FDA Adverse Event
Injury
Summary report: N
RESTORE RECHARGEABLE NEUROSTIMULATOR
MDR report key: 1080743
·
Received July 23, 2008
Report
- Report Number
- 3004209178-2008-04207
- Event Type
- Injury
- Date Received
- July 23, 2008
- Date of Event
- January 1, 2008
- Report Date
- June 23, 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
- IN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED A BURNING SENSATION, AS WELL AS A NO STIMULATION WITH OCCASIONAL EFFECTIVE SHOCKS. IT WAS CONFIRMED THAT THE PT'S LEAD WAS BROKEN. THE PT THEN DEVELOPED CELLULITIS WHICH DELAYED THE REVISION SURGERY (RELATIONSHIP TO THE DEVICE THERAPY WAS NOT REPORTED). THE PT LATER UNDERWENT REVISION SURGERY TO PLACE A SECOND LEAD. THE PT OUTCOME WAS REPORTED AS NON-SERIOUS INJURY/ILLNESS.
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 | 42 YR | Required Intervention | ACCESSORY MODEL 37752 LOT# NKA033183N| LEAD MODEL 3777 LOT# V021353| EXPLANTED| IMPLANTED |