FDA Adverse Event
Injury
Summary report: N
RESTORE RECHARGEABLE NEUROSTIMULATOR
MDR report key: 1230549
·
Received November 13, 2008
Report
- Report Number
- 3004209178-2008-07432
- Event Type
- Injury
- Date Received
- November 13, 2008
- Date of Event
- October 1, 2008
- Report Date
- October 16, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR DEVICE SYSTEM WAS EXPLANTED DUE TO SWELLING IN THE POCKET. THE PATIENT WAS AT HOME AT THE TIME OF THE REPORT. HER STATUS WAS REPORTED AS 'FAIR'. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
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 | 44 YR | Required Intervention | IMPLANTED:| LEAD: MODEL 3777| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3777 |