IMPLANTABLE PACEMAKER PULSE GENERATOR
This device is manufactured by ABBOTT, ST JUDE MEDICAL, ST JUDE MEDICAL (CRM-SUNNYVALE), ST JUDE MEDICAL (CRM-SYLMAR), ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Infection | 1 | Patient |
| 2024 | Dyspnea | 1 | Patient |
| 2024 | Discomfort | 1 | Patient |
| 2024 | Premature Discharge of Battery | 1 | Device |
| 2024 | Pacemaker Found in Back-Up Mode | 1 | Device |
| 2024 | Loose or Intermittent Connection | 1 | Device |
| 2024 | Incorrect Measurement | 2 | Device |
| 2024 | Failure to Interrogate | 1 | Device |
| 2024 | Failure to Disconnect | 2 | Device |
| 2024 | Difficult to Remove | 1 | Device |
| 2024 | Break | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2023 | Unspecified Infection | 4 | Patient |
| 2023 | Pocket Erosion | 1 | Patient |
| 2023 | Dizziness | 1 | Patient |
| 2023 | Discomfort | 2 | Patient |
| 2023 | Arrhythmia | 1 | Patient |
| 2023 | Use of Device Problem | 1 | Device |
| 2023 | Therapy Delivered to Incorrect Body Area | 1 | Device |
| 2023 | Premature Discharge of Battery | 3 | Device |
| 2023 | Pacing Asynchronously | 1 | Device |
| 2023 | Pacemaker Found in Back-Up Mode | 6 | Device |
| 2023 | No Pacing | 1 | Device |
| 2023 | Incorrect Measurement | 4 | Device |
| 2023 | Failure to Sense | 1 | Device |
| 2023 | Failure to Interrogate | 2 | Device |
| 2023 | Failure to Capture | 1 | Device |
| 2023 | Capturing Problem | 1 | Device |
| 2023 | Battery Problem | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2022 | Unspecified Infection | 1 | Patient |
| 2022 | Pocket Erosion | 1 | Patient |
| 2022 | Discomfort | 1 | Patient |
| 2022 | Under-Sensing | 1 | Device |
| 2022 | Premature Discharge of Battery | 4 | Device |
| 2022 | Pacing Problem | 2 | Device |
| 2022 | Pacemaker Found in Back-Up Mode | 7 | Device |
| 2022 | Over-Sensing | 1 | Device |
| 2022 | No Pacing | 2 | Device |
| 2022 | Loose or Intermittent Connection | 1 | Device |
| 2022 | Incorrect Measurement | 3 | Device |
| 2022 | Failure to Sense | 1 | Device |
| 2022 | Failure to Interrogate | 3 | Device |
| 2022 | Failure to Disconnect | 3 | Device |
| 2022 | Failure to Capture | 2 | Device |
| 2022 | Difficult to Remove | 1 | Device |
| 2022 | Data Problem | 1 | Device |
| 2022 | Contamination of Device Ingredient or Reagent | 1 | Device |
| 2022 | Connection Problem | 1 | Device |
| 2022 | Component Missing | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2021 | Insufficient Information | 2 | Patient |
| 2021 | Low impedance | 2 | Device |