FDA Adverse Event
Injury
Summary report: N
RESTORE RECHARGABLE NEUROSTIMULATOR
MDR report key: 1971589
·
Received January 25, 2011
Report
- Report Number
- 3004209178-2011-00607
- Event Type
- Injury
- Date Received
- January 25, 2011
- Date of Event
- December 2, 2009
- Report Date
- January 11, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PT FELT DISCOMFORT AT THE SITE OF THE IMPLANTABLE NEUROSTIMULATOR. IT WAS NOT USED. THE DEVICE DID NOT WORK FOR THE PT'S PAIN. SHE WAS VERY DEPRESSED. THE DEVICE SYS WAS EXPLANTED. THE PT RECOVERED WITHOUT SEQUELA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE RECHARGABLE NEUROSTIMULATOR | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37711 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention | EXPLANTED:| LEAD: MODEL 3777, LOT# V008486| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD025286N| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA018427N| EXPLANTED:| LEAD: MODEL 3777, LOT# V008486| EXPLANTED: |