FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 1934186
·
Received December 8, 2010
Report
- Report Number
- 3004209178-2010-10315
- Event Type
- Malfunction
- Date Received
- December 8, 2010
- Date of Event
- October 1, 2010
- Report Date
- November 28, 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
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
RECEIVED REPORT THAT THE PT IS FEELING STIMULATION IN THE WRONG LOCATION, BOTH PROGRAMS ARE NOT COVERING THE AREAS THAT THEY USED TO COVER. PT WAS IN A MINOR CAR ACCIDENT ABOUT A MONTH AGO AND IS RECEIVING PHYSICIAN THERAPY, MOSTLY HOT PACKS. ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF INFO BECOMES AVAILABLE, A FOLLOW UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ULTRA | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37712 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | ACCESSORY: MODEL 37752, LOT# NKA110285N| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB023560V| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE105667N| EXPLANTED:| LEAD: MODEL 39286-65, LOT# N211343003| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3776, LOT# V058484005| EXTENSION: MODEL 37081, LOT# NJB041147V| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB021440V| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB053604V| EXPLANTED:| IMPLANTED: |