Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2017-10-10 | Malfunction | None | Signal Artifact/Noise, High impedance, Over-Sensing, Ambient Noise Problem |
| 2017-10-10 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2017-10-09 | Injury | None | High impedance |
| 2017-10-08 | Malfunction | None | Premature Discharge of Battery |
| 2017-10-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-05 | Malfunction | None | Over-Sensing, Ambient Noise Problem |
| 2017-10-04 | Injury | None | Failure to Capture, Capturing Problem |
| 2017-10-03 | Injury | None | Impedance Problem |
| 2017-10-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-01 | Injury | None | Signal Artifact/Noise, High impedance, Over-Sensing, Pacing Problem, Under-Sensing, Device Sensing Problem |
| 2017-09-29 | Malfunction | None | Electrical /Electronic Property Problem, Over-Sensing, Ambient Noise Problem |
| 2017-09-27 | Malfunction | None | High impedance |
| 2017-09-27 | Injury | None | High impedance |
| 2017-09-26 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem, Device Operates Differently Than Expected, Impedance Problem |
| 2017-09-26 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-09-22 | Injury | None | Over-Sensing, Pacing Problem, Communication or Transmission Problem, Device Operates Differently Than Expected |
| 2017-09-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-09-21 | Injury | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2017-09-20 | Injury | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2017-09-20 | Injury | None | Pacing Problem |
| 2017-09-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-09-17 | Injury | None | Premature Discharge of Battery |
| 2017-09-15 | Malfunction | None | High impedance, Pacing Problem, Material Integrity Problem |
| 2017-09-14 | Malfunction | None | Failure to Capture |
| 2017-09-12 | Malfunction | None | Over-Sensing, Ambient Noise Problem, Impedance Problem |
| 2017-09-12 | Malfunction | None | Electrical /Electronic Property Problem, High impedance, Over-Sensing, Ambient Noise Problem |
| 2017-09-11 | Malfunction | None | High impedance, Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2017-09-11 | Injury | None | Device Operates Differently Than Expected |
| 2017-09-07 | Injury | None | High impedance |
| 2017-09-07 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem, Capturing Problem |
| 2017-09-06 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2017-09-05 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-09-05 | Injury | None | Over-Sensing, Pacing Problem |
| 2017-09-05 | Injury | None | High impedance |
| 2017-09-05 | Malfunction | None | Failure to Capture, High impedance, Pocket Stimulation |
| 2017-09-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-09-01 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2017-09-01 | Injury | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2017-09-01 | Malfunction | None | High impedance |
| 2017-08-31 | Malfunction | None | Device Displays Incorrect Message, Device Operates Differently Than Expected |
| 2017-08-29 | Injury | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2017-08-26 | Injury | None | Device Displays Incorrect Message, Device Operates Differently Than Expected |
| 2017-08-21 | Injury | None | Over-Sensing, Pacing Problem |
| 2017-08-14 | Malfunction | None | High impedance, Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2017-08-11 | Injury | None | Over-Sensing |
| 2017-08-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-08-06 | Malfunction | None | Failure to Capture, High impedance, High Capture Threshold |
| 2017-08-03 | Injury | None | Device Operates Differently Than Expected |
| 2017-08-03 | Injury | None | Signal Artifact/Noise, Over-Sensing, Pacing Problem, Ambient Noise Problem, Impedance Problem |
| 2017-08-02 | Injury | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2017-08-01 | Injury | None | Failure to Capture, High impedance, Device Sensing Problem |
| 2017-08-01 | Malfunction | None | Over-Sensing, Low impedance, Ambient Noise Problem, Device Sensing Problem |
| 2017-08-01 | Injury | None | High impedance, Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2017-07-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-07-30 | Injury | None | Electrical /Electronic Property Problem, Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2017-07-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-07-28 | Injury | None | Ambient Noise Problem |
| 2017-07-27 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2017-07-25 | Injury | None | Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2017-07-21 | Injury | None | High impedance, Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2017-07-21 | Malfunction | None | High impedance |
| 2017-07-21 | Injury | None | Failure to Capture, Impedance Problem |
| 2017-07-17 | Malfunction | None | High impedance, Over-Sensing, Pocket Stimulation, Ambient Noise Problem |
| 2017-07-14 | Injury | None | Device Operates Differently Than Expected |
| 2017-07-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-07-13 | Injury | None | Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2017-07-12 | Malfunction | None | Device Displays Incorrect Message |
| 2017-07-12 | Malfunction | None | Failure to Capture, Use of Device Problem, Fitting Problem |
| 2017-07-12 | Injury | None | Failure to Capture, High impedance, Over-Sensing, Ambient Noise Problem, Connection Problem |
| 2017-07-11 | Injury | None | Failure to Capture, High impedance, Pacing Problem, Capturing Problem |
| 2017-07-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-07-10 | Injury | None | Failure to Capture, Pacing Problem |
| 2017-07-10 | Injury | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2017-07-07 | Malfunction | None | Ambient Noise Problem, Device Operates Differently Than Expected |
| 2017-07-06 | Injury | None | High impedance, Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2017-07-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-07-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-07-02 | Injury | None | Failure to Capture |
| 2017-07-01 | Malfunction | None | Failure to Capture, High impedance |
| 2017-07-01 | Injury | None | Electrical /Electronic Property Problem, High impedance, Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2017-07-01 | Malfunction | None | High impedance |
| 2017-06-30 | Injury | None | Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2017-06-29 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-06-26 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2017-06-24 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2017-06-23 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-06-22 | Malfunction | None | Use of Device Problem |
| 2017-06-20 | Malfunction | None | Failure to Capture, Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2017-06-19 | Injury | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2017-06-12 | Malfunction | None | Pacing Problem, Ambient Noise Problem |
| 2017-06-12 | Malfunction | None | Device Displays Incorrect Message |
| 2017-06-11 | Malfunction | None | Failure to Capture, Pacing Problem |
| 2017-06-10 | Malfunction | None | High impedance, Over-Sensing, Device Sensing Problem |
| 2017-06-10 | Malfunction | None | High impedance |
| 2017-06-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-06-06 | Malfunction | None | High impedance, Ambient Noise Problem |
| 2017-06-06 | Injury | None | Failure to Capture, Use of Device Problem, Device Operates Differently Than Expected |
| 2017-06-05 | Injury | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2017-06-04 | Malfunction | None | Failure to Capture, High impedance, Over-Sensing, Failure to Sense, Defective Device, Device Sensing Problem |
| 2017-06-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-05-31 | Malfunction | None | Premature Discharge of Battery |
| 2017-05-30 | Injury | No Clinical Signs, Symptoms or Conditions | Signal Artifact/Noise, Over-Sensing |
| 2017-05-30 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-05-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-05-26 | Injury | None | Failure to Capture, Migration or Expulsion of Device, Pocket Stimulation |
| 2017-05-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-05-26 | Injury | None | Electrical /Electronic Property Problem, Over-Sensing, Pacing Problem, Low impedance, Ambient Noise Problem, Device Sensing Problem |
| 2017-05-25 | Malfunction | None | High impedance, Ambient Noise Problem |
| 2017-05-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-05-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-05-19 | Malfunction | None | High impedance, Over-Sensing, Device Operates Differently Than Expected |
| 2017-05-17 | Malfunction | None | High impedance, Pacing Problem, Ambient Noise Problem |
| 2017-05-17 | Malfunction | None | Failure to Capture, High impedance |
| 2017-05-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-05-16 | Malfunction | None | High impedance, Pacing Problem, Ambient Noise Problem |
| 2017-05-16 | Injury | None | Failure to Capture, Capturing Problem |
| 2017-05-16 | Injury | None | Premature Discharge of Battery |
| 2017-05-15 | Injury | None | Pacing Problem, Ambient Noise Problem |
| 2017-05-10 | Malfunction | None | High impedance, Over-Sensing, Pocket Stimulation, Low impedance, Ambient Noise Problem, Capturing Problem, Device Sensing Problem, High Capture Threshold |
| 2017-05-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-05-09 | Malfunction | None | High impedance |
| 2017-05-05 | Injury | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2017-05-05 | Malfunction | None | High impedance |
| 2017-05-03 | Injury | None | Premature Discharge of Battery |
| 2017-05-01 | Injury | None | Over-Sensing, Pacing Problem, Low impedance |
| 2017-05-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-04-26 | Injury | None | Migration or Expulsion of Device |
| 2017-04-25 | Malfunction | None | Premature Discharge of Battery |
| 2017-04-24 | Injury | None | High impedance |
| 2017-04-22 | Malfunction | None | Ambient Noise Problem, Impedance Problem |
| 2017-04-21 | Injury | None | Device Displays Incorrect Message, Device Operates Differently Than Expected |
| 2017-04-20 | Malfunction | None | Electrical /Electronic Property Problem |
| 2017-04-13 | Malfunction | None | Low impedance, Ambient Noise Problem |
| 2017-04-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-04-10 | Malfunction | None | High impedance |
| 2017-04-07 | Malfunction | None | Electrical /Electronic Property Problem, Over-Sensing, Low impedance, Ambient Noise Problem |
| 2017-04-07 | Injury | None | Failure to Capture, Ambient Noise Problem, Capturing Problem |
| 2017-04-06 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-04-04 | Malfunction | None | High impedance |
| 2017-04-01 | Injury | None | Failure to Capture, High impedance, Over-Sensing, Ambient Noise Problem |
| 2017-04-01 | Malfunction | None | High impedance, Ambient Noise Problem, Device Operates Differently Than Expected |
| 2017-04-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-04-01 | Malfunction | None | Over-Sensing |
| 2017-03-31 | Malfunction | None | Over-Sensing |
| 2017-03-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-24 | Injury | None | Device Operates Differently Than Expected |
| 2017-03-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-20 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-03-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-17 | Injury | None | Failure to Capture |
| 2017-03-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-16 | Injury | None | High impedance, Ambient Noise Problem |
| 2017-03-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-15 | Injury | None | Failure to Capture, High impedance, Pacing Problem, Under-Sensing |
| 2017-03-12 | Injury | None | High impedance |
| 2017-03-12 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-11 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2017-03-09 | Malfunction | None | Fitting Problem |
| 2017-03-07 | Injury | None | Premature Discharge of Battery, Communication or Transmission Problem, Device Operates Differently Than Expected, Material Integrity Problem |
| 2017-03-06 | Malfunction | None | Low impedance, Device Operates Differently Than Expected |
| 2017-03-03 | Malfunction | None | Fitting Problem |
| 2017-03-03 | Injury | None | Pacing Problem |
| 2017-03-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-01 | Injury | None | Failure to Capture, Over-Sensing, Ambient Noise Problem |
| 2017-03-01 | Injury | None | Migration or Expulsion of Device |
| 2017-02-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-02-23 | Injury | None | Failure to Capture, Over-Sensing, Low impedance, Ambient Noise Problem |
| 2017-02-23 | Injury | None | Failure to Capture |
| 2017-02-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-02-18 | Injury | None | Over-Sensing, Pacing Problem, Ambient Noise Problem, Device Sensing Problem |
| 2017-02-16 | Malfunction | None | Fitting Problem |
| 2017-02-16 | Injury | None | Electrical /Electronic Property Problem, Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2017-02-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-02-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-02-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-02-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-02-10 | Injury | None | Premature Discharge of Battery, High impedance, Over-Sensing, Ambient Noise Problem, Communication or Transmission Problem |
| 2017-02-10 | Injury | None | Failure to Capture, High impedance, Capturing Problem |
| 2017-02-04 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-02-03 | Malfunction | None | Over-Sensing, Ambient Noise Problem |
| 2017-02-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-02-02 | Malfunction | None | High impedance |
| 2017-02-01 | Malfunction | None | High impedance, Over-Sensing, Pacing Problem, Pocket Stimulation, Ambient Noise Problem |
| 2017-02-01 | Malfunction | None | Failure to Capture, Pacing Problem, Communication or Transmission Problem |
| 2017-02-01 | Malfunction | None | High impedance, Ambient Noise Problem |
| 2017-01-31 | Injury | None | High impedance, Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2017-01-30 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-30 | Malfunction | None | High impedance |
| 2017-01-27 | Malfunction | None | Fitting Problem |
| 2017-01-27 | Malfunction | None | High impedance |
| 2017-01-26 | Injury | None | Premature Discharge of Battery, Low impedance |
| 2017-01-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-21 | Injury | None | Pacing Problem, Device Operates Differently Than Expected |
| 2017-01-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-20 | Malfunction | None | Pacing Problem, Device Operates Differently Than Expected |
| 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 | Malfunction | None | Premature Discharge of Battery, Over-Sensing, Ambient Noise Problem, Device Operates Differently Than Expected |
| 2017-01-16 | Malfunction | None | Over-Sensing, Device Sensing Problem |
| 2017-01-11 | Malfunction | None | Fitting Problem |
| 2017-01-11 | Injury | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2017-01-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-04 | Injury | None | Over-Sensing |
| 2017-01-03 | Malfunction | None | Over-Sensing, Ambient Noise Problem |
| 2017-01-01 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2017-01-01 | Malfunction | None | High impedance, Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2017-01-01 | Malfunction | None | Over-Sensing, Pacing Problem, Low impedance, Ambient Noise Problem |
| 2016-12-30 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-12-30 | Injury | None | Device Operates Differently Than Expected |
| 2016-12-28 | Malfunction | None | Low impedance |
| 2016-12-22 | Malfunction | None | Device Displays Incorrect Message |
| 2016-12-22 | Malfunction | None | High impedance, Device Displays Incorrect Message |
| 2016-12-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-12-16 | Injury | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2016-12-15 | Injury | None | Failure to Capture, Capturing Problem |
| 2016-12-14 | Injury | None | Premature Discharge of Battery |
| 2016-12-12 | Malfunction | None | Signal Artifact/Noise, High impedance, Over-Sensing, Failure to Read Input Signal |
| 2016-12-10 | Injury | None | Premature Discharge of Battery, Device Displays Incorrect Message |
| 2016-12-06 | Injury | None | High impedance, Over-Sensing, Pacing Problem, Capturing Problem |
| 2016-12-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-12-02 | Injury | None | Migration or Expulsion of Device, Adverse Event Without Identified Device or Use Problem |
| 2016-12-02 | Malfunction | None | Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2016-12-01 | Malfunction | None | Over-Sensing, Pacing Problem, Ambient Noise Problem, Capturing Problem |
| 2016-12-01 | Injury | None | Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2016-11-29 | Injury | None | Premature Discharge of Battery |
| 2016-11-28 | Injury | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2016-11-26 | Malfunction | None | Low impedance, Ambient Noise Problem, Device Sensing Problem |
| 2016-11-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-11-22 | Malfunction | None | High impedance, Capturing Problem |
| 2016-11-22 | Injury | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2016-11-22 | 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 | Malfunction | None | Premature Discharge of Battery, Over-Sensing, Ambient Noise Problem |
| 2016-11-11 | Injury | None | Over-Sensing, Capturing Problem |
| 2016-11-11 | Malfunction | None | High impedance |
| 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 |
| 2016-11-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-11-02 | Death | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2016-11-01 | Injury | None | Device Operates Differently Than Expected |
| 2016-11-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-11-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-11-01 | Injury | None | Over-Sensing, Pacing Problem, Ambient Noise Problem, Impedance Problem |
| 2016-10-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-10-31 | Malfunction | None | High impedance, Ambient Noise Problem |
| 2016-10-30 | Injury | None | Device Operates Differently Than Expected |
| 2016-10-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-10-27 | Injury | None | Low impedance, Capturing Problem, Device Operates Differently Than Expected |
| 2016-10-25 | Injury | None | Premature Discharge of Battery |
| 2016-10-24 | Injury | None | Device Operates Differently Than Expected |
| 2016-10-24 | Injury | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2016-10-20 | Malfunction | None | High impedance |
| 2016-10-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-10-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-10-17 | Malfunction | Insufficient Information | Signal Artifact/Noise, High impedance, Over-Sensing, Defective Device, Ambient Noise Problem, Device Sensing Problem |
| 2016-10-14 | Malfunction | None | High impedance |
| 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 |
| 2016-10-07 | Malfunction | None | Over-Sensing, Ambient Noise Problem, Device Sensing Problem |
| 2016-09-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-09-29 | Malfunction | None | Low impedance |
| 2016-09-28 | Injury | None | Failure to Capture, High impedance |
| 2016-09-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-09-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-09-23 | Injury | None | Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2016-09-22 | Malfunction | None | Connection Problem |
| 2016-09-22 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-09-21 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-09-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-09-19 | Injury | None | Device Operates Differently Than Expected |
| 2016-09-14 | Malfunction | None | Failure to Capture, Failure to Sense, Low impedance, Capturing Problem, High Capture Threshold |
| 2016-09-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-09-13 | Malfunction | None | Device Displays Incorrect Message |
| 2016-09-12 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-09-12 | Injury | None | Premature Discharge of Battery |
| 2016-09-08 | Malfunction | None | Over-Sensing, Ambient Noise Problem, Impedance Problem |
| 2016-09-08 | Malfunction | None | High impedance |
| 2016-09-06 | Injury | None | High impedance, Capturing Problem, Device Sensing Problem |
| 2016-09-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-09-01 | Injury | None | Device Operates Differently Than Expected |
| 2016-09-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-09-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-08-29 | Injury | None | Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2016-08-26 | Malfunction | None | Over-Sensing, Pacing Problem, Device Operates Differently Than Expected |
| 2016-08-25 | Malfunction | None | High impedance |
| 2016-08-25 | Injury | None | Over-Sensing, Ambient Noise Problem |
| 2016-08-23 | Malfunction | None | Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2016-08-19 | Malfunction | None | Ambient Noise Problem |
| 2016-08-18 | Injury | None | High impedance, Low impedance, Ambient Noise Problem |
| 2016-08-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-08-17 | Injury | None | Failure to Capture, Connection Problem |
| 2016-08-17 | Malfunction | None | Over-Sensing, Ambient Noise Problem, Device Operates Differently Than Expected, Impedance Problem |
| 2016-08-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-08-15 | Injury | None | Device Operates Differently Than Expected |
| 2016-08-15 | Malfunction | None | Over-Sensing, Pacing Problem, Device Operates Differently Than Expected |
| 2016-08-12 | Malfunction | None | Over-Sensing, Pacing Problem, Ambient Noise Problem, Capturing Problem |
| 2016-08-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-08-04 | Injury | None | Over-Sensing, Pacing Problem |
| 2016-08-04 | Malfunction | None | High impedance |
| 2016-08-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-08-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-08-02 | Malfunction | None | High impedance |
| 2016-08-01 | Injury | None | Device Operates Differently Than Expected |
| 2016-07-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-07-26 | Injury | None | Over-Sensing, Pocket Stimulation, Low impedance, Ambient Noise Problem |
| 2016-07-23 | Malfunction | None | High impedance |
| 2016-07-21 | Injury | None | Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2016-07-20 | Malfunction | None | Device Displays Incorrect Message |
| 2016-07-17 | Injury | None | Failure to Capture, Pacing Problem, Communication or Transmission Problem |
| 2016-07-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-07-15 | Injury | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2016-07-12 | Malfunction | None | Communication or Transmission Problem, Interrogation Problem |
| 2016-07-06 | Injury | None | Failure to Capture, High impedance, Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2016-07-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-07-06 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-07-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-07-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-07-01 | Malfunction | None | High impedance |
| 2016-06-29 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2016-06-29 | Injury | None | Premature Discharge of Battery, Device Operates Differently Than Expected |
| 2016-06-27 | Injury | None | No Audible Alarm, Premature Discharge of Battery, Pacing Problem, Device Displays Incorrect Message, Communication or Transmission Problem |
| 2016-06-25 | Malfunction | None | Premature Discharge of Battery |
| 2016-06-22 | Injury | None | Failure to Capture, High impedance, Pacing Problem |
| 2016-06-21 | Malfunction | None | Device Displays Incorrect Message |
| 2016-06-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-06-16 | Injury | None | Device Operates Differently Than Expected |
| 2016-06-14 | Injury | None | Device Operates Differently Than Expected |
| 2016-06-08 | Malfunction | None | Over-Sensing, Low impedance, Ambient Noise Problem |
| 2016-06-06 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-06-06 | Malfunction | None | Impedance Problem |
| 2016-06-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-06-03 | Injury | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2016-06-01 | Injury | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2016-06-01 | Malfunction | None | Electrical /Electronic Property Problem, High impedance, Over-Sensing, Ambient Noise Problem |
| 2016-05-31 | Injury | None | Device Operates Differently Than Expected |
| 2016-05-29 | Malfunction | None | High impedance |
| 2016-05-24 | Injury | None | High impedance, Capturing Problem, Connection Problem |
| 2016-05-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-05-17 | Malfunction | None | Premature Discharge of Battery |
| 2016-05-15 | Malfunction | None | Electrical /Electronic Property Problem |
| 2016-05-05 | Malfunction | None | High impedance |
| 2016-04-29 | Injury | None | Device Operates Differently Than Expected |
| 2016-04-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-04-16 | Malfunction | None | Over-Sensing, Pacing Problem, Ambient Noise Problem, Capturing Problem |
| 2016-04-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-04-11 | Malfunction | None | High impedance, Ambient Noise Problem |
| 2016-04-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-03-21 | Malfunction | None | Adverse Event Without Identified Device or Use Problem |
| 2016-03-18 | Malfunction | None | Over-Sensing, Ambient Noise Problem |
| 2016-03-07 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2016-01-21 | Malfunction | None | Device Displays Incorrect Message |
| 2016-01-01 | Injury | None | Pocket Stimulation, Migration |
| 2016-01-01 | Injury | None | Premature Discharge of Battery |
| 2015-11-15 | Injury | None | Over-Sensing, Ambient Noise Problem |
| 2015-08-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2015-07-18 | Injury | None | Premature Discharge of Battery |
| 2015-01-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 1995-09-11 | Malfunction | None | Low impedance |