FDA Adverse Event
Malfunction
Summary report: N
RESTORE RECHARGABLE NEUROSTIMULATOR
MDR report key: 1213781
·
Received October 22, 2008
Report
- Report Number
- 3004209178-2008-06739
- Event Type
- Malfunction
- Date Received
- October 22, 2008
- Report Date
- September 24, 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
- US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PT SLIPPED AND FELL. SINCE THAT TIME SHE HAD SOME ISSUES WITH NOT FEELING STIMULATION IN THE SAME AREA AND THE STIMULATION WAS WEAK COMPARED TO WHAT IT USED TO BE. X-RAYS (DATE NOT REPORTED) DID NOT INDICATE LEAD MIGRATION. IMPEDANCES DID NOT SUGGEST AN OPEN CIRCUIT. THE STIMULATOR WAS REPROGRAMMED WITH NO SUCCESS. ADD'L INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADD'L 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 | EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD MODEL 377745| EXPLANTED:| LEAD: MODEL 377745| IMPLANTED:| EXTENSION: MODEL 37081| PROGRAMMER: MODEL 37742| EXTENSION: MODEL 37081| IMPLANTED:| EXPLANTED: |