RESTORE ADVANCED RECHARGEABLE Adverse Event — Injury (MDR 3004209178-2008-00714)
RESTORE ADVANCED RECHARGEABLE Adverse Event — Injury (MDR 3004209178-2008-00714) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: RESTORE ADVANCED RECHARGEABLE; Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.; Report number: 3004209178-2008-00714.
| Device | RESTORE ADVANCED RECHARGEABLE |
|---|---|
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO. |
| Report number | 3004209178-2008-00714 |
| Event type | Injury |
| Product problem | N |
| Date received | 2008-02-15 |
| Report source | Company representation |
| Narrative | THE MANUFACTURER REPRESENTATIVE REPORTED, AN INFECTION AT THE DEVICE POCKET. THE NEUROSTIMULATOR WAS REMOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BY MEDTRONIC FROM THE HEALTH CARE PROFESSIONAL REGARDING THE REPORTED EVENT. A SUPPLEMENTAL MDR FOLLOW-UP REPORT WILL BE SENT TO THE FDA IF ADDITIONAL INFORMATION IS RECEIVED. |
| Source | openFDA MAUDE (device adverse events) |
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