FDA Adverse Event
Injury
Summary report: N
RESTORE RECHARGABLE NEUROSTIMULATOR
MDR report key: 1162795
·
Received September 16, 2008
Report
- Report Number
- 3004209178-2008-05799
- Event Type
- Injury
- Date Received
- September 16, 2008
- Date of Event
- August 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
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE HCP REPORTED THAT THE IMPLANTABLE NEUROSTIMULATION SYSTEM WAS EXPLANTED DUE TO INFECTION. PATIENT SYMPTOMS INCLUDED DRAINAGE AT THE INCISION MADE FOR THE CONNECTOR OF THE BIFURCATED EXTENSION. THE PATIENT REQUESTED NOT TO BE REIMPLANTED. THE HCP REPORTED THE PATIENT OUTCOME AS 'RECOVERED WITHOUT SEQUELA'.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE RECHARGABLE NEUROSTIMULATOR | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37711 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXTENSION MODEL 37082 LOT# NKB000985N IMPLANTED| EXTENSION MODEL 37082 LOT# NKB000984N IMPLANTED| LEAD MODEL 3487A LOT# V098886 IMPLANTED| PROGRAMMER MODEL 37742 LOT# NJD024203N| EXPLANTED| EXPLANTED| EXPLANTED |