TENDRIL SDX LEAD Adverse Event — Malfunction (MDR 2017865-2020-05423)
TENDRIL SDX LEAD Adverse Event — Malfunction (MDR 2017865-2020-05423) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: TENDRIL SDX LEAD; Generic name: PERMANENT PACEMAKER ELECTRODE; Manufacturer: ST. JUDE MEDICAL, INC.(CRM-SYLMAR).
| Device | TENDRIL SDX LEAD |
|---|---|
| Generic name | PERMANENT PACEMAKER ELECTRODE |
| Manufacturer | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
| Report number | 2017865-2020-05423 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| 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 EXTERNAL INSULATION ABRASION WAS NOTED AT 8.2 ¿ 8.7, 14.3 ¿ 14.4 AND 15.1 - 15.6 CM FROM THE CONNECTOR PIN CONSISTENT WITH LEAD FRICTION TO THE ICD CAN. THE ETFE COATING WAS INTACT AT THESE LOCATIONS. |
| Source | openFDA MAUDE (device adverse events) |
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