TENDRIL STS Adverse Event — Malfunction (MDR 2017865-2020-05462)
TENDRIL STS Adverse Event — Malfunction (MDR 2017865-2020-05462) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: TENDRIL STS; Generic name: PERMANENT PACEMAKER ELECTRODE; Manufacturer: ABBOTT.
| Device | TENDRIL STS |
|---|---|
| Generic name | PERMANENT PACEMAKER ELECTRODE |
| Manufacturer | ABBOTT |
| Report number | 2017865-2020-05462 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | THE REPORTED EVENT OF OVERSENSING WAS CONFIRMED. AS RECEIVED, ONLY THE DISTAL PORTION OF THE LEAD WAS RETURNED IN ONE PIECE. THE VISUAL EXAMINATION FOUND ONE EXTERNAL INSULATION ABRASION BREACHING THE OUTER INSULATION AND EXPOSING THE OUTER COIL CONSISTENT WITH FRICTION TO THE DEVICE CAN. THE CAUSE OF THE REPORTED EVENTS WAS ISOLATED TO THE EXTERNAL INSULATION ABRASION. THE ELECTRICAL TESTING DID |
| Source | openFDA MAUDE (device adverse events) |
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