DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR Adverse Event — Malfunction (MDR 2017865-2020-05509)
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR Adverse Event — Malfunction (MDR 2017865-2020-05509) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; Generic name: DEFIBRILLATION LEAD; Manufacturer: ST. JUDE MEDICAL, INC.(CRM-SYL
| Device | DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR |
|---|---|
| Generic name | DEFIBRILLATION LEAD |
| Manufacturer | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
| Report number | 2017865-2020-05509 |
| 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, AS RECEIVED, A COMPLETE LEAD. THE LEAD WAS RECEIVED IN TWO PIECES, CONNECTOR PORTION MEASURED 13.5 CM WHILE THE DISTAL PORTION MEASURED 44.0 CM. ONE EXTERNAL INSULATION ABRASION WAS NOTED BREACHING THE OPTIM SHEATH ONLY AT 10.4- |
| Source | openFDA MAUDE (device adverse events) |
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