FDA Adverse Event
Malfunction
Summary report: N
RESTORE RECHARGEABLE NEUROSTIMULATOR
MDR report key: 2053604
·
Received March 1, 2011
Report
- Report Number
- 3004209178-2011-01519
- Event Type
- Malfunction
- Date Received
- March 1, 2011
- Date of Event
- January 1, 2011
- Report Date
- February 11, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NM, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
RECEIVED INFO THE INS WAS TURNING ITSELF OFF. SOMETIMES THE STIMULATION WOULD NOT TURN BACK ON UNTIL THE PT HAD WAITED AWHILE. SO HE NOW WAITS ABOUT 10 MINUTES AND USES THE PT PROGRAMMER TO TURN STIMULATION BACK ON AGAIN. THE INS STARTED DOING THIS ABOUT ONE MONTH AGO. PT ALSO NOW HAS STIMULATION IN HIS LEFT LEG, WHICH HE DID NOT HAVE BEFORE. ADD'L INFO HAS BEEN REQUESTED AND IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT. REFER TO MFR REPORT # 3004209178-2011-01520 FOR ADD'L INS SYSTEM.
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 | 71 YR | EXPLANTED:| LOT # NAT150409H| EXTENSION: MODEL 37082, LOT # NKB003180N| IMPLANTED:| ACCESSORY: MODEL 37752, LOT # NKA028629N| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR MODEL: 7425,| EXPLANTED:| LEAD: MODEL 3587A, LOT # L70301| LEAD: MODEL 3998, LOT # V027462| PROGRAMMER: MODEL 7434A, LOT # NGL022018P| PROGRAMMER: MODEL 37742, LOT # NJD055146N| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 7495-51, LOT # XR0065385N |