FDA Adverse Event
Injury
Summary report: N
RESTORE RECHARGEABLE NEUROSTIMULATOR
MDR report key: 1213281
·
Received October 27, 2008
Report
- Report Number
- 3004209178-2008-06921
- Event Type
- Injury
- Date Received
- October 27, 2008
- Date of Event
- September 1, 2008
- Report Date
- September 26, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT WAS HAVING PROBLEMS RECHARGING THEIR NEUROSTIMULATOR. THE PATIENT REPORTED COUPLING OR COMMUNICATION ISSUES. THE DEVICE WAS LATER CONFIRMED TO BE FLIPPED IN THE POCKET. THE DEVICE WAS EXPLANTED. THE PATIENT HAD PREVIOUSLY HAD TWO REVISIONS FOR SIMILAR EVENTS. SEE MFR REPORT # 3004209178-2008-06923 AND 3004209178-2008-06924.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE RECHARGEABLE NEUROSTIMULATOR | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37711 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081| LEAD: MODEL 3777 |