FDA Adverse Event
Malfunction
Summary report: N
RESTORE RECHARGEABLE NEUROSTIMULATOR
MDR report key: 1200052
·
Received October 15, 2008
Report
- Report Number
- 3004209178-2008-06568
- Event Type
- Malfunction
- Date Received
- October 15, 2008
- Report Date
- September 15, 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
- LA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
IT WAS REPORTED, WHILE THE PATIENT'S STIMULATOR IS TURNED ON THE PT EXPERIENCES SHOCKING/JOLTING. THE SYMPTOMS BEGAN ABOUT A YEAR AGO. THERE WAS NO KNOWN EVENT ASSOCIATED WITH THE START OF THESE SYMPTOMS. THE SHOCKING OCCURS AT THE INS POCKET. THE PT REMAINED AT HOME. THE PATIENT'S STATUS WAS GOOD. THE PT HAD UNDERGONE REPROGRAMMING OF THE DEVICE WHICH DID NOT HELP (DATE OF REPROGRAMMING UNK). ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE ON THE DATE OF THIS REPORT.
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 | PROGRAMMER: MODEL 37742| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37083| LEAD: MODEL 3888 |