FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 1926385
·
Received November 11, 2010
Report
- Report Number
- 3004209178-2010-09273
- Event Type
- Malfunction
- Date Received
- November 11, 2010
- Date of Event
- November 4, 2010
- Report Date
- November 4, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT REC'D A "TIMER" DISPLAY ON HIS PT PROGRAMMER WHICH RAN FOR EXACTLY 7 MINUTES. HE WAS EDUCATED ON HOW TO TURN THE TIMER OFF. HE THEN REC'D A "SYNCH NOW MESSAGE" SCREEN. HE THEN TOOK HIS RECHARGER AND REC'D THE MESSAGE "CALL YOUR DOCTOR" ICON, A POWER ON RESET OCCURRED. IT CHANGED RIGHT AFTER TO COUPLING BARS THEN HE REPOSITIONED SLIGHTLY TO GET ALL COUPLING BARS. FURTHER INFORMATION HAS BEEN REQUESTED.
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 | 46 YR | LEAD: MODEL 3487A, LOT# V235029| PROGRAMMER: MODEL 37743, LOT# UNK| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# V235029| EXPLANTED:| LEAD: MODEL 3777, LOT# V239555038| EXPLANTED:| IMPLANTED:| IMPLANTED: |