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 - NEUROMODULATION (PUERTO RICO ) and others.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Infection | 1 | Patient |
| 2024 | Insufficient Information | 1 | Patient |
| 2024 | Discomfort | 1 | Patient |
| 2024 | Premature Discharge of Battery | 3 | Device |
| 2024 | Pacing Problem | 3 | Device |
| 2024 | Over-Sensing | 3 | Device |
| 2024 | Migration | 1 | Device |
| 2024 | Loose or Intermittent Connection | 1 | Device |
| 2024 | Incorrect Measurement | 1 | Device |
| 2024 | Failure to Disconnect | 1 | Device |
| 2024 | Capturing Problem | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2023 | Unspecified Infection | 2 | Patient |
| 2023 | Pocket Erosion | 1 | Patient |
| 2023 | Discomfort | 1 | Patient |
| 2023 | Under-Sensing | 1 | Device |
| 2023 | Premature Discharge of Battery | 1 | Device |
| 2023 | Pacing Problem | 2 | Device |
| 2023 | Pacemaker Found in Back-Up Mode | 6 | Device |
| 2023 | Over-Sensing | 2 | Device |
| 2023 | Loose or Intermittent Connection | 3 | Device |
| 2023 | Incorrect Measurement | 2 | Device |
| 2023 | Inappropriate or Unexpected Reset | 1 | Device |
| 2023 | Failure to Interrogate | 1 | Device |
| 2023 | Failure to Disconnect | 3 | Device |
| 2023 | Failure to Capture | 1 | Device |
| 2023 | Environmental Compatibility Problem | 1 | Device |
| 2023 | Difficult to Remove | 1 | Device |
| 2023 | Contamination of Device Ingredient or Reagent | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2022 | Unspecified Infection | 1 | Patient |
| 2022 | Under-Sensing | 3 | Device |
| 2022 | Therapy Delivered to Incorrect Body Area | 2 | Device |
| 2022 | Tactile Prompts/Feedback | 1 | Device |
| 2022 | Premature Discharge of Battery | 1 | Device |
| 2022 | Pacing Problem | 1 | Device |
| 2022 | Pacemaker Found in Back-Up Mode | 5 | Device |
| 2022 | Over-Sensing | 3 | Device |
| 2022 | No Audible Prompt/Feedback | 1 | Device |
| 2022 | Insufficient Information | 1 | Device |
| 2022 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2022 | Incorrect Measurement | 4 | Device |
| 2022 | Failure to Interrogate | 1 | Device |
| 2022 | Failure to Disconnect | 3 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2021 | Insufficient Information | 1 | Patient |
| 2021 | Hypersensitivity/Allergic reaction | 1 | Patient |
| 2021 | Insufficient Information | 1 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2020 | Hypersensitivity/Allergic reaction | 1 | Patient |
| 2020 | Adverse Event Without Identified Device or Use Problem | 1 | Device |