FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 1800089
·
Received August 11, 2010
Report
- Report Number
- 3004209178-2010-06029
- Event Type
- Malfunction
- Date Received
- August 11, 2010
- Date of Event
- January 1, 2010
- Report Date
- July 12, 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
- NJ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4)
Description of Event or Problem · 1
IT WAS REPORTED THAT PT DID NOT HAVE, AND HAS NEVER HAD, STIMULATION IN THE MIDDLE OF HIS BACK. PT STATED THAT THE DEVICE IS NOT "SET UP RIGHT" OR THAT THE "MACHINE IS IN THE WRONG PLACE." PT FURTHER STATED HE HAD BEEN REPROGRAMMED MULTIPLE TIMES AND HAD NOT BEEN ABLE TO GET STIMULATION COVERAGE IN HIS SHOULDER AREA. COMPANY REP CONFIRMED PT HAD BEEN REPROGRAMMED 2-3 TIMES. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
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 | 60 YR | IMPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT # NKE1004453N| IMPLANTED:| LEAD: MODEL 39565-65, LOT # V387293029| ACCESSORY: MODEL 37752, LOT # NKA136330N| EXPLANTED:| EXPLANTED: |