FDA Adverse Event
Injury
Summary report: N
RESTORE RECHARGEABLE NEUROSTIMULATOR
MDR report key: 1082473
·
Received July 25, 2008
Report
- Report Number
- 3004209178-2008-04422
- Event Type
- Injury
- Date Received
- July 25, 2008
- Date of Event
- September 1, 2007
- Report Date
- June 27, 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
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
THE PT WAS NOT GETTING GOOD STIMULATION. HIGH IMPEDANCE WAS NOTED AND THE LEADS WERE NOT FUNCTIONING. THE PT UNDERWENT SURGERY TO REPLACE THE LEADS, AND ALSO HAD THE STIMULATION MOVED FROM THE RIGHT FLANK AREA TO THE LEFT POSTERIOR BUTTOCK AREA IN ORDER TO TRY AND PREVENT FUTURE LEAD FRACTURES. THE PT WAS SEEN BY THE HCP 12 DAYS LATER, AND THE INCISION HAD HEALED WELL. THE PT RECOVERED WITHOUT SEQUELA.
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 | EXPLANTED| LEAD MODEL 3891| EXPLANTED| EXTENSION MODEL 37082| LEAD MODEL 3891| EXPLANTED| PROGRAMMER MODEL 37742| ACCESSORY MODEL 37752 |