TENDRIL ST Adverse Event — Malfunction (MDR 2017865-2020-05512)
TENDRIL ST Adverse Event — Malfunction (MDR 2017865-2020-05512) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: TENDRIL ST; Generic name: PERMANENT PACEMAKER ELECTRODE; Manufacturer: ST. JUDE MEDICAL, INC.(CRM-SYLMAR).
| Device | TENDRIL ST |
|---|---|
| Generic name | PERMANENT PACEMAKER ELECTRODE |
| Manufacturer | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
| Report number | 2017865-2020-05512 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | OTHER |
| Narrative | THIS PRODUCT IS REGISTERED AS A COMBINATION PRODUCT. NO COMPLAINT WAS RECEIVED WITH THE RETURN OF THE DEVICE. FAILURE EVENT OBSERVED DURING ANALYSIS. FINAL ANALYSIS FOUND THAT ONLY THE CONNECTOR PORTION WAS RETURNED IN ONE PIECE MEASURING 5.6 CM. VISUAL EXAMINATION FOUND A FULL BREACH INSULATION DEGRADATION ADJACENT TO THE CONNECTOR BOOT AT 4.5 CM FROM THE CONNECTOR PIN. ELECTRICAL TESTING DID NOT |
| Source | openFDA MAUDE (device adverse events) |
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