FDA Adverse Event
Malfunction
Summary report: N
RESTORE RECHARGABLE NEUROSTIMULATOR
MDR report key: 1960401
·
Received December 16, 2010
Report
- Report Number
- 3004209178-2010-10531
- Event Type
- Malfunction
- Date Received
- December 16, 2010
- Date of Event
- December 6, 2010
- Report Date
- December 6, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
INFO RECEIVED REPORTING PT IS NOT ABLE TO ADJUST HIS STIMULATION WITH HIS PROGRAMER OR RECHARGER. THEY ARE SHOWING A "CALL YOUR DOCTOR" ICON, POWER ON RESET CONDITION. PT HAS NOT BEEN USING HIS STIMULATION BUT KEEPS THE DEVICE RECHARGED. HE NEEDS TO USE IT NOW WITH THE COLD WEATHER AND ALL THE SNOW. ADDITIONAL INFO REQUESTED AND IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE RECHARGABLE NEUROSTIMULATOR | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37711 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | IMPLANTED:| EXTENSION: MODEL 37081, LOT # NJB003605V| PROGRAMMER: MODEL 37742, LOT # NJD022495N| LEAD: MODEL 3778, LOT # V006508| LEAD: MODEL 3778, LOT # V006606| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT # NJB003604V| EXPLANTED:| EXPLANTED: |