IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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 |
|---|---|---|---|
| 2024-07-17 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2024-07-16 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2024-07-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-07-10 | Injury | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings, Battery Problem, Interrogation Problem |
| 2024-06-26 | Malfunction | Syncope/Fainting | Under-Sensing |
| 2024-06-19 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2024-06-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | Over-Sensing |
| 2024-05-28 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery, Interrogation Problem |
| 2024-05-28 | Injury | Pocket Erosion | Adverse Event Without Identified Device or Use Problem |
| 2024-05-21 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery, Battery Problem |
| 2024-05-13 | Death | Syncope/Fainting | Incorrect, Inadequate or Imprecise Result or Readings, Telemetry Discrepancy, Battery Problem, Inappropriate or Unexpected Reset, Interrogation Problem |
| 2024-05-13 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2024-05-06 | Injury | Device Overstimulation of Tissue | Pacing Problem, Incorrect, Inadequate or Imprecise Result or Readings |
| 2024-05-04 | Injury | Bradycardia | Failure to Capture, Pacing Problem, High Capture Threshold |
| 2024-05-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-04-29 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2024-04-28 | Injury | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings |
| 2024-04-20 | Injury | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings |
| 2024-04-18 | Injury | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings |
| 2024-04-18 | Injury | No Clinical Signs, Symptoms or Conditions | Signal Artifact/Noise, Over-Sensing, Low impedance, Battery Problem, High Capture Threshold |
| 2024-04-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings |
| 2024-04-17 | Injury | No Clinical Signs, Symptoms or Conditions | Failure to Capture, Failure to Sense, Connection Problem |
| 2024-04-15 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2024-04-05 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2024-04-05 | Injury | Fall, Syncope/Fainting | Failure to Capture, Failure to Read Input Signal, High Capture Threshold |
| 2024-04-05 | Injury | No Clinical Signs, Symptoms or Conditions | Signal Artifact/Noise, Failure to Capture, High impedance, Over-Sensing, Pacing Problem |
| 2024-04-03 | Injury | Unspecified Infection, Pocket Erosion | Adverse Event Without Identified Device or Use Problem |
| 2024-04-03 | Injury | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings |
| 2024-04-02 | Malfunction | No Clinical Signs, Symptoms or Conditions | Over-Sensing |
| 2024-04-02 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture, Over-Sensing, Under-Sensing |
| 2024-03-29 | Injury | Bacterial Infection, Sepsis | Adverse Event Without Identified Device or Use Problem |
| 2024-03-28 | Malfunction | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2024-03-27 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery, Battery Problem |
| 2024-03-26 | Injury | No Clinical Signs, Symptoms or Conditions | Battery Problem, Interrogation Problem |
| 2024-03-25 | Malfunction | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery, Battery Problem |
| 2024-03-25 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2024-03-25 | Injury | Syncope/Fainting | None |
| 2024-03-23 | Malfunction | No Clinical Signs, Symptoms or Conditions | Under-Sensing |
| 2024-03-20 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-12 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Signal Artifact/Noise, High impedance, Over-Sensing |
| 2024-03-05 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-04 | Injury | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings |
| 2024-02-29 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2024-02-29 | Malfunction | Bradycardia | None |
| 2024-02-28 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2024-02-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture |
| 2024-02-16 | Injury | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings |
| 2024-02-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery, Battery Problem |
| 2024-02-12 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2024-02-12 | Injury | Unspecified Infection, Pocket Erosion | Adverse Event Without Identified Device or Use Problem |
| 2024-02-07 | Injury | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings |
| 2024-02-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Over-Sensing, Failure to Read Input Signal |
| 2024-01-29 | Injury | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings |
| 2024-01-24 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2024-01-24 | Injury | Bradycardia, Dizziness, Presyncope | Signal Artifact/Noise, Over-Sensing, Pacing Problem, Incorrect, Inadequate or Imprecise Result or Readings |
| 2024-01-19 | Injury | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem, Interrogation Problem |
| 2024-01-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings |
| 2024-01-12 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2024-01-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery, Incorrect, Inadequate or Imprecise Result or Readings |
| 2024-01-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2023-12-23 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture, Under-Sensing, Device Sensing Problem, High Capture Threshold |
| 2023-12-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | Defective Device |
| 2023-12-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2023-12-15 | Malfunction | Asystole | Signal Artifact/Noise, Over-Sensing, Pacing Problem |
| 2023-12-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Over-Sensing, Failure to Read Input Signal, Under-Sensing |
| 2023-12-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2023-11-03 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-10-30 | Injury | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings |
| 2023-10-24 | Malfunction | No Clinical Signs, Symptoms or Conditions | Pacing Problem, Under-Sensing, Use of Device Problem |
| 2023-10-24 | Injury | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings |
| 2023-10-23 | Injury | Unspecified Infection, Pocket Erosion | Off-Label Use, Adverse Event Without Identified Device or Use Problem |
| 2023-10-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | Over-Sensing, Defective Device |
| 2023-10-17 | Injury | Erosion, Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-10-16 | Malfunction | Bradycardia | Failure to Capture, High Capture Threshold |
| 2023-10-10 | Injury | Twitching, Presyncope, Asystole | Failure to Capture, Incorrect, Inadequate or Imprecise Result or Readings, Battery Problem |
| 2023-10-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2023-10-03 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery, Battery Problem |
| 2023-09-28 | Injury | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings |
| 2023-09-28 | Malfunction | No Clinical Signs, Symptoms or Conditions | Defective Device |
| 2023-09-20 | Injury | Asystole | Failure to Capture, Incorrect, Inadequate or Imprecise Result or Readings |
| 2023-09-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance, Telemetry Discrepancy |
| 2023-09-11 | Malfunction | Dizziness | Failure to Capture, Over-Sensing, Pacing Problem |
| 2023-09-08 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-09-08 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-09-05 | Injury | Unspecified Infection, Pocket Erosion | Adverse Event Without Identified Device or Use Problem |
| 2023-08-30 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery, Battery Problem |
| 2023-08-30 | Injury | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings |
| 2023-08-25 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-08-18 | Injury | Syncope/Fainting | Defective Device |
| 2023-08-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | Under-Sensing |
| 2023-08-17 | Injury | Syncope/Fainting | Pacing Problem |
| 2023-08-09 | Malfunction | Asystole | Signal Artifact/Noise, Over-Sensing, Pacing Problem |
| 2023-08-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | Signal Artifact/Noise, Over-Sensing, Pacing Problem |
| 2023-08-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | Signal Artifact/Noise, Over-Sensing, Impedance Problem |
| 2023-08-03 | Injury | Syncope/Fainting, Asystole | Premature Discharge of Battery, Pacing Problem, Incorrect, Inadequate or Imprecise Result or Readings |
| 2023-08-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2023-07-24 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2023-07-17 | Injury | No Clinical Signs, Symptoms or Conditions | Defective Device |
| 2023-07-16 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2023-07-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | Defective Device |
| 2023-07-13 | Malfunction | No Clinical Signs, Symptoms or Conditions | False Positive Result |
| 2023-07-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Under-Sensing |
| 2023-07-09 | Injury | Presyncope | Failure to Capture, High impedance, Pacing Problem, High Capture Threshold |
| 2023-07-07 | Injury | No Clinical Signs, Symptoms or Conditions | High Capture Threshold |
| 2023-07-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture, Pacing Problem |
| 2023-07-04 | Injury | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings |
| 2023-07-03 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery, Battery Problem |
| 2023-06-30 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance |
| 2023-06-23 | Malfunction | No Clinical Signs, Symptoms or Conditions | Over-Sensing |
| 2023-06-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | False Positive Result, Over-Sensing |
| 2023-06-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2023-06-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Defective Device |
| 2023-06-08 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery, Battery Problem |
| 2023-06-07 | Malfunction | No Clinical Signs, Symptoms or Conditions | Signal Artifact/Noise, Over-Sensing |
| 2023-05-31 | Malfunction | No Clinical Signs, Symptoms or Conditions | Telemetry Discrepancy |
| 2023-05-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | Signal Artifact/Noise, Over-Sensing |
| 2023-05-18 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-05-10 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery, Incorrect, Inadequate or Imprecise Result or Readings |
| 2023-05-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | Signal Artifact/Noise, High impedance, Over-Sensing, Connection Problem |
| 2023-05-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | Under-Sensing |
| 2023-05-05 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-05-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2023-04-24 | Injury | Syncope/Fainting | Incorrect, Inadequate or Imprecise Result or Readings |
| 2023-04-15 | Injury | Tachycardia | Pacing Problem, Inaccurate Synchronization, Under-Sensing |
| 2023-04-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings |
| 2023-04-01 | Injury | Sepsis | Failure to Capture, Pacing Problem, Failure to Read Input Signal |
| 2023-03-30 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture |
| 2023-03-23 | Injury | Loss of consciousness, Syncope/Fainting, Asystole | Signal Artifact/Noise, Over-Sensing, Pacing Problem, Incorrect, Inadequate or Imprecise Result or Readings |
| 2023-03-23 | Injury | Unspecified Infection, Sepsis | Adverse Event Without Identified Device or Use Problem |
| 2023-03-16 | Injury | No Clinical Signs, Symptoms or Conditions | Signal Artifact/Noise, Premature Discharge of Battery, High impedance, Battery Problem |
| 2023-02-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | Under-Sensing |
| 2023-02-13 | Injury | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2023-02-06 | Injury | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings |
| 2023-02-01 | Injury | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings |
| 2023-01-25 | Malfunction | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2023-01-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery, Incorrect, Inadequate or Imprecise Result or Readings |
| 2023-01-15 | Injury | Syncope/Fainting | Pacing Problem, Incorrect, Inadequate or Imprecise Result or Readings |
| 2023-01-14 | Malfunction | Appropriate Term / Code Not Available, No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2023-01-11 | Injury | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings |
| 2023-01-09 | Injury | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings |
| 2022-12-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2022-12-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance |
| 2022-12-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-12-09 | Malfunction | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2022-12-03 | Injury | No Clinical Signs, Symptoms or Conditions | Incorrect, Inadequate or Imprecise Result or Readings |
| 2022-12-02 | Malfunction | No Clinical Signs, Symptoms or Conditions | Premature Discharge of Battery |
| 2022-11-29 | Injury | None | High impedance |
| 2022-11-19 | Injury | None | Premature Discharge of Battery, Pocket Stimulation, Incorrect, Inadequate or Imprecise Result or Readings |
| 2022-11-17 | Injury | None | Premature Discharge of Battery |
| 2022-11-14 | Injury | None | Premature Discharge of Battery |
| 2022-11-10 | Malfunction | None | Failure to Capture, Pacing Problem |
| 2022-11-10 | Injury | None | Incorrect, Inadequate or Imprecise Result or Readings, Defective Device |
| 2022-11-08 | Malfunction | None | Premature Discharge of Battery |
| 2022-11-03 | Malfunction | None | Premature Discharge of Battery, Battery Problem |
| 2022-11-02 | Malfunction | None | Defective Device |
| 2022-10-31 | Malfunction | No Clinical Signs, Symptoms or Conditions | Over-Sensing |
| 2022-10-26 | Injury | None | Premature Discharge of Battery |
| 2022-10-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-10-21 | Injury | None | Incorrect, Inadequate or Imprecise Result or Readings |
| 2022-10-13 | Injury | None | Failure to Capture, High impedance, Connection Problem |
| 2022-10-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | Defective Device |
| 2022-10-07 | Malfunction | None | High impedance |
| 2022-10-07 | Malfunction | None | Defective Device |
| 2022-09-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-09-14 | Malfunction | None | Premature Discharge of Battery |
| 2022-09-06 | Injury | None | Premature Discharge of Battery |
| 2022-09-01 | Malfunction | None | Premature Discharge of Battery, Battery Problem |
| 2022-08-17 | Injury | None | Premature Discharge of Battery |
| 2022-08-10 | Malfunction | None | Defective Device |
| 2022-08-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-08-02 | Injury | None | Premature Discharge of Battery, Battery Problem |
| 2022-07-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-07-01 | Injury | None | Defective Device |
| 2022-05-25 | Malfunction | None | Signal Artifact/Noise, High impedance |
| 2022-04-28 | Malfunction | No Clinical Signs, Symptoms or Conditions | Signal Artifact/Noise, High impedance, Over-Sensing |
| 2022-04-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Over-Sensing |
| 2022-03-29 | Injury | None | Premature Discharge of Battery, Battery Problem |
| 2022-03-27 | Injury | None | Incorrect, Inadequate or Imprecise Result or Readings |
| 2022-03-24 | Injury | None | Premature Discharge of Battery, Battery Problem |
| 2022-03-16 | Malfunction | None | Signal Artifact/Noise, Over-Sensing, Low impedance |
| 2022-03-16 | Malfunction | None | Failure to Capture, High Capture Threshold |
| 2022-03-11 | Injury | None | Premature Discharge of Battery, Defective Device |
| 2022-03-09 | Injury | None | Premature Discharge of Battery, Battery Problem |
| 2022-03-07 | Injury | None | Premature Discharge of Battery, Battery Problem |
| 2022-03-04 | Injury | None | Premature Discharge of Battery, Battery Problem |
| 2022-03-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-02-28 | Malfunction | None | Premature Discharge of Battery |
| 2022-02-28 | Injury | None | Defective Device, Device Sensing Problem |
| 2022-02-24 | Injury | None | Premature Discharge of Battery, Defective Device |
| 2022-02-20 | Injury | None | Pacing Problem, Under-Sensing |
| 2022-02-17 | Injury | None | Premature Discharge of Battery |
| 2022-02-16 | Injury | None | Premature Discharge of Battery, Battery Problem |
| 2022-02-14 | Injury | None | Incorrect, Inadequate or Imprecise Result or Readings |
| 2022-02-09 | Malfunction | None | High impedance, High Capture Threshold |
| 2022-02-08 | Malfunction | No Clinical Signs, Symptoms or Conditions | Signal Artifact/Noise, High impedance, Over-Sensing, Failure to Read Input Signal |
| 2022-02-03 | Malfunction | None | False Positive Result, Over-Sensing, Low impedance |
| 2022-01-29 | Malfunction | None | Defective Device |
| 2022-01-24 | Injury | None | Signal Artifact/Noise, High impedance, Over-Sensing |
| 2022-01-21 | Malfunction | None | Signal Artifact/Noise, Premature Discharge of Battery, High impedance, Over-Sensing |
| 2022-01-19 | Malfunction | None | Signal Artifact/Noise, Over-Sensing, Pacing Problem |
| 2022-01-17 | Malfunction | None | Premature Discharge of Battery |
| 2022-01-11 | Injury | None | Premature Discharge of Battery, Battery Problem |
| 2022-01-11 | Injury | None | Premature Discharge of Battery |
| 2022-01-07 | Injury | None | Premature Discharge of Battery, Battery Problem |
| 2022-01-07 | Injury | None | Premature Discharge of Battery |
| 2022-01-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2021-12-27 | Injury | None | Premature Discharge of Battery |
| 2021-12-02 | Injury | No Clinical Signs, Symptoms or Conditions | Defective Device, Device Sensing Problem |
| 2021-10-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2021-09-20 | Injury | None | High impedance |
| 2021-09-09 | Malfunction | None | Signal Artifact/Noise, Over-Sensing, Pacing Problem |
| 2021-07-03 | Malfunction | None | Failure to Capture, High impedance, Failure to Read Input Signal, Low impedance, High Capture Threshold |
| 2021-04-27 | Malfunction | None | Defective Device |
| 2021-03-29 | Malfunction | None | Low impedance |
| 2021-02-17 | Malfunction | Device Overstimulation of Tissue, Tachycardia, Twitching, Discomfort, Cramp(s) /Muscle Spasm(s) | Signal Artifact/Noise, Over-Sensing, Pocket Stimulation |
| 2020-11-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | Signal Artifact/Noise, Pacing Problem, Failure to Read Input Signal, Under-Sensing |
| 2019-09-30 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2019-09-20 | Injury | None | Premature Discharge of Battery |
| 2019-08-23 | Injury | None | Premature Discharge of Battery |
| 2019-08-04 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2019-08-01 | Injury | None | Premature Discharge of Battery |
| 2019-07-31 | Injury | None | Premature Discharge of Battery |
| 2019-07-29 | Injury | None | High impedance, Pacing Problem, Connection Problem |
| 2019-07-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-07-17 | Injury | None | Premature Discharge of Battery |
| 2019-07-15 | Malfunction | None | Defective Device |
| 2019-07-13 | Malfunction | None | High impedance, Device Sensing Problem |
| 2019-07-09 | Injury | None | Premature Discharge of Battery |
| 2019-07-05 | Malfunction | None | Over-Sensing |
| 2019-06-27 | Malfunction | None | Premature Discharge of Battery |
| 2019-06-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-19 | Malfunction | None | Premature Discharge of Battery |
| 2019-06-15 | Injury | None | Premature Discharge of Battery, Over-Sensing |
| 2019-06-12 | Malfunction | None | Over-Sensing, Pacing Problem, Device Sensing Problem |
| 2019-06-05 | Malfunction | None | Premature Discharge of Battery |
| 2019-05-31 | Malfunction | None | Failure to Capture, Connection Problem |
| 2019-05-27 | Malfunction | None | Premature Discharge of Battery |
| 2019-05-22 | Malfunction | None | High impedance, Over-Sensing |
| 2019-05-21 | Injury | None | Migration |
| 2019-05-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-16 | Malfunction | None | Interrogation Problem |
| 2019-05-15 | Malfunction | None | Premature Discharge of Battery |
| 2019-05-10 | Malfunction | None | Premature Discharge of Battery, Defective Device |
| 2019-05-08 | Malfunction | None | Device Displays Incorrect Message |
| 2019-05-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-30 | Malfunction | None | Premature Discharge of Battery |
| 2019-04-23 | Injury | None | Premature Discharge of Battery |
| 2019-04-17 | Injury | None | Premature Discharge of Battery |
| 2019-04-17 | Injury | None | Device Displays Incorrect Message |
| 2019-04-17 | Malfunction | None | Defective Device |
| 2019-04-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-09 | Injury | None | Premature Discharge of Battery |
| 2019-03-27 | Malfunction | None | Premature Discharge of Battery |
| 2019-03-26 | Malfunction | None | Failure to Capture |
| 2019-03-24 | Malfunction | None | High impedance, Over-Sensing, Device Sensing Problem |
| 2019-03-19 | Injury | None | Failure to Capture, High Capture Threshold |
| 2019-03-18 | Injury | None | Premature Discharge of Battery |
| 2019-03-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-14 | Injury | None | Failure to Capture |
| 2019-03-14 | Injury | None | Premature Discharge of Battery |
| 2019-03-13 | Malfunction | None | Premature Discharge of Battery |
| 2019-03-11 | Injury | None | Premature Discharge of Battery |
| 2019-03-11 | Injury | None | Premature Discharge of Battery |
| 2019-02-28 | Malfunction | None | High impedance |
| 2019-02-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-24 | Injury | None | High impedance, Pacing Problem, Defective Device, Device Sensing Problem |
| 2019-02-22 | Malfunction | None | Defective Device |
| 2019-02-22 | Injury | None | Migration |
| 2019-02-18 | Injury | None | Premature Discharge of Battery |
| 2019-02-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-12 | Malfunction | None | Device Displays Incorrect Message |
| 2019-02-09 | Injury | None | Failure to Capture |
| 2019-02-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-06 | Malfunction | None | High impedance |
| 2019-02-01 | Injury | None | Signal Artifact/Noise, High impedance, Over-Sensing, Pacing Problem, Device Sensing Problem |
| 2019-02-01 | Injury | None | Premature Discharge of Battery |
| 2019-01-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-31 | Malfunction | None | High impedance, Over-Sensing |
| 2019-01-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-29 | Malfunction | None | Device Displays Incorrect Message |
| 2019-01-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-27 | Malfunction | None | High impedance, Over-Sensing, Device Sensing Problem |
| 2019-01-25 | Injury | None | Premature Discharge of Battery, Device Displays Incorrect Message |
| 2019-01-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-23 | Malfunction | None | Device Displays Incorrect Message |
| 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 |
| 2019-01-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-12-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-12-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-12-18 | Injury | None | Patient-Device Incompatibility |
| 2018-12-15 | Injury | None | Migration |
| 2018-12-11 | Malfunction | None | High impedance, Device Sensing Problem |
| 2018-12-10 | Malfunction | None | Device Displays Incorrect Message |
| 2018-12-07 | Injury | None | Premature Discharge of Battery |
| 2018-12-06 | Injury | None | High impedance, Over-Sensing, Low impedance |
| 2018-12-05 | Injury | None | High impedance, Pacing Problem |
| 2018-12-05 | Malfunction | None | Premature Discharge of Battery |
| 2018-12-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-12-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-30 | Injury | None | Defective Device |
| 2018-11-29 | Malfunction | None | Premature Discharge of Battery |
| 2018-11-27 | Malfunction | None | High impedance, Over-Sensing, Device Sensing Problem |
| 2018-11-27 | Injury | None | Premature Discharge of Battery |
| 2018-11-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-20 | Injury | None | Premature Discharge of Battery |
| 2018-11-20 | Injury | None | Premature Discharge of Battery |
| 2018-11-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-15 | Malfunction | None | Premature Discharge of Battery |
| 2018-11-14 | Malfunction | None | Failure to Capture, High impedance |
| 2018-11-13 | Malfunction | None | High impedance |
| 2018-11-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-06 | Malfunction | None | Premature Discharge of Battery |
| 2018-11-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-05 | Injury | None | Pacing Problem |
| 2018-11-05 | Injury | None | High impedance, Device Sensing Problem |
| 2018-11-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-30 | Malfunction | None | Premature Discharge of Battery |
| 2018-10-27 | Malfunction | None | Failure to Capture, Over-Sensing, Pacing Problem, Low impedance, Device Sensing Problem, High Capture Threshold |
| 2018-10-25 | Malfunction | None | Difficult to Insert |
| 2018-10-25 | Injury | None | Failure to Capture, High Capture Threshold |
| 2018-10-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-16 | Injury | None | Over-Sensing, Defective Device, Device Sensing Problem |
| 2018-10-16 | Injury | None | Defective Device |
| 2018-10-16 | Injury | None | High impedance, Over-Sensing, Pacing Problem, Device Sensing Problem |
| 2018-10-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-15 | Injury | None | Premature Discharge of Battery |
| 2018-10-12 | Injury | None | Defective Device, Patient-Device Incompatibility |
| 2018-10-08 | Injury | None | Premature Discharge of Battery |
| 2018-10-02 | Injury | None | Interrogation Problem |
| 2018-10-01 | Malfunction | None | Over-Sensing, Pacing Problem, Impedance Problem |
| 2018-09-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-21 | Injury | None | Premature Discharge of Battery |
| 2018-09-21 | Injury | None | High impedance, Over-Sensing, Connection Problem, Device Sensing Problem |
| 2018-09-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-14 | Injury | None | Failure to Capture, High impedance |
| 2018-09-13 | Malfunction | None | Premature Discharge of Battery, High impedance |
| 2018-09-13 | Injury | None | Premature Discharge of Battery |
| 2018-09-13 | Injury | None | Failure to Capture, High Capture Threshold |
| 2018-09-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-30 | Injury | None | Premature Discharge of Battery |
| 2018-08-17 | Injury | None | Premature Discharge of Battery, Capturing Problem |
| 2018-08-15 | Malfunction | None | High impedance, Over-Sensing, Device Sensing Problem |
| 2018-08-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-11 | Injury | None | Migration or Expulsion of Device |
| 2018-08-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-31 | Malfunction | None | Pacing Problem |
| 2018-07-30 | Injury | None | Failure to Capture |
| 2018-07-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-25 | Injury | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2018-07-20 | Malfunction | None | Pacing Problem, Low impedance, Ambient Noise Problem |
| 2018-07-20 | Injury | None | Connection Problem |
| 2018-07-17 | Malfunction | None | Pacing Problem, Contamination /Decontamination Problem |
| 2018-07-16 | Malfunction | None | Premature Discharge of Battery |
| 2018-07-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-13 | Malfunction | None | Over-Sensing, Fitting Problem, Ambient Noise Problem, Connection Problem |
| 2018-07-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-12 | Injury | None | Device Displays Incorrect Message |
| 2018-07-12 | Injury | None | Premature Discharge of Battery |
| 2018-07-10 | Malfunction | None | High impedance |
| 2018-06-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-25 | Injury | None | Failure to Capture, Capturing Problem |
| 2018-06-20 | Malfunction | None | Connection Problem |
| 2018-06-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-20 | Injury | None | Premature Discharge of Battery, Communication or Transmission Problem |
| 2018-06-18 | Injury | None | Defective Device |
| 2018-06-07 | Malfunction | None | Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2018-05-30 | Injury | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2018-05-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-18 | Injury | None | Defective Device |
| 2018-05-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-09 | Malfunction | None | High impedance |
| 2018-05-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-04 | Injury | None | Defective Device |
| 2018-04-30 | Injury | None | Over-Sensing, Ambient Noise Problem |
| 2018-04-19 | Injury | None | Device Operates Differently Than Expected |
| 2018-04-16 | Injury | None | Failure to Capture, High impedance, Ambient Noise Problem, Capturing Problem |
| 2018-04-15 | Malfunction | None | Impedance Problem, High Capture Threshold |
| 2018-04-13 | Injury | None | Device Operates Differently Than Expected |
| 2018-04-10 | Malfunction | None | Failure to Capture |
| 2018-04-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-01 | Injury | None | Defective Device |
| 2018-04-01 | Injury | None | High impedance, Pacing Problem, High Capture Threshold |
| 2018-04-01 | Malfunction | None | Ambient Noise Problem |
| 2018-03-29 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2018-03-28 | Malfunction | None | Premature Discharge of Battery |
| 2018-03-24 | Injury | None | Failure to Capture, Capturing Problem, Device Operates Differently Than Expected |
| 2018-03-21 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2018-03-21 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-19 | Injury | None | Premature Discharge of Battery |
| 2018-03-13 | Malfunction | None | Fitting Problem |
| 2018-03-13 | Injury | None | Failure to Capture, Failure to Sense |
| 2018-03-11 | Injury | None | Failure to Capture, Use of Device Problem, Device Operates Differently Than Expected |
| 2018-03-09 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-03-08 | Malfunction | None | Over-Sensing, Ambient Noise Problem |
| 2018-03-08 | Injury | None | Device Operates Differently Than Expected |
| 2018-03-06 | Injury | None | Defective Device |
| 2018-03-05 | Injury | None | Impedance Problem |
| 2018-03-01 | Malfunction | None | High impedance, Over-Sensing, Device Sensing Problem |
| 2018-02-22 | 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 |
| 2018-02-20 | Malfunction | None | High impedance, Over-Sensing |
| 2018-02-15 | Injury | None | Failure to Capture, High impedance, Capturing Problem |
| 2018-02-13 | Injury | None | Premature Discharge of Battery, Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2018-02-11 | Malfunction | None | Defective Device |
| 2018-02-09 | Malfunction | None | Over-Sensing, Ambient Noise Problem |
| 2018-02-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-02-03 | Injury | None | Defective Device |
| 2018-02-01 | Injury | None | Premature Discharge of Battery, Pacing Problem, Communication or Transmission Problem |
| 2018-01-31 | Injury | None | Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2018-01-26 | Injury | None | Device Displays Incorrect Message |
| 2018-01-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-18 | Malfunction | None | Connection Problem |
| 2018-01-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-12 | Malfunction | None | Connection Problem |
| 2018-01-12 | Injury | None | Device Operates Differently Than Expected |
| 2018-01-08 | Injury | None | Failure to Capture |
| 2018-01-05 | Malfunction | None | Ambient Noise Problem |
| 2018-01-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-12-26 | Injury | None | Migration or Expulsion of Device, Pacing Problem |
| 2017-12-26 | Injury | None | Defective Device |
| 2017-12-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-12-19 | Malfunction | None | Failure to Capture, Ambient Noise Problem, Impedance Problem |
| 2017-12-19 | Injury | None | Ambient Noise Problem, Capturing Problem, Device Operates Differently Than Expected |
| 2017-12-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-12-01 | Malfunction | None | High impedance, Over-Sensing, Pacing Problem |
| 2017-12-01 | Injury | None | Premature Discharge of Battery, Incorrect, Inadequate or Imprecise Result or Readings, Battery Problem |
| 2017-12-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-11-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-11-25 | Malfunction | None | Low impedance, Ambient Noise Problem, Device Operates Differently Than Expected |
| 2017-11-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-11-21 | Injury | None | Pacing Problem |
| 2017-11-21 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2017-11-15 | Malfunction | None | Device Displays Incorrect Message |
| 2017-11-10 | Malfunction | None | Failure to Capture, High impedance |
| 2017-11-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-11-08 | Malfunction | None | Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2017-11-06 | Injury | None | Low impedance |
| 2017-11-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-11-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-22 | Death | None | Communication or Transmission Problem |
| 2017-10-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-18 | Injury | None | Over-Sensing, Pacing Problem |
| 2017-10-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-11 | Malfunction | None | Over-Sensing, Ambient Noise Problem |
| 2017-10-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-09 | Malfunction | None | High impedance |
| 2017-10-06 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-10-01 | Malfunction | None | Failure to Capture, High impedance, Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2017-10-01 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2017-09-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-09-29 | Malfunction | None | High impedance |
| 2017-09-28 | Injury | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2017-09-21 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2017-09-17 | Injury | None | Migration or Expulsion of Device, Pacing Problem |
| 2017-09-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-09-08 | Malfunction | None | Connection Problem |
| 2017-09-08 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2017-09-07 | Injury | None | Device Operates Differently Than Expected |
| 2017-09-06 | Injury | None | Signal Artifact/Noise, Failure to Capture, High impedance, Ambient Noise Problem, Device Sensing Problem |
| 2017-09-05 | Injury | None | Under-Sensing |
| 2017-09-01 | Injury | None | Migration or Expulsion of Device |
| 2017-09-01 | Injury | None | Premature Discharge of Battery, High impedance |
| 2017-09-01 | Malfunction | None | Electrical /Electronic Property Problem |
| 2017-08-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-08-25 | Injury | None | Pacing Problem |
| 2017-08-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-08-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-08-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-08-14 | Malfunction | None | High impedance, Ambient Noise Problem |
| 2017-08-11 | Injury | None | Failure to Capture |
| 2017-08-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-08-02 | Malfunction | None | Electrical /Electronic Property Problem, High impedance, Over-Sensing, Ambient Noise Problem |
| 2017-07-31 | Malfunction | None | High impedance |
| 2017-07-24 | Malfunction | None | Device Displays Incorrect Message |
| 2017-07-24 | Injury | None | High impedance, Over-Sensing, Ambient Noise Problem, Connection Problem |
| 2017-07-21 | Injury | None | Device Operates Differently Than Expected |
| 2017-07-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-07-19 | Injury | None | Failure to Capture, Capturing Problem |
| 2017-07-19 | Injury | None | Premature Discharge of Battery |
| 2017-07-17 | Malfunction | None | Connection Problem |
| 2017-07-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-07-14 | Injury | None | Use of Device Problem, Adverse Event Without Identified Device or Use Problem |
| 2017-07-13 | Injury | None | Failure to Capture |
| 2017-07-12 | Injury | None | Device Operates Differently Than Expected |
| 2017-07-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-07-05 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2017-07-05 | Malfunction | None | Over-Sensing, Ambient Noise Problem, Impedance Problem |
| 2017-06-22 | Malfunction | None | High impedance, Over-Sensing, Under-Sensing, Ambient Noise Problem |
| 2017-06-19 | Injury | None | Failure to Capture |
| 2017-06-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-06-13 | Malfunction | None | Device Displays Incorrect Message |
| 2017-06-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-06-11 | Injury | None | Failure to Capture, High impedance, Over-Sensing, Ambient Noise Problem, Connection Problem |
| 2017-06-10 | Injury | None | Over-Sensing, Pacing Problem |
| 2017-06-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-06-01 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2017-05-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-05-30 | Malfunction | None | Connection Problem |
| 2017-05-27 | Injury | None | Over-Sensing, Pacing Problem |
| 2017-05-24 | Malfunction | None | High impedance, Over-Sensing |
| 2017-05-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-05-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-05-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-05-05 | Malfunction | None | Impedance Problem |
| 2017-05-04 | Injury | None | Premature Discharge of Battery |
| 2017-05-02 | Injury | None | Device Operates Differently Than Expected |
| 2017-05-01 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2017-04-27 | Malfunction | None | High impedance, Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2017-04-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-04-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-04-18 | Injury | None | Ambient Noise Problem |
| 2017-04-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-04-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-04-11 | Malfunction | None | High impedance, Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2017-03-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-10 | Injury | None | Premature Discharge of Battery, Device Displays Incorrect Message |
| 2017-03-10 | Injury | None | Failure to Capture, High impedance, Pacing Problem, Capturing Problem |
| 2017-03-06 | Malfunction | None | High impedance |
| 2017-03-01 | Injury | None | Premature Discharge of Battery |
| 2017-03-01 | Injury | None | Device Operates Differently Than Expected |
| 2017-01-31 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-30 | Injury | None | High impedance, Loose or Intermittent Connection, Ambient Noise Problem |
| 2017-01-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-04 | Malfunction | None | Failure to Capture, Pacing Problem, Low impedance |
| 2016-12-29 | Injury | None | Failure to Capture |
| 2016-12-27 | Malfunction | None | Failure to Capture, High impedance, Over-Sensing, Pacing Problem, Device Displays Incorrect Message, Ambient Noise Problem, Connection Problem |
| 2016-12-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-12-19 | Injury | None | Failure to Capture, Pacing Problem, Capturing Problem |
| 2016-12-15 | Injury | None | Failure to Capture, High impedance, Use of Device Problem |
| 2016-12-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-12-11 | Malfunction | None | High impedance, Over-Sensing, Ambient Noise Problem |
| 2016-12-06 | Injury | None | Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2016-11-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-11-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-11-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-11-10 | Malfunction | None | Over-Sensing, Device Contamination With Biological Material |
| 2016-10-22 | Injury | None | Insufficient Information |
| 2016-09-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-09-16 | Injury | None | Premature Discharge of Battery, Device Displays Incorrect Message |
| 2016-09-09 | Malfunction | None | Pacing Problem, Fitting Problem |
| 2016-09-01 | Malfunction | None | Over-Sensing, Pacing Problem, Ambient Noise Problem |
| 2016-08-30 | Malfunction | None | Migration or Expulsion of Device |
| 2016-08-27 | Malfunction | None | Premature Discharge of Battery |
| 2016-07-15 | Injury | None | Device Operates Differently Than Expected |
| 2016-07-15 | Injury | None | Device Operates Differently Than Expected |
| 2016-07-13 | Injury | None | Device Operates Differently Than Expected |
| 2016-07-07 | Malfunction | None | High impedance |
| 2016-06-16 | Malfunction | None | Connection Problem |
| 2016-05-25 | Malfunction | None | Fitting Problem, Ambient Noise Problem |