TENDRIL SDX LEAD Adverse Event — Malfunction (MDR 2938836-2020-02882)
TENDRIL SDX LEAD Adverse Event — Malfunction (MDR 2938836-2020-02882) 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-SUNNYVALE).
| Device | TENDRIL SDX LEAD |
|---|---|
| Generic name | PERMANENT PACEMAKER ELECTRODE |
| Manufacturer | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) |
| Report number | 2938836-2020-02882 |
| 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 EXTERNAL INSULATION ABRASION BREACHING THE OUTER INSULATION NOTED AT 6.4-8.3 CM FROM THE DISTAL TIP CONSISTENT WITH LEAD FRICTION TO ANOTHER DEVICE OR FEATURE OF THE HEART. |
| Source | openFDA MAUDE (device adverse events) |
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