FDA Adverse Event
Injury
Summary report: N
RESTORE ULTRA
MDR report key: 1162107
·
Received September 16, 2008
Report
- Report Number
- 3004209178-2008-05802
- Event Type
- Injury
- Date Received
- September 16, 2008
- Date of Event
- July 1, 2008
- Report Date
- August 20, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S LEAD ERODED ABOUT 2 INCHES OUT OF HER BODY. IT WAS ALSO REPORTED THAT THE PT HAD AN INFECTION AT BOTH THE STIMULATOR AND THE LEAD LOCATION. THE SYSTEM WAS EXPLANTED. THE PTS STATUS WAS REPORTED AS GOOD APPROX ONE MONTH POST-EXPLANT. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ULTRA | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37712 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention | EXPLANTED| EXTENSION MODEL 37081 LOT# NJB035967V IMPLANTED| EXTENSION MODEL 37081 LOT# NJB035966V IMPLANTED| PROGRAMMER MODEL 37743 LOT# NKE102840N| ACCESSORY MODEL 37752 LOT# NKA111448N| EXPLANTED |