FDA Adverse Event
Malfunction
Summary report: N
RESTORE
MDR report key: 1062281
·
Received June 18, 2008
Report
- Report Number
- 2182207-2008-03348
- Event Type
- Malfunction
- Date Received
- June 18, 2008
- Date of Event
- May 1, 2008
- Report Date
- May 22, 2008
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT WAS INJURED ON THE SAME SIDE AS THE NEUROSTIMULATOR DURING A CAR ACCIDENT. THE DEVICE DISCHARGED; THE PATIENT RECEIVED NO STIMULATION. A PHYSICIAN MODE RECHARGE (PMR) WAS PERFORMED BY THE PATIENT. TWO DAYS LATER THE BATTERY WAS DEPLETED AGAIN. A POWER ON RESET (POR) CONDITION OCCURRED. THE PATIENT WAS INSTRUCTED TO RECHARGE THE DEVICE UNTIL THE DEVICE WAS AT LEAST 25% CHARGED BEFORE INTERROGATING THE DEVICE. THE PATIENT CONTINUES TO HAVE DIFFICULTY RECHARGING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE | LGW | MEDTRONIC NEUROMODULATION | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |