FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 1950369
·
Received December 14, 2010
Report
- Report Number
- 3004209178-2010-10484
- Event Type
- Malfunction
- Date Received
- December 14, 2010
- Report Date
- December 3, 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 THE DISPLAY SHOWED A "CALL YOUR DOCTOR ICON" AND WARNING POR (POWER-ON RESET). IT WAS FURTHER NOTED THAT THE PT WAS NOT ABLE TO ADJUST STIMULATION. NO PT TREATMENT OR OUTCOME WAS REPORTED. ADDITIONAL INFORMATION 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 | IMPLANTED:| LEAD: MODEL 39565-30, LOT# V297513029| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB067240V| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB067239V| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE135130N| ACCESSORY: MODEL 37752, LOT# NKA132392N |