FDA Adverse Event
Malfunction
Summary report: N
RESTORE RECHARGEABLE NEUROSTIMULATOR
MDR report key: 1913535
·
Received November 12, 2010
Report
- Report Number
- 3004209178-2010-09406
- Event Type
- Malfunction
- Date Received
- November 12, 2010
- Date of Event
- October 28, 2010
- Report Date
- October 28, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE STIMULATION COULD NOT BE ADJUSTED WITH THE PT PROGRAMMER. THE PT HAD EXPERIENCED TRAUMA TO THE BODY, BUT NO SPECIFICS WERE REPORTED. THE PT COULD FEEL STIMULATION IN ONE LEG. THERE WAS ALSO A PROBLEM WITH THE RECHARGER. THE RECHARGER HAD NO SHADED COUPLING BOXES, AND THEN THE SCREEN CHANGED TO THE "POOR COMMUNICATION" SCREEN. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
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 | 50 YR | EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| PROGRAMMER: MODEL 37742, LOT # NJD045000N| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37083, LOT # NKC006562N| IMPLANTED:| EXTENSION: MODEL 37083, LOT # NKC006563N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3998, LOT # J0546281V| ACCESSORY: MODEL 37752, LOT # NKA016718N| IMPLANTED: |