ACCENT DR RF PACEMAKER Adverse Event — Malfunction (MDR 2938836-2020-02891)
ACCENT DR RF PACEMAKER Adverse Event — Malfunction (MDR 2938836-2020-02891) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: ACCENT DR RF PACEMAKER; Generic name: IMPLANTABLE PACEMAKER PULSE GENERATOR; Manufacturer: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE).
| Device | ACCENT DR RF PACEMAKER |
|---|---|
| Generic name | IMPLANTABLE PACEMAKER PULSE GENERATOR |
| Manufacturer | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) |
| Report number | 2938836-2020-02891 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2020-04-28 |
| Report source | HEALTH PROFESSIONAL, USER FACI |
| 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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