FORTIFY DR, U1.6 SJ4 US Adverse Event — Malfunction (MDR 2017865-2020-05465)
FORTIFY DR, U1.6 SJ4 US Adverse Event — Malfunction (MDR 2017865-2020-05465) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: FORTIFY DR, U1.6 SJ4 US; Generic name: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR; Manufacturer: ST. JUDE MEDICAL, INC.(CRM-SYLMAR).
| Device | FORTIFY DR, U1.6 SJ4 US |
|---|---|
| Generic name | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |
| Manufacturer | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
| Report number | 2017865-2020-05465 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-27 |
| Report source | COMPANY REPRESENTATIVE, HEALTH |
| 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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