PERMANENT PACEMAKER ELECTRODE Adverse Event — Malfunction (MDR 2938836-2020-02846)
PERMANENT PACEMAKER ELECTRODE Adverse Event — Malfunction (MDR 2938836-2020-02846) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: PERMANENT PACEMAKER ELECTRODE; Generic name: PERMANENT PACEMAKER ELECTRODE; Manufacturer: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE).
| Device | PERMANENT PACEMAKER ELECTRODE |
|---|---|
| Generic name | PERMANENT PACEMAKER ELECTRODE |
| Manufacturer | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) |
| Report number | 2938836-2020-02846 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | OTHER |
| Narrative | NO COMPLAINT WAS RECEIVED WITH THE RETURN OF THE DEVICE. FAILURE EVENT OBSERVED DURING ANALYSIS. A PARTIAL LEAD WITH THE DISTAL TIP MEASURING 41.5 / 44.0 / 46.5 CM INNER AND OUTER INSULATIONS /OUTER COIL / INNER COIL. FINAL ANALYSIS FOUND CLAVICULAR CRUSH DAMAGE DISTAL TO THE SUTURE SLEEVE TIE IMPRESSION DAMAGING THE OUTER INSULATION. OTHER DAMAGES FOUND ARE CONSISTENT WITH PROCEDURAL DAMAGE. |
| Source | openFDA MAUDE (device adverse events) |
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