FDA Adverse Event
Malfunction
Summary report: N
RESTORE RECHARGABLE NEUROSTIMULATOR
MDR report key: 1170714
·
Received September 16, 2008
Report
- Report Number
- 3004209178-2008-05819
- Event Type
- Malfunction
- Date Received
- September 16, 2008
- Date of Event
- August 20, 2008
- Report Date
- August 20, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PT FELL ABOUT 2 WEEKS AGO AND LOST STIMULATION SENSATION. THE IMPLANTABLE NEUROSTIMULATOR WAS UNABLE TO COMMUNICATE WITH THE RECHARGER OR PATIENT AND PHYSICIAN PROGRAMMER. THE NEUROSTIMULATOR BATTERY HAD OVERDISCHARGED AND THE DEVICE WAS IN A POWER ON RESET CONDITION. AN X-RAY WAS TAKEN (RESULTS NOT REPORTED). ADDITIONAL INFO HAS BEEN REQUESTED. 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 RECHARGABLE NEUROSTIMULATOR | LGW | MEDTRONIC PUERTO RICO OPERATIONS CO | 37711 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 43 YR | EXPLANTED| EXPLANTED| LEAD: MODEL 3778| EXPLANTED| LEAD: MODEL 3778| PROGRAMMER: MODEL 37742 |