DETECTOR AND ALARM, ARRHYTHMIA
This device is manufactured by MEDTRONIC, MEDTRONIC EP SYSTEMS, MEDTRONIC EUROPE SARL, MEDTRONIC MED REL MEDTRONIC PUERTO RICO, MEDTRONIC PUERTO RICO OPERATIONS CO and others.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Infection | 5 | Patient |
| 2024 | Swelling/ Edema | 1 | Patient |
| 2024 | Purulent Discharge | 1 | Patient |
| 2024 | Pain | 2 | Patient |
| 2024 | Itching Sensation | 1 | Patient |
| 2024 | Erythema | 2 | Patient |
| 2024 | Erosion | 2 | Patient |
| 2024 | Discomfort | 3 | Patient |
| 2024 | Appropriate Term / Code Not Available | 1 | Patient |
| 2024 | Under-Sensing | 16 | Device |
| 2024 | Unable to Obtain Readings | 4 | Device |
| 2024 | Signal Artifact/Noise | 12 | Device |
| 2024 | Reset Problem | 4 | Device |
| 2024 | Over-Sensing | 15 | Device |
| 2024 | Migration or Expulsion of Device | 5 | Device |
| 2024 | Failure to Interrogate | 1 | Device |
| 2024 | Electromagnetic Interference | 5 | Device |
| 2024 | Device-Device Incompatibility | 1 | Device |
| 2024 | Device Sensing Problem | 6 | Device |
| 2024 | Communication or Transmission Problem | 20 | Device |
| 2024 | Battery Problem | 4 | Device |
| 2024 | Appropriate Term/Code Not Available | 4 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 5 | Device |
| 2023 | Unspecified Infection | 5 | Patient |
| 2023 | Swelling/ Edema | 1 | Patient |
| 2023 | Pain | 6 | Patient |
| 2023 | Local Reaction | 1 | Patient |
| 2023 | Erythema | 1 | Patient |
| 2023 | Erosion | 3 | Patient |
| 2023 | Discomfort | 1 | Patient |
| 2023 | Burning Sensation | 1 | Patient |
| 2023 | Blister | 1 | Patient |
| 2023 | Under-Sensing | 36 | Device |
| 2023 | Unable to Obtain Readings | 9 | Device |
| 2023 | Signal Artifact/Noise | 14 | Device |
| 2023 | Reset Problem | 8 | Device |
| 2023 | Premature Discharge of Battery | 1 | Device |
| 2023 | Packaging Problem | 1 | Device |
| 2023 | Over-Sensing | 28 | Device |
| 2023 | Output Problem | 1 | Device |
| 2023 | Migration or Expulsion of Device | 12 | Device |
| 2023 | Incorrect Measurement | 1 | Device |
| 2023 | Human-Device Interface Problem | 1 | Device |
| 2023 | Failure to Interrogate | 6 | Device |
| 2023 | Electromagnetic Interference | 4 | Device |
| 2023 | Display or Visual Feedback Problem | 1 | Device |
| 2023 | Device-Device Incompatibility | 1 | Device |
| 2023 | Device Sensing Problem | 12 | Device |
| 2023 | Decreased Sensitivity | 1 | Device |
| 2023 | Communication or Transmission Problem | 26 | Device |
| 2023 | Battery Problem | 4 | Device |
| 2023 | Appropriate Term/Code Not Available | 3 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 7 | Device |
| 2022 | Unspecified Infection | 1 | Patient |
| 2022 | Pain | 1 | Patient |
| 2022 | Erosion | 1 | Patient |
| 2022 | Cancer | 1 | Patient |
| 2022 | Bacterial Infection | 1 | Patient |
| 2022 | Under-Sensing | 35 | Device |
| 2022 | Unable to Obtain Readings | 8 | Device |
| 2022 | Signal Artifact/Noise | 7 | Device |
| 2022 | Reset Problem | 6 | Device |
| 2022 | Premature Discharge of Battery | 1 | Device |
| 2022 | Over-Sensing | 26 | Device |
| 2022 | Output Problem | 1 | Device |
| 2022 | Migration or Expulsion of Device | 9 | Device |
| 2022 | Failure to Interrogate | 7 | Device |
| 2022 | Electromagnetic Interference | 5 | Device |
| 2022 | Device-Device Incompatibility | 4 | Device |
| 2022 | Device Sensing Problem | 8 | Device |
| 2022 | Decreased Sensitivity | 1 | Device |
| 2022 | Data Problem | 1 | Device |
| 2022 | Communication or Transmission Problem | 13 | Device |
| 2022 | Battery Problem | 3 | Device |
| 2022 | Appropriate Term/Code Not Available | 6 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 9 | Device |
| 2021 | Insufficient Information | 1 | Patient |
| 2021 | Under-Sensing | 29 | Device |
| 2021 | Signal Artifact/Noise | 4 | Device |
| 2021 | Over-Sensing | 25 | Device |
| 2021 | Insufficient Information | 1 | Device |
| 2021 | Device Sensing Problem | 4 | Device |
| 2021 | Decreased Sensitivity | 1 | Device |
| 2021 | Appropriate Term/Code Not Available | 2 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2020 | Pain | 1 | Patient |
| 2020 | Under-Sensing | 11 | Device |
| 2020 | Over-Sensing | 8 | Device |
| 2020 | Device Sensing Problem | 1 | Device |
| 2020 | Battery Problem | 1 | Device |
| 2020 | Appropriate Term/Code Not Available | 1 | Device |