FDA Adverse Event
Malfunction
Summary report: N
RESTORE RECHARGEABLE NEUROSTIMULATOR
MDR report key: 1061477
·
Received June 13, 2008
Report
- Report Number
- 3004209178-2008-03225
- Event Type
- Malfunction
- Date Received
- June 13, 2008
- Date of Event
- January 1, 2007
- Report Date
- May 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
- IN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THE PT EXPERIENCED SHOCKING SENSATIONS AND STIMULATION "EVERYWHERE BUT IN THE RIGHT PLACE". THE PT HAD BEEN TAKING ORAL PAIN MEDICATION. THE ENTIRE SYSTEM WAS REPLACED. NO OUTCOME WAS REPORTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFO BECOMES AVAILABLE.
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 | IMPLANTED| EXPLANTED| LEAD MODEL 3890| EXTENSION MODEL 37083| EXPLANTED| IMPLANTED| PROGRAMMER MODEL 37742| EXPLANTED |