FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 1950058
·
Received December 7, 2010
Report
- Report Number
- 3004209178-2010-10294
- Event Type
- Malfunction
- Date Received
- December 7, 2010
- Date of Event
- November 29, 2010
- Report Date
- November 29, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- 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
THE PT WAS NOT ABLE TO ADJUST STIMULATION. THE ICON "CALL YOU DOCTOR" DISPLAYED. A POWER ON RESET (POR) OCCURRED. THE PT WAS ABLE TO CLEAR THE POR WHICH RESOLVED THE ISSUE. THE NEUROSTIMULATOR (INS) WAS 50-70% FULL AND THE PT HAD EXCELLENT COUPLING EFFICIENCY.
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 | 55 YR | EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB042528V| EXTENSION: MODEL 37081, LOT# NJB042527V| IMPLANTED:| EXPLANTED:| LEAD: MODEL 39565-30, LOT# N191544003| ACCESSORY: MODEL 37752, LOT# NKA127004N| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE115219N| IMPLANTED: |