FDA Adverse Event
Injury
Summary report: N
RESTORE PRIME
MDR report key: 1150390
·
Received September 5, 2008
Report
- Report Number
- 3004209178-2008-05472
- Event Type
- Injury
- Date Received
- September 5, 2008
- Date of Event
- January 1, 2008
- Report Date
- August 7, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IMPLANTABLE NEUROSTIMULATOR WAS EXPLANTED DUE TO AN EROSION AND INFECTION. ADDITIONAL INFORMATION HAD 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 PRIME | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37701 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED| LEAD MODEL 3778 LOT# V047396022| IMPLANTED| EXPLANTED| LEAD MODEL 3778 LOT# V047396023| PROGRAMMER MODEL 37742 LOT# NJD049142N| IMPLANTED |