IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
This device is manufactured by BOSTON SCIENTIFIC, BOSTON SCIENTIFIC CORPORATION, CPI - DEL CARIBE, UNKNOWN.
The following problems were reported about this device:
| Date | Event Type | Patient Problem | Device Problem |
|---|---|---|---|
| 2024-07-22 | Malfunction | Device Overstimulation of Tissue | None |
| 2024-07-03 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2024-07-02 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture, High Capture Threshold |
| 2024-06-20 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2024-06-19 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture |
| 2024-06-17 | Injury | No Clinical Signs, Symptoms or Conditions | Failure to Capture, Device Dislodged or Dislocated |
| 2024-06-17 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture |
| 2024-06-14 | Injury | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2024-06-10 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2024-06-07 | Malfunction | Device Overstimulation of Tissue | Failure to Capture, High Capture Threshold |
| 2024-06-03 | Injury | No Clinical Signs, Symptoms or Conditions | Failure to Capture |
| 2024-05-30 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2024-05-30 | Injury | No Clinical Signs, Symptoms or Conditions | Failure to Capture, Under-Sensing, Device Dislodged or Dislocated |
| 2024-05-29 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2024-05-28 | Malfunction | No Clinical Signs, Symptoms or Conditions | Signal Artifact/Noise, Fracture, High impedance |
| 2024-05-28 | Injury | Bacterial Infection | Adverse Event Without Identified Device or Use Problem |
| 2024-05-24 | Malfunction | No Clinical Signs, Symptoms or Conditions | Positioning Problem, No Apparent Adverse Event |
| 2024-05-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance |
| 2024-05-15 | Injury | No Clinical Signs, Symptoms or Conditions | Defective Device |
| 2024-05-13 | Injury | No Clinical Signs, Symptoms or Conditions | Failure to Capture, Device Dislodged or Dislocated |
| 2024-05-12 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance |
| 2024-05-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture, High Capture Threshold |
| 2024-05-07 | Malfunction | Dizziness | Failure to Capture |
| 2024-05-02 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance |
| 2024-04-26 | Injury | No Clinical Signs, Symptoms or Conditions | Failure to Capture |
| 2024-04-26 | Injury | Unspecified Infection, Sepsis | Adverse Event Without Identified Device or Use Problem |
| 2024-04-26 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2024-04-25 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2024-04-21 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture |
| 2024-04-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture, Failure to Read Input Signal |
| 2024-04-17 | Injury | No Clinical Signs, Symptoms or Conditions | No Apparent Adverse Event |
| 2024-04-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2024-04-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture, High Capture Threshold |
| 2024-04-15 | Injury | No Clinical Signs, Symptoms or Conditions | Failure to Capture, High Capture Threshold |
| 2024-04-12 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2024-04-12 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2024-04-12 | Death | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2024-04-12 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2024-04-12 | Injury | Erosion, Unspecified Infection, No Clinical Signs, Symptoms or Conditions | Failure to Capture, Defective Device, Device Dislodged or Dislocated, High Capture Threshold |
| 2024-04-05 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2024-04-04 | Injury | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2024-04-04 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2024-04-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture |
| 2024-03-25 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-20 | Injury | Bacterial Infection | None |
| 2024-03-20 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-13 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-09 | Malfunction | Bradycardia, Syncope/Fainting | None |
| 2024-03-06 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-06 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2024-03-06 | Injury | Device Overstimulation of Tissue | None |
| 2024-03-06 | Injury | Purulent Discharge, Unspecified Infection, Swelling/ Edema | None |
| 2024-02-29 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-02-28 | Injury | Chest Pain, Pleural Effusion, Cardiac Tamponade, Cardiac Perforation, Vascular Dissection | Failure to Capture, Device Dislodged or Dislocated, Positioning Problem |
| 2024-02-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | None |
| 2024-02-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture |
| 2024-02-21 | Injury | Device Overstimulation of Tissue | Device Dislodged or Dislocated |
| 2024-02-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | No Apparent Adverse Event |
| 2024-02-15 | Malfunction | Device Overstimulation of Tissue | Pocket Stimulation, High Capture Threshold |
| 2024-02-13 | Injury | No Clinical Signs, Symptoms or Conditions | Failure to Capture |
| 2024-02-13 | Injury | No Clinical Signs, Symptoms or Conditions | Defective Device |
| 2024-02-09 | Injury | Device Overstimulation of Tissue, Discomfort | No Apparent Adverse Event |
| 2024-02-09 | Injury | Undesired Nerve Stimulation, No Clinical Signs, Symptoms or Conditions | Failure to Capture, High Capture Threshold |
| 2024-02-09 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2024-02-09 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2024-02-09 | Injury | Wound Dehiscence, Unspecified Infection, Impaired Healing, Swelling/ Edema | Adverse Event Without Identified Device or Use Problem |
| 2024-02-05 | Malfunction | No Clinical Signs, Symptoms or Conditions | Defective Device |
| 2024-02-01 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2024-01-29 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2024-01-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | No Apparent Adverse Event |
| 2024-01-19 | Injury | Device Overstimulation of Tissue | Device Dislodged or Dislocated |
| 2024-01-17 | Injury | No Clinical Signs, Symptoms or Conditions | Connection Problem |
| 2024-01-12 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2024-01-12 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2024-01-12 | Malfunction | Device Overstimulation of Tissue | Failure to Capture, Pocket Stimulation |
| 2024-01-04 | Death | Low Blood Pressure/ Hypotension, Unspecified Infection, Sepsis | Difficult to Remove, Adverse Event Without Identified Device or Use Problem |
| 2024-01-04 | Injury | No Clinical Signs, Symptoms or Conditions | High Capture Threshold |
| 2024-01-02 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance |
| 2023-12-28 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture, Device Dislodged or Dislocated |
| 2023-12-28 | Injury | Device Overstimulation of Tissue, Unspecified Heart Problem | High impedance, Unexpected Therapeutic Results |
| 2023-12-27 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2023-12-26 | Malfunction | Bradycardia, Device Overstimulation of Tissue | Over-Sensing, Pacing Problem, Device Dislodged or Dislocated, High Capture Threshold |
| 2023-12-26 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance |
| 2023-12-22 | Injury | Unspecified Infection | None |
| 2023-12-20 | Injury | Device Overstimulation of Tissue, No Clinical Signs, Symptoms or Conditions | Pocket Stimulation, Defective Device |
| 2023-12-15 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture, Failure to Read Input Signal, Device Dislodged or Dislocated, High Capture Threshold |
| 2023-12-14 | Injury | Unspecified Infection | None |
| 2023-12-14 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-12-14 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2023-12-14 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-12-14 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance |
| 2023-12-13 | Injury | Unspecified Infection | None |
| 2023-12-10 | Injury | No Clinical Signs, Symptoms or Conditions | None |
| 2023-11-03 | Injury | Unspecified Infection, Sepsis | Adverse Event Without Identified Device or Use Problem |
| 2023-11-03 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-10-20 | Malfunction | No Clinical Signs, Symptoms or Conditions | Material Integrity Problem |
| 2023-10-19 | Injury | Device Overstimulation of Tissue | Defective Device |
| 2023-10-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture |
| 2023-10-16 | Malfunction | No Clinical Signs, Symptoms or Conditions | Over-Sensing, Pacing Problem, Migration |
| 2023-10-11 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-10-04 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance, Connection Problem |
| 2023-10-03 | Injury | Device Overstimulation of Tissue, Loss of consciousness | Failure to Capture, Pocket Stimulation |
| 2023-10-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | Signal Artifact/Noise, Failure to Capture, High impedance, Over-Sensing, Device Sensing Problem |
| 2023-10-02 | Injury | No Clinical Signs, Symptoms or Conditions | Over-Sensing |
| 2023-10-02 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-09-28 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture |
| 2023-09-28 | Malfunction | No Clinical Signs, Symptoms or Conditions | No Apparent Adverse Event |
| 2023-09-28 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-09-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture, Over-Sensing |
| 2023-09-25 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-09-22 | Injury | Device Overstimulation of Tissue | Failure to Capture |
| 2023-09-22 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-09-20 | Injury | Bacterial Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-09-19 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-09-12 | Injury | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2023-09-02 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance |
| 2023-09-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance |
| 2023-08-31 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture, High Capture Threshold |
| 2023-08-31 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture, High impedance, Failure to Read Input Signal, High Capture Threshold |
| 2023-08-30 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture, Failure to Read Input Signal |
| 2023-08-25 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-08-24 | Injury | Bacterial Infection, Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-08-18 | Injury | No Clinical Signs, Symptoms or Conditions | Failure to Capture, Device Dislodged or Dislocated |
| 2023-08-11 | Injury | Abscess, Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-08-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance |
| 2023-08-08 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-08-04 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2023-08-04 | Injury | No Clinical Signs, Symptoms or Conditions | Failure to Capture, Device Dislodged or Dislocated |
| 2023-08-03 | Malfunction | No Clinical Signs, Symptoms or Conditions | High impedance |
| 2023-08-01 | Injury | No Clinical Signs, Symptoms or Conditions | Signal Artifact/Noise |
| 2023-07-31 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture |
| 2023-07-31 | Malfunction | No Clinical Signs, Symptoms or Conditions | Defective Device |
| 2023-07-31 | Malfunction | Asystole | Signal Artifact/Noise, High impedance, Over-Sensing, Pacing Problem |
| 2023-07-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture, Difficult to Insert |
| 2023-07-26 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-07-26 | Injury | No Clinical Signs, Symptoms or Conditions | Defective Device, Device Dislodged or Dislocated, High Capture Threshold |
| 2023-07-25 | Injury | Syncope/Fainting | Failure to Capture, High Capture Threshold |
| 2023-07-25 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2023-07-24 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-07-17 | Injury | No Clinical Signs, Symptoms or Conditions | Failure to Capture, Device Dislodged or Dislocated |
| 2023-07-14 | Malfunction | Device Overstimulation of Tissue | Signal Artifact/Noise, Defective Device, Impedance Problem |
| 2023-07-13 | Injury | Device Overstimulation of Tissue | Device Dislodged or Dislocated |
| 2023-07-10 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-06-30 | Injury | Device Overstimulation of Tissue | No Apparent Adverse Event |
| 2023-06-26 | Injury | Unspecified Infection, Sepsis | Adverse Event Without Identified Device or Use Problem |
| 2023-06-20 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2023-06-15 | Injury | Device Overstimulation of Tissue | Device Dislodged or Dislocated |
| 2023-06-10 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture |
| 2023-06-03 | Injury | Device Overstimulation of Tissue, Unspecified Heart Problem | Adverse Event Without Identified Device or Use Problem |
| 2023-06-01 | Injury | Undesired Nerve Stimulation, Device Overstimulation of Tissue | No Apparent Adverse Event |
| 2023-05-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture |
| 2023-05-11 | Injury | Unspecified Infection, Sepsis | Adverse Event Without Identified Device or Use Problem |
| 2023-04-24 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture, Failure to Read Input Signal, Device Dislodged or Dislocated |
| 2023-04-14 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2023-04-12 | Injury | Device Overstimulation of Tissue | No Apparent Adverse Event |
| 2023-04-10 | Injury | Insufficient Information | Failure to Capture, High Capture Threshold |
| 2023-03-30 | Injury | No Clinical Signs, Symptoms or Conditions | Failure to Capture, Device Dislodged or Dislocated |
| 2023-03-18 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture |
| 2023-03-13 | Injury | Low Blood Pressure/ Hypotension, Perforation, Cardiac Tamponade | Positioning Problem |
| 2023-03-08 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-03-07 | Injury | Fatigue, Unspecified Heart Problem, No Clinical Signs, Symptoms or Conditions | Failure to Capture, Device Dislodged or Dislocated, No Apparent Adverse Event |
| 2023-03-06 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2023-02-27 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-02-18 | Injury | No Clinical Signs, Symptoms or Conditions | Failure to Capture |
| 2023-02-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | Difficult to Insert, No Apparent Adverse Event |
| 2023-01-31 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-01-24 | Injury | Unspecified Infection, Sepsis | Adverse Event Without Identified Device or Use Problem |
| 2023-01-19 | Injury | Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-01-17 | Injury | Fever, Unspecified Infection | Adverse Event Without Identified Device or Use Problem |
| 2023-01-16 | Injury | No Clinical Signs, Symptoms or Conditions | Failure to Capture, Off-Label Use, Device Dislodged or Dislocated |
| 2023-01-11 | Injury | No Clinical Signs, Symptoms or Conditions | Adverse Event Without Identified Device or Use Problem |
| 2023-01-10 | Injury | No Clinical Signs, Symptoms or Conditions | Device Dislodged or Dislocated |
| 2023-01-10 | Malfunction | Unspecified Heart Problem | High impedance |
| 2022-12-27 | Malfunction | No Clinical Signs, Symptoms or Conditions | No Apparent Adverse Event |
| 2022-12-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-12-13 | Death | Cardiac Tamponade | Adverse Event Without Identified Device or Use Problem |
| 2022-12-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-12-09 | Injury | None | Device Dislodged or Dislocated |
| 2022-12-09 | Injury | None | Device Dislodged or Dislocated |
| 2022-12-06 | Malfunction | No Clinical Signs, Symptoms or Conditions | Over-Sensing, Pacing Problem, Off-Label Use, Adverse Event Without Identified Device or Use Problem |
| 2022-12-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture, Low impedance, High Capture Threshold |
| 2022-11-02 | Injury | None | Signal Artifact/Noise, Failure to Capture, High impedance, High Capture Threshold |
| 2022-11-02 | Injury | None | Failure to Capture, Device Dislodged or Dislocated |
| 2022-11-01 | Injury | None | High Capture Threshold |
| 2022-11-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-10-27 | Malfunction | None | Positioning Problem, No Apparent Adverse Event |
| 2022-10-26 | Malfunction | None | No Apparent Adverse Event |
| 2022-10-25 | Malfunction | None | Failure to Capture |
| 2022-10-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-10-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-10-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-10-10 | Injury | None | Failure to Capture, Difficult to Insert, Defective Device, Device Dislodged or Dislocated, High Capture Threshold |
| 2022-10-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-10-06 | Injury | None | Pocket Stimulation |
| 2022-09-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-09-15 | Injury | None | No Apparent Adverse Event |
| 2022-09-15 | Injury | None | Failure to Capture, Device Dislodged or Dislocated |
| 2022-09-13 | Injury | None | High impedance, Device Contamination with Chemical or Other Material |
| 2022-09-12 | Injury | None | No Apparent Adverse Event |
| 2022-09-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-09-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-09-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-09-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-09-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-08-31 | Injury | None | Device Dislodged or Dislocated |
| 2022-08-29 | Injury | None | No Apparent Adverse Event |
| 2022-08-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-08-01 | Malfunction | No Clinical Signs, Symptoms or Conditions | High Capture Threshold |
| 2022-07-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-07-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-05-11 | Injury | None | Failure to Capture |
| 2022-04-27 | Injury | No Clinical Signs, Symptoms or Conditions | No Apparent Adverse Event |
| 2022-04-25 | Injury | None | Failure to Capture, Over-Sensing, Device Dislodged or Dislocated |
| 2022-03-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-15 | Malfunction | None | High impedance |
| 2022-03-08 | Injury | None | Failure to Capture, Device Dislodged or Dislocated, High Capture Threshold |
| 2022-03-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-02 | Injury | None | No Apparent Adverse Event |
| 2022-03-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-03-01 | Injury | None | High Capture Threshold |
| 2022-03-01 | Injury | None | Device Dislodged or Dislocated |
| 2022-02-28 | Injury | None | High Capture Threshold |
| 2022-02-23 | Malfunction | No Clinical Signs, Symptoms or Conditions | High Sensing Threshold |
| 2022-02-23 | Injury | None | Failure to Capture, Device Dislodged or Dislocated, High Capture Threshold |
| 2022-02-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-02-15 | Injury | None | Pacing Problem, Device Dislodged or Dislocated |
| 2022-02-10 | Injury | None | Device Dislodged or Dislocated |
| 2022-02-10 | Malfunction | None | High Capture Threshold |
| 2022-02-09 | Malfunction | None | Device Dislodged or Dislocated |
| 2022-02-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-02-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-02-04 | Malfunction | None | High impedance |
| 2022-02-04 | Malfunction | None | Use of Device Problem, Defective Device, Device Dislodged or Dislocated |
| 2022-02-04 | Injury | None | Failure to Capture, High Capture Threshold |
| 2022-01-30 | Injury | None | No Apparent Adverse Event |
| 2022-01-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-01-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-01-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-01-24 | Injury | None | Device Dislodged or Dislocated |
| 2022-01-22 | Malfunction | No Clinical Signs, Symptoms or Conditions | Over-Sensing |
| 2022-01-13 | Injury | None | Device Dislodged or Dislocated, High Capture Threshold |
| 2022-01-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-01-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-01-07 | Injury | None | Failure to Capture |
| 2022-01-07 | Injury | None | Device Dislodged or Dislocated |
| 2022-01-06 | Injury | None | Device Dislodged or Dislocated |
| 2022-01-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-01-05 | Injury | None | High Capture Threshold |
| 2022-01-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2022-01-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2021-11-10 | Malfunction | None | Difficult to Remove |
| 2021-11-01 | Malfunction | Insufficient Information | Difficult to Advance, Device Dislodged or Dislocated, Impedance Problem, Material Deformation |
| 2021-08-06 | Injury | None | Failure to Capture |
| 2021-03-11 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture |
| 2019-08-22 | Injury | None | Pacing Problem, Device Dislodged or Dislocated |
| 2019-08-20 | Injury | None | Failure to Capture, Device Dislodged or Dislocated |
| 2019-08-17 | Malfunction | None | High impedance |
| 2019-08-13 | Injury | None | Defective Device |
| 2019-08-11 | Malfunction | None | High impedance |
| 2019-08-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-08-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-07-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-07-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-07-30 | Injury | None | Defective Device |
| 2019-07-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-07-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-07-23 | Injury | None | Device Dislodged or Dislocated |
| 2019-07-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-07-19 | Injury | None | Failure to Capture |
| 2019-07-17 | Malfunction | None | Failure to Capture, High Capture Threshold |
| 2019-07-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-07-11 | Injury | None | Failure to Capture, Device Dislodged or Dislocated |
| 2019-07-11 | Injury | None | High Capture Threshold |
| 2019-07-08 | Malfunction | None | Device Dislodged or Dislocated, High Capture Threshold |
| 2019-07-08 | Injury | None | Defective Device |
| 2019-07-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-07-01 | Injury | None | Device Dislodged or Dislocated, High Capture Threshold |
| 2019-06-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-24 | Injury | None | Unexpected Therapeutic Results |
| 2019-06-24 | Malfunction | None | Defective Device, High Capture Threshold |
| 2019-06-24 | Malfunction | None | Defective Device |
| 2019-06-20 | Injury | None | Failure to Capture, Device Dislodged or Dislocated |
| 2019-06-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-10 | Injury | None | Over-Sensing, Device Dislodged or Dislocated, High Capture Threshold, Migration |
| 2019-06-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-06 | Injury | None | Patient-Device Incompatibility |
| 2019-06-06 | Injury | None | Device Dislodged or Dislocated |
| 2019-06-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-06-05 | Malfunction | None | High impedance |
| 2019-06-05 | Injury | None | Device Dislodged or Dislocated, High Capture Threshold |
| 2019-06-04 | Malfunction | None | High impedance |
| 2019-06-01 | Injury | None | Patient-Device Incompatibility |
| 2019-05-28 | Injury | None | Device Dislodged or Dislocated |
| 2019-05-28 | Malfunction | None | High impedance, High Capture Threshold |
| 2019-05-25 | Injury | None | High Capture Threshold |
| 2019-05-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-23 | Injury | None | Defective Device |
| 2019-05-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-22 | Injury | None | Device Dislodged or Dislocated, High Capture Threshold |
| 2019-05-22 | Malfunction | None | Failure to Capture, High impedance |
| 2019-05-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-21 | Malfunction | None | Defective Device |
| 2019-05-19 | Malfunction | None | High impedance |
| 2019-05-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-16 | Injury | None | Device Sensing Problem |
| 2019-05-14 | Malfunction | None | Difficult to Insert, Positioning Problem |
| 2019-05-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-13 | Injury | None | Device Dislodged or Dislocated |
| 2019-05-09 | Injury | None | Device Dislodged or Dislocated |
| 2019-05-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-03 | Injury | None | Pocket Stimulation, High Capture Threshold |
| 2019-05-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-05-02 | Injury | None | Device Dislodged or Dislocated |
| 2019-05-02 | Injury | None | Defective Device |
| 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 |
| 2019-04-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-24 | Malfunction | None | Defective Device |
| 2019-04-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-22 | Injury | None | Unexpected Therapeutic Results, Device Dislodged or Dislocated |
| 2019-04-19 | Injury | None | Failure to Capture |
| 2019-04-17 | Malfunction | None | Material Integrity Problem, Positioning Problem |
| 2019-04-17 | Injury | None | Failure to Capture, Device Dislodged or Dislocated |
| 2019-04-16 | Injury | None | Defective Device |
| 2019-04-16 | Malfunction | None | Material Integrity Problem, Positioning Problem |
| 2019-04-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-12 | Injury | None | Failure to Capture, Impedance Problem |
| 2019-04-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-11 | Injury | None | Failure to Capture, High Capture Threshold |
| 2019-04-11 | Injury | None | Device Dislodged or Dislocated, High Capture Threshold |
| 2019-04-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-04-08 | Injury | None | Failure to Capture, Device Dislodged or Dislocated, High Capture Threshold |
| 2019-04-02 | Injury | None | Defective Device |
| 2019-03-29 | Injury | None | Pocket Stimulation |
| 2019-03-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-27 | Injury | None | Pacing Problem, High Capture Threshold |
| 2019-03-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-27 | Malfunction | None | High impedance, Positioning Problem, High Capture Threshold |
| 2019-03-26 | Injury | None | Device Dislodged or Dislocated |
| 2019-03-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-18 | Injury | None | Device Dislodged or Dislocated, High Capture Threshold |
| 2019-03-12 | Injury | None | Device Dislodged or Dislocated |
| 2019-03-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-07 | Injury | None | Device Dislodged or Dislocated, High Capture Threshold |
| 2019-03-07 | Injury | None | Positioning Problem |
| 2019-03-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-06 | Malfunction | None | Impedance Problem, Material Integrity Problem |
| 2019-03-06 | Injury | None | Defective Device |
| 2019-03-06 | Malfunction | None | Difficult to Insert, Positioning Problem |
| 2019-03-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-03-01 | Injury | None | Defective Device |
| 2019-03-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-26 | Injury | None | Device Dislodged or Dislocated |
| 2019-02-22 | Injury | None | Defective Device |
| 2019-02-22 | Injury | None | Device Dislodged or Dislocated |
| 2019-02-21 | Injury | None | Failure to Capture, Device Sensing Problem, Device Dislodged or Dislocated, Impedance Problem, High Capture Threshold |
| 2019-02-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-20 | Injury | None | Device Dislodged or Dislocated |
| 2019-02-20 | Injury | None | Device Dislodged or Dislocated |
| 2019-02-20 | Malfunction | None | High impedance |
| 2019-02-16 | Injury | None | Failure to Select Signal, Device Sensing Problem |
| 2019-02-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-14 | Malfunction | None | Positioning Problem |
| 2019-02-13 | Injury | None | Device Dislodged or Dislocated |
| 2019-02-11 | Injury | None | Pocket Stimulation, High Capture Threshold |
| 2019-02-11 | Malfunction | None | Difficult to Insert |
| 2019-02-11 | Malfunction | None | Material Integrity Problem |
| 2019-02-11 | Malfunction | None | Defective Device |
| 2019-02-08 | Malfunction | None | Difficult to Remove, Material Integrity Problem |
| 2019-02-08 | Injury | None | Pocket Stimulation, Difficult to Remove |
| 2019-02-08 | Injury | None | Device Dislodged or Dislocated |
| 2019-02-06 | Injury | None | Pocket Stimulation |
| 2019-02-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-02-03 | Injury | None | Device Dislodged or Dislocated |
| 2019-02-01 | Injury | None | Device Dislodged or Dislocated |
| 2019-01-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-31 | Injury | None | Device Dislodged or Dislocated, Positioning Problem |
| 2019-01-31 | Injury | None | Pocket Stimulation |
| 2019-01-31 | Injury | None | Patient-Device Incompatibility |
| 2019-01-31 | Injury | None | Device Dislodged or Dislocated |
| 2019-01-29 | Malfunction | None | Defective Device |
| 2019-01-25 | Injury | None | Patient-Device Incompatibility |
| 2019-01-25 | Injury | None | Device Dislodged or Dislocated |
| 2019-01-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-22 | Injury | None | Device Dislodged or Dislocated |
| 2019-01-21 | Injury | None | Failure to Capture, High impedance, High Capture Threshold |
| 2019-01-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-18 | Injury | None | Over-Sensing, Pacing Problem, Device Dislodged or Dislocated |
| 2019-01-17 | Injury | None | Device Dislodged or Dislocated |
| 2019-01-11 | Malfunction | None | Signal Artifact/Noise, High impedance, Failure to Sense |
| 2019-01-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2019-01-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-12-28 | Injury | None | Patient-Device Incompatibility |
| 2018-12-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-12-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-12-21 | Injury | None | Pocket Stimulation |
| 2018-12-21 | Injury | None | Device Dislodged or Dislocated |
| 2018-12-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-12-19 | Injury | None | Pocket Stimulation |
| 2018-12-19 | Injury | None | Failure to Capture, Device Dislodged or Dislocated |
| 2018-12-18 | Injury | None | Pocket Stimulation, Device Dislodged or Dislocated, High Capture Threshold |
| 2018-12-18 | Injury | None | Pocket Stimulation |
| 2018-12-17 | Injury | None | Device Dislodged or Dislocated |
| 2018-12-15 | Injury | None | High Capture Threshold |
| 2018-12-12 | Malfunction | None | Device Dislodged or Dislocated |
| 2018-12-11 | Malfunction | None | High impedance, Pocket Stimulation |
| 2018-12-11 | Malfunction | None | High impedance |
| 2018-12-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-12-07 | Injury | None | Device Dislodged or Dislocated, High Capture Threshold |
| 2018-12-06 | Injury | None | Pocket Stimulation |
| 2018-12-05 | Malfunction | None | Defective Device |
| 2018-11-29 | Malfunction | None | Device Dislodged or Dislocated |
| 2018-11-29 | Injury | None | Pocket Stimulation, High Capture Threshold |
| 2018-11-28 | Injury | None | Device Dislodged or Dislocated |
| 2018-11-27 | Malfunction | None | Device Dislodged or Dislocated |
| 2018-11-26 | Injury | None | Pocket Stimulation, High Capture Threshold |
| 2018-11-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-14 | Malfunction | None | High impedance |
| 2018-11-13 | Injury | None | Defective Device |
| 2018-11-13 | Malfunction | None | High impedance |
| 2018-11-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-12 | Malfunction | None | Difficult to Insert |
| 2018-11-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-09 | Malfunction | None | Difficult to Insert |
| 2018-11-09 | Injury | None | Pocket Stimulation |
| 2018-11-09 | Injury | None | Device Dislodged or Dislocated |
| 2018-11-08 | Injury | None | Pocket Stimulation, Device Dislodged or Dislocated |
| 2018-11-08 | Injury | None | Device Dislodged or Dislocated |
| 2018-11-07 | Injury | None | Device Dislodged or Dislocated |
| 2018-11-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-11-01 | Malfunction | None | Defective Device |
| 2018-10-31 | Malfunction | None | Failure to Capture, Device Sensing Problem |
| 2018-10-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-23 | Injury | None | Pocket Stimulation |
| 2018-10-19 | Injury | None | Pocket Stimulation |
| 2018-10-17 | Injury | None | Device Dislodged or Dislocated, High Capture Threshold |
| 2018-10-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-16 | Malfunction | None | High impedance |
| 2018-10-16 | Malfunction | None | Positioning Problem |
| 2018-10-16 | Injury | None | High impedance |
| 2018-10-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-12 | Malfunction | None | High impedance |
| 2018-10-09 | Injury | None | Failure to Capture, High impedance, Failure to Select Signal, High Capture Threshold |
| 2018-10-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-10-03 | Injury | None | Pocket Stimulation, High Capture Threshold |
| 2018-09-28 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-27 | Malfunction | None | Material Integrity Problem |
| 2018-09-27 | Malfunction | None | Device Dislodged or Dislocated |
| 2018-09-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-26 | Injury | None | Device Dislodged or Dislocated, Positioning Problem |
| 2018-09-26 | Injury | None | Failure to Capture, Defective Device, Device Dislodged or Dislocated, Positioning Problem |
| 2018-09-24 | Malfunction | None | Difficult to Insert, Contamination /Decontamination Problem, Positioning Problem |
| 2018-09-21 | Injury | None | Failure to Capture, Device Dislodged or Dislocated |
| 2018-09-21 | Injury | None | Device Dislodged or Dislocated |
| 2018-09-20 | Injury | None | Device Dislodged or Dislocated |
| 2018-09-20 | Injury | None | Positioning Problem, High Capture Threshold |
| 2018-09-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-09-10 | Malfunction | None | Material Integrity Problem |
| 2018-09-06 | Malfunction | None | High Capture Threshold |
| 2018-09-05 | Malfunction | None | High impedance |
| 2018-09-04 | Injury | None | Pocket Stimulation |
| 2018-09-04 | Injury | None | Pocket Stimulation |
| 2018-08-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-30 | Injury | None | Device Dislodged or Dislocated |
| 2018-08-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-29 | Injury | None | Failure to Capture, Pocket Stimulation, Device Dislodged or Dislocated |
| 2018-08-28 | Malfunction | None | High impedance |
| 2018-08-27 | Malfunction | None | Failure to Capture |
| 2018-08-27 | Injury | None | Capturing Problem |
| 2018-08-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-15 | Malfunction | None | High impedance, Device Dislodged or Dislocated |
| 2018-08-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-14 | Injury | None | Pocket Stimulation |
| 2018-08-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-10 | Injury | None | Device Dislodged or Dislocated |
| 2018-08-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-08-09 | Injury | None | Capturing Problem |
| 2018-08-06 | Injury | None | Failure to Capture, Device Dislodged or Dislocated, Adverse Event Without Identified Device or Use Problem |
| 2018-08-06 | Injury | None | Defective Device, Adverse Event Without Identified Device or Use Problem |
| 2018-08-06 | Injury | None | Failure to Capture, Device Dislodged or Dislocated |
| 2018-08-03 | Injury | None | Failure to Capture, Device Dislodged or Dislocated |
| 2018-08-01 | Malfunction | None | Pocket Stimulation, Device Dislodged or Dislocated |
| 2018-08-01 | Malfunction | None | High impedance |
| 2018-08-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-31 | Injury | None | Capturing Problem, Device Dislodged or Dislocated |
| 2018-07-30 | Malfunction | None | Failure to Capture, Capturing Problem |
| 2018-07-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-30 | Injury | None | Defective Device |
| 2018-07-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-26 | Injury | None | Device Dislodged or Dislocated |
| 2018-07-26 | Injury | None | Positioning Problem |
| 2018-07-25 | Injury | None | Capturing Problem, Device Dislodged or Dislocated |
| 2018-07-24 | Malfunction | None | Over-Sensing |
| 2018-07-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-23 | Injury | None | Failure to Capture, Low impedance, Device Dislodged or Dislocated |
| 2018-07-20 | Injury | None | Failure to Capture, Capturing Problem, Device Dislodged or Dislocated |
| 2018-07-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-15 | Injury | None | Ambient Noise Problem, Device Dislodged or Dislocated |
| 2018-07-15 | Injury | None | Device Dislodged or Dislocated |
| 2018-07-13 | Malfunction | None | Device Dislodged or Dislocated |
| 2018-07-12 | Injury | None | Device Dislodged or Dislocated |
| 2018-07-09 | Injury | None | Pocket Stimulation, Device Dislodged or Dislocated |
| 2018-07-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-03 | Injury | None | Electrical /Electronic Property Problem, Device Dislodged or Dislocated |
| 2018-07-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-02 | Malfunction | None | Material Integrity Problem, Positioning Problem |
| 2018-07-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-07-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-29 | Injury | None | Pocket Stimulation |
| 2018-06-28 | Injury | None | Device Dislodged or Dislocated, Positioning Problem |
| 2018-06-28 | Injury | None | Device Dislodged or Dislocated |
| 2018-06-27 | Injury | None | Failure to Capture |
| 2018-06-27 | Injury | None | Failure to Capture, Device Dislodged or Dislocated, Human-Device Interface Problem |
| 2018-06-24 | Injury | None | High impedance, Pacing Problem, Device Sensing Problem |
| 2018-06-22 | Injury | None | Defective Device |
| 2018-06-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-19 | Injury | None | Device Dislodged or Dislocated |
| 2018-06-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-18 | Malfunction | None | High impedance |
| 2018-06-14 | Malfunction | None | Material Integrity Problem, Positioning Problem |
| 2018-06-14 | Injury | None | Pocket Stimulation, Difficult To Position |
| 2018-06-13 | Malfunction | None | Defective Device, Adverse Event Without Identified Device or Use Problem |
| 2018-06-12 | Injury | None | Device Dislodged or Dislocated |
| 2018-06-12 | Injury | None | Failure to Capture, Device Dislodged or Dislocated |
| 2018-06-12 | Injury | None | Failure to Capture, Device Sensing Problem, Device Dislodged or Dislocated |
| 2018-06-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-06-10 | Malfunction | None | High impedance, Ambient Noise Problem |
| 2018-06-08 | Injury | None | Failure to Capture, Device Dislodged or Dislocated |
| 2018-06-08 | Injury | None | Pocket Stimulation |
| 2018-06-04 | Malfunction | None | Pacing Problem |
| 2018-06-01 | Malfunction | None | Material Integrity Problem |
| 2018-06-01 | Malfunction | None | High impedance, Pocket Stimulation |
| 2018-05-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-30 | Injury | None | Failure to Capture, Pocket Stimulation, Device Dislodged or Dislocated |
| 2018-05-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-29 | Injury | None | Failure to Capture, Pacing Problem, Capturing Problem, Device Dislodged or Dislocated |
| 2018-05-25 | Injury | None | Device Dislodged or Dislocated |
| 2018-05-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-25 | Injury | None | Device Dislodged or Dislocated |
| 2018-05-25 | Injury | None | Device Dislodged or Dislocated |
| 2018-05-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-24 | Injury | None | Migration or Expulsion of Device, Ambient Noise Problem, Capturing Problem, Device Dislodged or Dislocated |
| 2018-05-23 | Malfunction | None | High impedance |
| 2018-05-22 | Injury | None | Capturing Problem |
| 2018-05-18 | Injury | None | Failure to Capture, Device Dislodged or Dislocated |
| 2018-05-18 | Injury | None | Failure to Capture, Capturing Problem, Device Dislodged or Dislocated |
| 2018-05-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-16 | Malfunction | None | Device Dislodged or Dislocated |
| 2018-05-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-14 | Malfunction | None | Material Integrity Problem |
| 2018-05-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-11 | Malfunction | None | Difficult To Position, Capturing Problem, Device Contamination With Biological Material |
| 2018-05-09 | Injury | None | High impedance, Pocket Stimulation, High Capture Threshold |
| 2018-05-08 | Injury | None | Capturing Problem |
| 2018-05-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-04 | Injury | None | Capturing Problem, Device Dislodged or Dislocated |
| 2018-05-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-05-01 | Malfunction | None | High impedance |
| 2018-04-30 | Malfunction | None | Material Integrity Problem |
| 2018-04-29 | Malfunction | None | High impedance |
| 2018-04-28 | Injury | None | Pocket Stimulation |
| 2018-04-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-24 | Malfunction | None | Pacing Problem |
| 2018-04-24 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-23 | Injury | None | Pocket Stimulation, Capturing Problem |
| 2018-04-20 | Injury | None | Capturing Problem, Device Dislodged or Dislocated |
| 2018-04-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-16 | Injury | None | Pocket Stimulation |
| 2018-04-15 | Malfunction | None | High impedance |
| 2018-04-11 | Injury | None | Device Dislodged or Dislocated |
| 2018-04-10 | Injury | None | Device Dislodged or Dislocated |
| 2018-04-10 | Malfunction | None | High impedance, Material Integrity Problem |
| 2018-04-09 | Injury | None | Capturing Problem, Device Dislodged or Dislocated, Material Integrity Problem |
| 2018-04-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-09 | Malfunction | None | Material Integrity Problem |
| 2018-04-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-06 | Injury | None | Failure to Capture, Device Dislodged or Dislocated |
| 2018-04-03 | Malfunction | None | Material Integrity Problem |
| 2018-04-02 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-04-02 | Malfunction | None | High impedance, Device Sensing Problem |
| 2018-03-29 | Malfunction | None | Human-Device Interface Problem |
| 2018-03-28 | Malfunction | None | High impedance |
| 2018-03-27 | Malfunction | None | Difficult To Position, Capturing Problem, Device Dislodged or Dislocated |
| 2018-03-27 | Injury | None | High impedance, Capturing Problem, Adverse Event Without Identified Device or Use Problem |
| 2018-03-26 | Injury | None | Pocket Stimulation, Device Dislodged or Dislocated |
| 2018-03-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-22 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-03-22 | Injury | None | Failure to Capture, Device Dislodged or Dislocated |
| 2018-03-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-19 | Malfunction | None | Material Integrity Problem |
| 2018-03-16 | Injury | None | Device Dislodged or Dislocated |
| 2018-03-16 | Injury | None | Device Dislodged or Dislocated |
| 2018-03-16 | Injury | None | Device Dislodged or Dislocated |
| 2018-03-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-03-15 | Injury | None | Difficult to Remove, Human-Device Interface Problem, Material Integrity Problem |
| 2018-03-15 | Injury | None | Human-Device Interface Problem |
| 2018-03-12 | Malfunction | None | Failure to Capture, Ambient Noise Problem, Capturing Problem |
| 2018-03-08 | Injury | None | Capturing Problem, Device Dislodged or Dislocated |
| 2018-03-08 | Injury | None | Difficult To Position, Capturing Problem |
| 2018-03-08 | Injury | None | Pocket Stimulation |
| 2018-03-07 | Malfunction | None | Difficult To Position, Device Contamination With Biological Material, Material Integrity Problem |
| 2018-03-07 | Injury | None | Capturing Problem, Device Dislodged or Dislocated |
| 2018-03-05 | Injury | None | Device Dislodged or Dislocated |
| 2018-03-05 | Malfunction | None | High impedance |
| 2018-03-01 | Malfunction | None | High impedance |
| 2018-03-01 | Injury | None | Pocket Stimulation |
| 2018-02-28 | Malfunction | None | Use of Device Problem, Material Integrity Problem |
| 2018-02-28 | Injury | None | Capturing Problem |
| 2018-02-27 | Malfunction | None | Device Operates Differently Than Expected |
| 2018-02-24 | Malfunction | None | Over-Sensing, Pacing Problem, Device Dislodged or Dislocated |
| 2018-02-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-02-23 | Injury | None | Failure to Capture, Device Dislodged or Dislocated |
| 2018-02-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-02-16 | Malfunction | None | Material Integrity Problem |
| 2018-02-12 | Malfunction | None | Device Alarm System, High impedance |
| 2018-02-09 | Injury | None | Failure to Capture, Capturing Problem, Adverse Event Without Identified Device or Use Problem |
| 2018-02-07 | Injury | None | Device Dislodged or Dislocated |
| 2018-02-01 | Injury | None | High impedance, Connection Problem, Material Integrity Problem |
| 2018-01-29 | Malfunction | None | Defective Device |
| 2018-01-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-25 | Injury | None | Device Operates Differently Than Expected |
| 2018-01-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-22 | Injury | None | Device Operates Differently Than Expected |
| 2018-01-19 | Injury | None | Failure to Capture, Device Dislodged or Dislocated |
| 2018-01-18 | Malfunction | None | High impedance |
| 2018-01-17 | Injury | None | Capturing Problem, Device Dislodged or Dislocated, Adverse Event Without Identified Device or Use Problem |
| 2018-01-16 | Malfunction | None | High impedance |
| 2018-01-15 | Injury | None | Failure to Capture, Device Dislodged or Dislocated |
| 2018-01-12 | Injury | None | Human-Device Interface Problem |
| 2018-01-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2018-01-11 | Malfunction | None | Ambient Noise Problem, Device Dislodged or Dislocated |
| 2018-01-09 | Malfunction | None | High impedance |
| 2018-01-08 | Injury | None | Over-Sensing, Pacing Problem, Device Contamination With Biological Material, Device Dislodged or Dislocated |
| 2018-01-01 | Injury | None | Failure to Capture, Capturing Problem, Device Dislodged or Dislocated |
| 2017-12-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-12-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-12-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-12-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-12-21 | Malfunction | None | High impedance |
| 2017-12-20 | Injury | None | Device Dislodged or Dislocated |
| 2017-12-19 | Malfunction | None | Device Operates Differently Than Expected, Adverse Event Without Identified Device or Use Problem |
| 2017-12-19 | Injury | None | Difficult To Position, Device Dislodged or Dislocated |
| 2017-12-19 | Malfunction | None | High impedance |
| 2017-12-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-12-16 | Malfunction | None | High impedance |
| 2017-12-15 | Injury | None | Failure to Capture |
| 2017-12-15 | Malfunction | None | Difficult To Position, Device Sensing Problem |
| 2017-12-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-12-14 | Malfunction | None | Impedance Problem |
| 2017-12-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-12-12 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-12-11 | Injury | None | Material Integrity 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 |
| 2017-12-07 | Malfunction | None | High impedance |
| 2017-12-07 | Malfunction | None | Capturing Problem |
| 2017-12-06 | Injury | None | Failure to Capture, Capturing Problem |
| 2017-12-01 | Injury | None | Failure to Capture, Device Dislodged or Dislocated, Human-Device Interface Problem |
| 2017-12-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-11-29 | Injury | None | Capturing Problem |
| 2017-11-28 | Malfunction | None | Device Dislodged or Dislocated |
| 2017-11-27 | Malfunction | None | Difficult To Position, Device Operates Differently Than Expected, Device Dislodged or Dislocated |
| 2017-11-27 | Malfunction | None | Material Integrity Problem |
| 2017-11-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-11-21 | Injury | None | Difficult To Position, Human-Device Interface Problem |
| 2017-11-21 | Malfunction | None | High impedance |
| 2017-11-21 | Injury | None | Capturing Problem, Human-Device Interface Problem |
| 2017-11-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-11-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-11-17 | Injury | None | Pocket Stimulation |
| 2017-11-16 | Malfunction | None | Difficult To Position |
| 2017-11-15 | Injury | None | Failure to Capture, Difficult to Remove, Device Sensing Problem, Device Dislodged or Dislocated |
| 2017-11-15 | Injury | None | Electrical /Electronic Property Problem, Difficult To Position, Device Dislodged or Dislocated, Adverse Event Without Identified Device or Use Problem |
| 2017-11-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-11-14 | Injury | None | Device Dislodged or Dislocated, Human-Device Interface Problem |
| 2017-11-13 | Malfunction | None | Capturing Problem |
| 2017-11-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-11-11 | Malfunction | None | High impedance |
| 2017-11-10 | Injury | None | Device Operates Differently Than Expected |
| 2017-11-09 | Injury | None | Device Operates Differently Than Expected |
| 2017-11-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-11-08 | Malfunction | None | High impedance |
| 2017-11-07 | Injury | None | Difficult To Position |
| 2017-11-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-11-06 | Injury | None | Device Dislodged or Dislocated |
| 2017-11-04 | Injury | None | Difficult to Remove, Adverse Event Without Identified Device or Use Problem |
| 2017-11-03 | Injury | None | Failure to Capture, Device Dislodged or Dislocated |
| 2017-11-01 | Injury | None | Device Operates Differently Than Expected, Device Dislodged or Dislocated |
| 2017-10-31 | Malfunction | None | Material Integrity Problem |
| 2017-10-30 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-25 | Malfunction | None | Device Operates Differently Than Expected |
| 2017-10-25 | Injury | None | Device Dislodged or Dislocated |
| 2017-10-24 | Death | None | Device Operates Differently Than Expected |
| 2017-10-24 | Injury | None | Failure to Capture, Device Dislodged or Dislocated |
| 2017-10-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-20 | Injury | None | Failure to Capture, Capturing Problem, Device Dislodged or Dislocated |
| 2017-10-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-13 | Malfunction | None | Difficult To Position, Capturing Problem |
| 2017-10-12 | Malfunction | None | High impedance |
| 2017-10-12 | Injury | None | Difficult To Position, Device Dislodged or Dislocated |
| 2017-10-12 | Injury | None | Pocket Stimulation |
| 2017-10-10 | Malfunction | None | Device Contamination With Biological Material, Material Integrity Problem |
| 2017-10-10 | Malfunction | None | High impedance, Pocket Stimulation, Capturing Problem |
| 2017-10-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-09 | Injury | None | Failure to Capture, Capturing Problem |
| 2017-10-09 | Malfunction | None | Device Dislodged or Dislocated |
| 2017-10-09 | Injury | None | Pocket Stimulation, Capturing Problem, Adverse Event Without Identified Device or Use Problem |
| 2017-10-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-06 | Malfunction | None | High impedance |
| 2017-10-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-10-06 | Injury | None | Device Dislodged or Dislocated |
| 2017-10-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-09-27 | Injury | None | Device Dislodged or Dislocated |
| 2017-09-27 | Injury | None | Failure to Capture, Difficult To Position, Device Dislodged or Dislocated |
| 2017-09-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-09-26 | Malfunction | None | Material Integrity Problem |
| 2017-09-22 | Malfunction | None | High impedance |
| 2017-09-22 | Injury | None | Failure to Capture, Over-Sensing, Pacing Problem, Device Dislodged or Dislocated |
| 2017-09-21 | Injury | None | Pocket Stimulation, Capturing Problem |
| 2017-09-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-09-20 | Injury | None | Failure to Capture, Difficult To Position, Device Dislodged or Dislocated |
| 2017-09-19 | Injury | None | Failure to Capture, Device Dislodged or Dislocated |
| 2017-09-14 | Injury | None | Device Operates Differently Than Expected |
| 2017-09-14 | Injury | None | Failure to Capture, Pocket Stimulation, Capturing Problem |
| 2017-09-13 | Injury | None | Failure to Capture, Device Dislodged or Dislocated |
| 2017-09-12 | Injury | None | Device Dislodged or Dislocated |
| 2017-09-11 | Injury | None | Failure to Capture |
| 2017-09-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-09-09 | Death | None | Low impedance |
| 2017-09-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-09-06 | Injury | None | Pocket Stimulation |
| 2017-09-04 | Malfunction | None | High impedance |
| 2017-08-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-08-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-08-29 | Injury | None | Capturing Problem, Device Dislodged or Dislocated |
| 2017-08-29 | Injury | None | Pocket Stimulation, Capturing Problem, Device Dislodged or Dislocated |
| 2017-08-28 | Injury | None | Pocket Stimulation, Capturing Problem |
| 2017-08-24 | Injury | None | Device Operates Differently Than Expected |
| 2017-08-23 | Injury | None | Pocket Stimulation |
| 2017-08-17 | Malfunction | None | Device Operates Differently Than Expected, Adverse Event Without Identified Device or Use Problem |
| 2017-08-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-08-11 | Injury | None | Pocket Stimulation, Capturing Problem, Device Dislodged or Dislocated |
| 2017-08-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-08-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-08-10 | Injury | None | Capturing Problem, Device Dislodged or Dislocated |
| 2017-08-04 | Malfunction | None | Difficult To Position, Material Integrity Problem |
| 2017-08-03 | Injury | None | Pocket Stimulation |
| 2017-08-02 | Injury | None | Capturing Problem |
| 2017-08-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-07-31 | Injury | None | Difficult To Position |
| 2017-07-28 | Malfunction | None | Difficult To Position, Material Integrity Problem |
| 2017-07-23 | Injury | None | Failure to Capture |
| 2017-07-21 | Injury | None | Failure to Capture, Device Dislodged or Dislocated |
| 2017-07-21 | Malfunction | None | High impedance |
| 2017-07-19 | Injury | None | Failure to Capture, Pocket Stimulation, Device Dislodged or Dislocated |
| 2017-07-19 | Injury | None | Device Dislodged or Dislocated |
| 2017-07-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-07-14 | Injury | None | Pocket Stimulation |
| 2017-07-14 | Injury | None | High impedance, Pocket Stimulation, Capturing Problem, Device Dislodged or Dislocated |
| 2017-07-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-07-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-07-12 | Injury | None | Pocket Stimulation |
| 2017-07-11 | Injury | None | Failure to Capture, Pocket Stimulation, Device Dislodged or Dislocated |
| 2017-07-10 | Malfunction | None | High impedance |
| 2017-07-10 | Malfunction | None | Device Contamination With Biological Material, Material Integrity Problem |
| 2017-07-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-07-06 | Injury | None | Capturing Problem, Material Integrity Problem, Adverse Event Without Identified Device or Use Problem |
| 2017-07-06 | Injury | None | Pocket Stimulation |
| 2017-07-05 | Injury | None | Difficult To Position, Human-Device Interface Problem |
| 2017-07-05 | Malfunction | None | High impedance, Ambient Noise Problem |
| 2017-06-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-06-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-06-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-06-28 | Injury | None | Failure to Capture, Device Dislodged or Dislocated |
| 2017-06-23 | Injury | None | Device Dislodged or Dislocated |
| 2017-06-22 | Malfunction | None | Material Integrity Problem |
| 2017-06-22 | Injury | None | Failure to Capture, Capturing Problem |
| 2017-06-22 | Injury | None | Failure to Capture, Capturing Problem, Device Dislodged or Dislocated |
| 2017-06-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-06-17 | Injury | None | Pocket Stimulation, Adverse Event Without Identified Device or Use Problem |
| 2017-06-16 | Malfunction | None | High impedance |
| 2017-06-16 | Injury | None | Device Dislodged or Dislocated |
| 2017-06-14 | Injury | None | Pocket Stimulation, Capturing Problem, Device Dislodged or Dislocated |
| 2017-06-13 | Malfunction | None | Failure to Capture |
| 2017-06-12 | Injury | None | Device Operates Differently Than Expected |
| 2017-06-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-06-08 | Injury | None | Failure to Capture, Capturing Problem |
| 2017-06-07 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-06-06 | Injury | None | Device Dislodged or Dislocated |
| 2017-06-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-06-01 | Injury | None | Failure to Capture, Capturing Problem, Device Dislodged or Dislocated |
| 2017-05-30 | Malfunction | None | High impedance |
| 2017-05-30 | Malfunction | None | Over-Sensing, Device Dislodged or Dislocated |
| 2017-05-24 | Injury | None | Failure to Capture, Device Dislodged or Dislocated |
| 2017-05-24 | Injury | None | Capturing Problem, Device Dislodged or Dislocated |
| 2017-05-23 | Injury | None | Failure to Capture, Device Dislodged or Dislocated |
| 2017-05-22 | Malfunction | None | Failure to Capture, Capturing Problem, Device Dislodged or Dislocated, Impedance Problem |
| 2017-05-19 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-05-15 | Malfunction | None | High impedance |
| 2017-05-11 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-05-11 | Injury | None | Failure to Capture, Human-Device Interface Problem |
| 2017-05-10 | Injury | None | Failure to Capture, Over-Sensing, Device Dislodged or Dislocated |
| 2017-05-09 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-05-08 | Malfunction | None | Difficult To Position, Material Integrity Problem |
| 2017-05-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-05-05 | Injury | None | Device Operates Differently Than Expected |
| 2017-05-02 | Injury | None | Material Integrity Problem |
| 2017-05-01 | Malfunction | None | Material Integrity Problem |
| 2017-05-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-05-01 | Injury | None | Failure to Capture, Device Dislodged or Dislocated |
| 2017-04-26 | Malfunction | None | Material Integrity Problem |
| 2017-04-24 | Injury | None | Device Dislodged or Dislocated |
| 2017-04-18 | Malfunction | None | High impedance, Pocket Stimulation, Capturing Problem, Device Operates Differently Than Expected |
| 2017-04-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-04-11 | Malfunction | None | Fracture, Capturing Problem, Material Integrity Problem |
| 2017-04-10 | Malfunction | None | Material Integrity Problem |
| 2017-04-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-04-04 | Injury | None | Device Operates Differently Than Expected, Adverse Event Without Identified Device or Use Problem |
| 2017-04-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-04-03 | Injury | None | Failure to Capture, Pocket Stimulation, Adverse Event Without Identified Device or Use Problem |
| 2017-03-31 | Injury | None | Pocket Stimulation |
| 2017-03-29 | Injury | None | Failure to Capture, Capturing Problem, Device Dislodged or Dislocated |
| 2017-03-29 | Injury | None | Failure to Capture, Pocket Stimulation, Device Dislodged or Dislocated |
| 2017-03-28 | Malfunction | None | Difficult To Position, Device Contamination With Biological Material |
| 2017-03-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-26 | Malfunction | None | Pocket Stimulation, Low impedance, Device Dislodged or Dislocated |
| 2017-03-25 | Malfunction | None | High impedance |
| 2017-03-22 | Injury | None | Device Dislodged or Dislocated |
| 2017-03-20 | Injury | None | Device Dislodged or Dislocated |
| 2017-03-16 | Injury | None | Difficult To Position, Device Operates Differently Than Expected |
| 2017-03-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-03-15 | Injury | None | Device Operates Differently Than Expected |
| 2017-03-08 | Malfunction | None | Material Integrity Problem |
| 2017-03-08 | Malfunction | None | High impedance |
| 2017-03-06 | Injury | None | Pocket Stimulation |
| 2017-03-03 | Injury | None | Device Operates Differently Than Expected |
| 2017-03-02 | Injury | None | Failure to Capture, Capturing Problem, Device Dislodged or Dislocated |
| 2017-02-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-02-23 | Injury | None | Capturing Problem, Device Operates Differently Than Expected, Device Dislodged or Dislocated, Impedance Problem, Adverse Event Without Identified Device or Use Problem |
| 2017-02-21 | Injury | None | Device Dislodged or Dislocated |
| 2017-02-18 | Malfunction | None | Material Integrity Problem |
| 2017-02-17 | Malfunction | None | Material Integrity Problem |
| 2017-02-15 | Injury | None | Pocket Stimulation, Capturing Problem, Device Dislodged or Dislocated |
| 2017-02-13 | Malfunction | None | Failure to Capture |
| 2017-02-10 | Injury | None | Device Operates Differently Than Expected, Device Dislodged or Dislocated |
| 2017-02-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-02-03 | Malfunction | None | High impedance |
| 2017-02-02 | Injury | None | Low impedance, Device Sensing Problem, Adverse Event Without Identified Device or Use Problem |
| 2017-02-01 | Injury | None | Pocket Stimulation, Device Dislodged or Dislocated |
| 2017-01-31 | Injury | None | Capturing Problem, Device Operates Differently Than Expected |
| 2017-01-30 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-30 | Injury | None | High impedance |
| 2017-01-27 | Malfunction | None | High impedance, Material Integrity Problem |
| 2017-01-25 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-24 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-23 | Injury | None | Pocket Stimulation, Device Dislodged or Dislocated |
| 2017-01-19 | Injury | None | Failure to Capture |
| 2017-01-19 | Malfunction | None | Kinked, Difficult To Position, Material Integrity Problem |
| 2017-01-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-17 | Injury | None | Capturing Problem, Device Dislodged or Dislocated, Adverse Event Without Identified Device or Use Problem |
| 2017-01-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-16 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2017-01-16 | Malfunction | None | High impedance |
| 2017-01-13 | Malfunction | None | Material Integrity Problem |
| 2017-01-10 | Injury | None | Pocket Stimulation |
| 2017-01-06 | Malfunction | None | High impedance |
| 2017-01-05 | Malfunction | None | High impedance |
| 2017-01-04 | Injury | None | Device Contamination With Biological Material, Adverse Event Without Identified Device or Use Problem |
| 2017-01-03 | Injury | None | Capturing Problem, Device Dislodged or Dislocated |
| 2016-12-27 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-12-26 | Malfunction | None | Capturing Problem, Device Dislodged or Dislocated, Material Integrity Problem |
| 2016-12-23 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-12-22 | Injury | None | Capturing Problem, Device Dislodged or Dislocated |
| 2016-12-21 | Malfunction | None | Material Integrity Problem |
| 2016-12-16 | Injury | None | Difficult To Position, Device Operates Differently Than Expected |
| 2016-12-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-12-12 | Injury | None | Failure to Capture, Device Sensing Problem, Device Dislodged or Dislocated |
| 2016-12-08 | Injury | None | Device Dislodged or Dislocated |
| 2016-12-02 | Injury | None | Pocket Stimulation, Device Dislodged or Dislocated |
| 2016-11-23 | Injury | None | Pocket Stimulation, Device Dislodged or Dislocated |
| 2016-11-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-11-18 | Injury | None | Capturing Problem, Device Dislodged or Dislocated |
| 2016-11-17 | Injury | None | Difficult To Position, Device Dislodged or Dislocated |
| 2016-11-16 | Malfunction | None | Failure to Capture |
| 2016-11-14 | Injury | None | Device Operates Differently Than Expected, Human-Device Interface Problem |
| 2016-11-14 | Malfunction | None | High impedance |
| 2016-11-14 | Injury | None | Pocket Stimulation |
| 2016-11-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-11-09 | Malfunction | None | High impedance |
| 2016-11-06 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-11-04 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-11-03 | Malfunction | None | High impedance, Pocket Stimulation, Capturing Problem |
| 2016-11-03 | Malfunction | None | High impedance, Use of Device Problem, Fitting Problem |
| 2016-11-02 | Injury | None | Failure to Capture, Capturing Problem, Device Dislodged or Dislocated |
| 2016-10-31 | Injury | None | Failure to Capture, Capturing Problem, Device Dislodged or Dislocated |
| 2016-10-28 | Malfunction | No Clinical Signs, Symptoms or Conditions | Failure to Capture |
| 2016-10-27 | Injury | None | High impedance, Connection Problem |
| 2016-10-21 | Malfunction | None | Material Integrity Problem |
| 2016-10-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-10-20 | Injury | None | Human-Device Interface Problem |
| 2016-10-19 | Malfunction | None | Difficult To Position, Product Quality Problem, Material Integrity Problem |
| 2016-10-18 | Malfunction | None | High impedance |
| 2016-10-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-10-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-10-10 | Injury | None | Over-Sensing, Low impedance, Ambient Noise Problem |
| 2016-10-08 | Injury | None | Failure to Capture, Device Dislodged or Dislocated |
| 2016-10-08 | Injury | None | Failure to Capture, Device Dislodged or Dislocated |
| 2016-10-07 | Injury | None | Device Dislodged or Dislocated |
| 2016-10-05 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-10-03 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-10-03 | Malfunction | None | Material Integrity Problem |
| 2016-10-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-09-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-09-28 | Injury | None | Device Dislodged or Dislocated |
| 2016-09-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-09-24 | Injury | None | Pocket Stimulation, Device Dislodged or Dislocated |
| 2016-09-22 | Injury | None | Device Operates Differently Than Expected |
| 2016-09-20 | Malfunction | None | Failure to Capture, High impedance |
| 2016-09-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-09-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-09-14 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-09-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-09-07 | Death | None | Adverse Event Without Identified Device or Use Problem |
| 2016-09-07 | Malfunction | None | Material Integrity Problem |
| 2016-09-06 | Malfunction | None | Difficult To Position, Material Integrity Problem |
| 2016-08-30 | Injury | None | Failure to Capture, Capturing Problem, Device Dislodged or Dislocated |
| 2016-08-29 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-08-26 | Injury | None | Device Dislodged or Dislocated |
| 2016-08-25 | Malfunction | None | Impedance Problem |
| 2016-08-22 | Injury | None | Failure to Capture, Device Dislodged or Dislocated |
| 2016-08-17 | Malfunction | None | Difficult To Position, Material Integrity Problem |
| 2016-08-16 | Injury | None | Pocket Stimulation, Capturing Problem, Adverse Event Without Identified Device or Use Problem |
| 2016-08-13 | Injury | None | Pacing Problem, Device Dislodged or Dislocated |
| 2016-08-10 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-08-05 | Malfunction | None | Material Integrity Problem |
| 2016-08-03 | Malfunction | None | Device Sensing Problem, Impedance Problem |
| 2016-08-01 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-07-31 | Malfunction | None | High impedance |
| 2016-07-28 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-07-28 | Injury | None | Capturing Problem |
| 2016-07-27 | Injury | None | Pacing Problem, Device Dislodged or Dislocated |
| 2016-07-27 | Injury | None | Device Dislodged or Dislocated |
| 2016-07-26 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-07-26 | Injury | None | Pocket Stimulation, Capturing Problem |
| 2016-07-26 | Injury | None | Failure to Capture, Device Dislodged or Dislocated |
| 2016-07-22 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-07-22 | Malfunction | None | Difficult To Position, Material Integrity Problem |
| 2016-07-21 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-07-20 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-07-19 | Injury | None | Device Dislodged or Dislocated |
| 2016-07-19 | Injury | None | Device Dislodged or Dislocated |
| 2016-07-18 | Injury | None | High impedance, Pocket Stimulation |
| 2016-07-15 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-07-13 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-07-08 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-07-05 | Injury | None | Pocket Stimulation, Capturing Problem, Device Dislodged or Dislocated |
| 2016-06-30 | Malfunction | None | Device Operates Differently Than Expected, Device Dislodged or Dislocated |
| 2016-06-24 | Malfunction | None | Material Integrity Problem, Adverse Event Without Identified Device or Use Problem |
| 2016-06-16 | Injury | None | Device Dislodged or Dislocated |
| 2016-06-13 | Injury | None | Failure to Capture, Electrical /Electronic Property Problem, Device Dislodged or Dislocated |
| 2016-06-10 | Malfunction | None | Device Operates Differently Than Expected |
| 2016-05-23 | Malfunction | None | Difficult To Position, Material Integrity Problem |
| 2016-05-17 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2016-05-10 | Malfunction | None | Occlusion Within Device, Product Quality Problem |
| 2016-04-27 | Malfunction | None | Failure to Capture, Capturing Problem, Device Dislodged or Dislocated |
| 2016-04-15 | Malfunction | None | Difficult To Position, Material Integrity Problem |
| 2016-04-13 | Injury | None | Device Dislodged or Dislocated |
| 2016-03-17 | Malfunction | None | Difficult To Position, Material Integrity Problem |
| 2016-02-18 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2015-12-31 | Injury | None | Adverse Event Without Identified Device or Use Problem |
| 2015-12-18 | Malfunction | None | Device Contamination With Biological Material, Material Integrity Problem |
| 2015-12-01 | Malfunction | None | Material Integrity Problem |
| 2015-09-04 | Injury | None | Capturing Problem, Device Dislodged or Dislocated, Adverse Event Without Identified Device or Use Problem |
| 2015-08-25 | Injury | None | High impedance, Pocket Stimulation |
| 2015-07-14 | Injury | None | Failure to Capture, Device Dislodged or Dislocated |
| 2015-07-08 | Injury | None | Device Dislodged or Dislocated |
| 2015-04-21 | Malfunction | None | Material Integrity Problem |
| 2015-02-16 | Injury | None | Capturing Problem, Positioning Problem |
| 2014-11-15 | Malfunction | None | Difficult To Position |
| 2014-11-15 | Malfunction | None | Difficult To Position, Material Integrity Problem |
| 2014-11-05 | Malfunction | None | Difficult To Position, Device Contamination With Biological Material |
| 2014-09-10 | Injury | None | Electrical /Electronic Property Problem |
| 2014-07-14 | Malfunction | None | Difficult To Position, Material Integrity Problem |
| 2014-04-10 | Injury | None | Failure to Capture, High impedance, Device Dislodged or Dislocated |
| 2014-03-24 | Malfunction | None | Failure to Capture, High impedance, Difficult To Position |
| 2014-03-04 | Malfunction | None | Difficult To Position, Capturing Problem, Material Integrity Problem |
| 2014-03-04 | Injury | None | Appropriate Term/Code Not Available |
| 2014-01-02 | Malfunction | None | Failure to Capture, High impedance, Connection Problem |