FDA Adverse Event
Malfunction
Summary report: N
RESTORE RECHARGEABLE NEUROSTIMULATOR
MDR report key: 1133593
·
Received August 20, 2008
Report
- Report Number
- 3004209178-2008-04987
- Event Type
- Malfunction
- Date Received
- August 20, 2008
- Date of Event
- July 2, 2008
- Report Date
- July 16, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EXTENSION.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT HAD DIFFICULTY RECHARGING AND PROGRAMMING THE STIMULATOR. THE PATIENT UNDERWENT BECAUSE OF MIGRATION OF THE LEFT INTERNAL PULSE GENERATOR; A BROKEN EXTENSION LEAD WIRE WAS FOUND AND REPLACED. THE PATIENT RECOVERED WITHOUT SEQUELA. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION 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 | 56 YR | Required Intervention | EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081| EXTENSION: MODEL 37081| IMPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR : MODEL 37711| EXPLANTED:| LEAD: MODEL 3777| EXPLANTED:| LEAD: MODEL 3777| IMPLANTED:| EXPLANTED:| IMPLANTED:| LOT# NJH716143H| EXPLANTED:| EXTENSION: MODEL 37082| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD MODEL 3998 |