DURATA STS OPTIM ACTIVE FIXATION Adverse Event — Injury (MDR 2938836-2020-02876)
DURATA STS OPTIM ACTIVE FIXATION Adverse Event — Injury (MDR 2938836-2020-02876) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: DURATA STS OPTIM ACTIVE FIXATION; Generic name: DEFIBRILLATION LEAD; Manufacturer: ABBOTT.
| Device | DURATA STS OPTIM ACTIVE FIXATION |
|---|---|
| Generic name | DEFIBRILLATION LEAD |
| Manufacturer | ABBOTT |
| Report number | 2938836-2020-02876 |
| Event type | Injury |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| 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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