FDA Adverse Event
Malfunction
Summary report: N
RESTORE RECHARGEABLE NEUROSTIMULATOR
MDR report key: 2181582
·
Received July 7, 2011
Report
- Report Number
- 3004209178-2011-05191
- Event Type
- Malfunction
- Date Received
- July 7, 2011
- Date of Event
- January 1, 2011
- Report Date
- June 14, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WERE COUPLING AND/OR COMMUNICATION ISSUES. IT WAS REVIEWED HOW TO ADJUST THE ANTENNA DIAL. RECOMMENDED X-RAY TO DETERMINE IF INS WAS FLIPPED. THE HCP FLIPPED THE INS OVER IN THE OFFICE AND THE PATIENT WAS 'PERFECT' NOW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE RECHARGEABLE NEUROSTIMULATOR | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37711 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | EXPLANTED:| LEAD: MODEL 39565-65, LOT# V446253047| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA152477N |