PERMANENT PACEMAKER ELECTRODE Adverse Event — Malfunction (MDR 2017865-2020-05443)
PERMANENT PACEMAKER ELECTRODE Adverse Event — Malfunction (MDR 2017865-2020-05443) 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-SYLMAR).
| Device | PERMANENT PACEMAKER ELECTRODE |
|---|---|
| Generic name | PERMANENT PACEMAKER ELECTRODE |
| Manufacturer | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
| Report number | 2017865-2020-05443 |
| 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. A FAILURE EVENT WAS OBSERVED DURING ANALYSIS. ONLY A DISTAL PORTION OF THE LEAD WAS RETURNED IN ONE PIECE MEASURING 40.6CM FOR ANALYSIS. VISUAL INSPECTION FOUND THE CLAVICLE CRUSH IN THE MIDDLE REGION OF THE LEAD AT 21.0CM TO 21.7CM FROM THE DISTAL TIP. X-RAY FOUND THE OUTER COIL WAS FRACT |
| Source | openFDA MAUDE (device adverse events) |
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