FDA Adverse Event
Malfunction
Summary report: N
RESTORE RECHARGEABLE NEUROSTIMULATOR
MDR report key: 1761268
·
Received July 15, 2010
Report
- Report Number
- 3004209178-2010-05514
- Event Type
- Malfunction
- Date Received
- July 15, 2010
- Date of Event
- January 1, 2010
- Report Date
- June 23, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO, JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT STILL HAD PAIN IN THE UPPER BACK AND COULD "BARELY MOVE" AFTER REPROGRAMMING IN LATE (B)(6)2009. THE PT HAD MET WITH THE COMPANY REP 3 TIMES SINCE THIS EVENT. IT WAS NOTED THAT THE PAIN IN THE BACK AND NECK WAS NOT DUE TO DEVICE. HOWEVER, DURING AN IMPEDANCE CHECK, A NUMBER OF ELECTRODES WERE "DEAD". THE REP WAS GOING TO CONTACT THE PT'S PHYSICIAN TO DETERMINE THE NEXT STEPS.
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 | 44 YR | IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB001328N| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3778, LOT# N0049325| ACCESSORY: MODEL 37752, LOT# NKA011652N| EXPLANTED:| LEAD: MODEL 3778, LOT# N0049325| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB001609N| PROGRAMMER: MODEL 37742, LOT# NJD010711N| EXPLANTED:| IMPLANTED: |