IMPLANTABLE CARDIAC MONITOR
This device is manufactured by ABBOTT, ABBOTT CRM, ABBOTT MEDICAL, ST JUDE MEDICAL (CRM-SUNNYVALE), ST JUDE MEDICAL (CRM-SYLMAR) 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 | Under-Sensing | 12 | Device |
| 2024 | Sensing Intermittently | 1 | Device |
| 2024 | Premature Discharge of Battery | 2 | Device |
| 2024 | Over-Sensing | 6 | Device |
| 2024 | No Apparent Adverse Event | 1 | Device |
| 2024 | Migration or Expulsion of Device | 1 | Device |
| 2024 | Interrogation Problem | 2 | Device |
| 2024 | Incorrect Measurement | 1 | Device |
| 2024 | Incorrect Interpretation of Signal | 1 | Device |
| 2024 | Inappropriate or Unexpected Reset | 1 | Device |
| 2024 | Failure to Interrogate | 6 | Device |
| 2024 | Device Sensing Problem | 1 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2023 | Wound Dehiscence | 3 | Patient |
| 2023 | Unspecified Infection | 1 | Patient |
| 2023 | Scar Tissue | 1 | Patient |
| 2023 | Insufficient Information | 5 | Patient |
| 2023 | Discomfort | 1 | Patient |
| 2023 | Under-Sensing | 26 | Device |
| 2023 | Signal Artifact/Noise | 4 | Device |
| 2023 | Product Quality Problem | 1 | Device |
| 2023 | Premature Discharge of Battery | 4 | Device |
| 2023 | Over-Sensing | 12 | Device |
| 2023 | Migration or Expulsion of Device | 1 | Device |
| 2023 | Incorrect, Inadequate or Imprecise Result or Readings | 6 | Device |
| 2023 | Incorrect Measurement | 3 | Device |
| 2023 | Incorrect Interpretation of Signal | 2 | Device |
| 2023 | Inappropriate or Unexpected Reset | 2 | Device |
| 2023 | Failure to Sense | 3 | Device |
| 2023 | Failure to Interrogate | 10 | Device |
| 2023 | Device Sensing Problem | 2 | Device |
| 2023 | Detachment of Device or Device Component | 2 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2022 | Under-Sensing | 39 | Device |
| 2022 | Premature Discharge of Battery | 10 | Device |
| 2022 | Over-Sensing | 22 | Device |
| 2022 | Migration or Expulsion of Device | 2 | Device |
| 2022 | Interrogation Problem | 1 | Device |
| 2022 | Insufficient Information | 1 | Device |
| 2022 | Incorrect, Inadequate or Imprecise Result or Readings | 1 | Device |
| 2022 | Incorrect Measurement | 6 | Device |
| 2022 | Inappropriate or Unexpected Reset | 1 | Device |
| 2022 | Failure to Sense | 4 | Device |
| 2022 | Failure to Interrogate | 12 | Device |
| 2022 | Device Sensing Problem | 1 | Device |
| 2022 | Detachment of Device or Device Component | 2 | Device |
| 2022 | Data Problem | 4 | Device |
| 2022 | Break | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 8 | Device |
| 2021 | Signal Artifact/Noise | 1 | Device |
| 2021 | Premature Discharge of Battery | 1 | Device |