RIATA ACTIVE FIXATION Adverse Event — Malfunction (MDR 2017865-2020-05479)
RIATA ACTIVE FIXATION Adverse Event — Malfunction (MDR 2017865-2020-05479) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: RIATA ACTIVE FIXATION; Generic name: DEFIBRILLATION LEAD; Manufacturer: ST. JUDE MEDICAL, INC.(CRM-SYLMAR).
| Device | RIATA ACTIVE FIXATION |
|---|---|
| Generic name | DEFIBRILLATION LEAD |
| Manufacturer | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
| Report number | 2017865-2020-05479 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | COMPANY REPRESENTATIVE, FOREIG |
| Narrative | 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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