RECORDER, EVENT, IMPLANTABLE CARDIAC, (WITH ARRHYTHMIA DETECTION)
This device is manufactured by MEDTRONIC, MEDTRONIC SINGAPORE OPERATIONS.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Wound Dehiscence | 2 | Patient |
| 2024 | Unspecified Infection | 7 | Patient |
| 2024 | Swelling/ Edema | 3 | Patient |
| 2024 | Purulent Discharge | 3 | Patient |
| 2024 | Pain | 5 | Patient |
| 2024 | Itching Sensation | 1 | Patient |
| 2024 | Inflammation | 1 | Patient |
| 2024 | Hypersensitivity/Allergic reaction | 1 | Patient |
| 2024 | Hematoma | 1 | Patient |
| 2024 | Fluid Discharge | 1 | Patient |
| 2024 | Erythema | 5 | Patient |
| 2024 | Erosion | 5 | Patient |
| 2024 | Dyspnea | 1 | Patient |
| 2024 | Discomfort | 5 | Patient |
| 2024 | Chest Pain | 1 | Patient |
| 2024 | Cellulitis | 1 | Patient |
| 2024 | Burning Sensation | 1 | Patient |
| 2024 | Bruise/Contusion | 1 | Patient |
| 2024 | Angina | 1 | Patient |
| 2024 | Under-Sensing | 34 | Device |
| 2024 | Unable to Obtain Readings | 4 | Device |
| 2024 | Signal Artifact/Noise | 71 | Device |
| 2024 | Reset Problem | 89 | Device |
| 2024 | Premature Discharge of Battery | 12 | Device |
| 2024 | Over-Sensing | 55 | Device |
| 2024 | Output Problem | 34 | Device |
| 2024 | Migration or Expulsion of Device | 11 | Device |
| 2024 | Mechanical Problem | 1 | Device |
| 2024 | Manufacturing, Packaging or Shipping Problem | 1 | Device |
| 2024 | Inappropriate or Unexpected Reset | 38 | Device |
| 2024 | Electromagnetic Interference | 10 | Device |
| 2024 | Device Sensing Problem | 17 | Device |
| 2024 | Device Markings/Labelling Problem | 1 | Device |
| 2024 | Decreased Sensitivity | 4 | Device |
| 2024 | Data Problem | 14 | Device |
| 2024 | Communication or Transmission Problem | 6 | Device |
| 2024 | Battery Problem | 1 | Device |
| 2024 | Appropriate Term/Code Not Available | 2 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 9 | Device |
| 2023 | Wound Dehiscence | 1 | Patient |
| 2023 | Unspecified Infection | 12 | Patient |
| 2023 | Swelling/ Edema | 2 | Patient |
| 2023 | Purulent Discharge | 4 | Patient |
| 2023 | Pulmonary Embolism | 1 | Patient |
| 2023 | Pocket Erosion | 1 | Patient |
| 2023 | Pain | 7 | Patient |
| 2023 | Itching Sensation | 2 | Patient |
| 2023 | Inflammation | 1 | Patient |
| 2023 | Impaired Healing | 1 | Patient |
| 2023 | Hypersensitivity/Allergic reaction | 1 | Patient |
| 2023 | Hematoma | 2 | Patient |
| 2023 | Fever | 1 | Patient |
| 2023 | Failure of Implant | 1 | Patient |
| 2023 | Erythema | 2 | Patient |
| 2023 | Erosion | 5 | Patient |
| 2023 | Discomfort | 6 | Patient |
| 2023 | Under-Sensing | 58 | Device |
| 2023 | Unable to Obtain Readings | 13 | Device |
| 2023 | Signal Artifact/Noise | 59 | Device |
| 2023 | Reset Problem | 89 | Device |
| 2023 | Premature Discharge of Battery | 11 | Device |
| 2023 | Packaging Problem | 1 | Device |
| 2023 | Over-Sensing | 58 | Device |
| 2023 | Output Problem | 108 | Device |
| 2023 | Migration or Expulsion of Device | 21 | Device |
| 2023 | Mechanical Problem | 2 | Device |
| 2023 | Loss of Data | 3 | Device |
| 2023 | Incorrect Measurement | 1 | Device |
| 2023 | Inappropriate or Unexpected Reset | 71 | Device |
| 2023 | Failure to Interrogate | 3 | Device |
| 2023 | Electromagnetic Interference | 13 | Device |
| 2023 | Device-Device Incompatibility | 2 | Device |
| 2023 | Device Sensing Problem | 39 | Device |
| 2023 | Decreased Sensitivity | 9 | Device |
| 2023 | Data Problem | 22 | Device |
| 2023 | Communication or Transmission Problem | 16 | Device |
| 2023 | Appropriate Term/Code Not Available | 5 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 12 | Device |
| 2022 | Unspecified Infection | 2 | Patient |
| 2022 | Purulent Discharge | 1 | Patient |
| 2022 | Erythema | 1 | Patient |
| 2022 | Under-Sensing | 19 | Device |
| 2022 | Unable to Obtain Readings | 2 | Device |
| 2022 | Signal Artifact/Noise | 9 | Device |
| 2022 | Reset Problem | 34 | Device |
| 2022 | Positioning Problem | 1 | Device |
| 2022 | Over-Sensing | 13 | Device |
| 2022 | Output Problem | 65 | Device |
| 2022 | Migration or Expulsion of Device | 10 | Device |
| 2022 | Mechanical Problem | 31 | Device |
| 2022 | Loss of Data | 1 | Device |
| 2022 | Incorrect Measurement | 1 | Device |
| 2022 | Inappropriate or Unexpected Reset | 24 | Device |
| 2022 | Failure to Interrogate | 1 | Device |
| 2022 | Electromagnetic Interference | 3 | Device |
| 2022 | Device-Device Incompatibility | 1 | Device |
| 2022 | Device Sensing Problem | 22 | Device |
| 2022 | Decreased Sensitivity | 1 | Device |
| 2022 | Data Problem | 3 | Device |
| 2022 | Communication or Transmission Problem | 6 | Device |
| 2022 | Battery Problem | 2 | Device |
| 2022 | Appropriate Term/Code Not Available | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 4 | Device |
| 2021 | Signal Artifact/Noise | 3 | Device |
| 2021 | Reset Problem | 6 | Device |
| 2021 | Over-Sensing | 1 | Device |
| 2021 | Output Problem | 11 | Device |
| 2021 | Mechanical Problem | 13 | Device |
| 2021 | Inappropriate or Unexpected Reset | 2 | Device |
| 2021 | Data Problem | 2 | Device |