OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR Adverse Event — Malfunction (MDR 2017865-2020-05455)
OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR Adverse Event — Malfunction (MDR 2017865-2020-05455) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR; Generic name: DEFIBRILLATION LEAD; Manufacturer: ST. JUDE MEDICAL, INC.(CRM-SYLMAR).
| Device | OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR |
|---|---|
| Generic name | DEFIBRILLATION LEAD |
| Manufacturer | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
| Report number | 2017865-2020-05455 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| Narrative | THIS PRODUCT IS REGISTERED AS A COMBINATION PRODUCT. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. |
| Source | openFDA MAUDE (device adverse events) |
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