FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 1941168
·
Received December 22, 2010
Report
- Report Number
- 3004209178-2010-10662
- Event Type
- Malfunction
- Date Received
- December 22, 2010
- Date of Event
- December 9, 2010
- Report Date
- December 9, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, 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. A "CALL YOU DOCTOR" ICON DISPLAYED. A POWER ON RESET (POR) OCCURRED FOR AN UNK REASON. THE NEUROSTIMULATOR (INS) WAS 3/4 CHARGED. THE POR WAS CLEARED BY: SYNCHING THE PT PROGRAMMER, PRESSING THE NAVIGATOR KEY AND WHEN THE TIME WAS DISPLAYED ON THE PT PROGRAMMER PRESSED THE NAVIGATOR KEY AGAIN. THIS ISSUE WAS RESOLVED.
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 | 59 YR | PROGRAMMER: MODEL 37743, LOT# NKE113062N| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB018524V| IMPLANTED:| LEAD: MODEL 39565-30, LOT# N160396007| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA117385N| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB8034411V| IMPLANTED: |