FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 2040762
·
Received March 22, 2011
Report
- Report Number
- 3004209178-2011-02203
- Event Type
- Malfunction
- Date Received
- March 22, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 8, 2011
- 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
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PT HAD AN OUT OF REGULATION (OOR) MESSAGE ON THE PT'S PROGRAMMER. THE IMPEDANCES WERE MEASURED AND ELECTRODE 2 HAD >10,000 OHMS. ELECTRODE 3 IMPEDANCE MEASUREMENT WAS 9000 OHMS. THE STIMULATOR WAS REPROGRAMMED, AND COVERAGE WAS ACHIEVED FOR THE PT'S LEFT LEG, BUT NOT HER RIGHT LEG. DUE TO SOME OTHER HEALTH ISSUES, THE PT WAS NOT GOING TO HAVE A REVISION AT THIS TIME.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ULTRA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37712 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | PROGRAMMER: MODEL 37743, LOT# NKE102201N| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# L46788| ACCESSORY: MODEL 37752, LOT# NKA112115N| IMPLANTED:| EXTENSION: MODEL 37083, LOT# NKC011484N| IMPLANTED:| EXPLANTED:| STIM ACCESSORY: MODEL 3550-29, LOT# N142754 |