FDA Adverse Event
Malfunction
Summary report: N
RESTORE RECHARGEABLE NEUROSTIMULATOR
MDR report key: 1111641
·
Received August 13, 2008
Report
- Report Number
- 3004209178-2008-04921
- Event Type
- Malfunction
- Date Received
- August 13, 2008
- Date of Event
- January 1, 2008
- Report Date
- July 16, 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
- MD, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE LEFT LEAD MIGRATED. THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. WHEN THE LEAD WAS POSITIONED CORRECTLY, THE PT REC'D SUCCESSFUL STIMULATION AND RELIEF. AT THE TIME OF THE REPORT, THE PT WAS AT HOME IN FAIR CONDITION. ADDITIONAL INFO HAS BEEN REQUESTED FROM THE HCP, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
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 | LEAD MODEL 3777| EXPLANTED| RECHARGER SYSTEM MODEL 37752| PROGRAMMER MODEL 37742| EXTENSION MODEL 37081| EXPLANTED| LEAD MODEL 3777| EXPLANTED| EXPLANTED| EXTENSION MODEL 37081 |