FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 1834580
·
Received September 9, 2010
Report
- Report Number
- 3004209178-2010-06907
- Event Type
- Malfunction
- Date Received
- September 9, 2010
- Report Date
- August 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
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED PT'S BATTERY OVERDISCHARGED. PT HAD TELEMETRY ISSUES. THERE WAS A PREVIOUS INSTANCE OF OVERDISCHARGE. A PHYSICIAN MODE RECHARGE (PMR) WAS SUCCESSFUL. THE PT EXPERIENCED A POWER ON RESET FOLLOWING THE PMR. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND WILL BE MADE AS FOLLOW UP AS IT BECOMES AVAILABLE.
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:| EXPLANTED:| LEAD: MODEL 39565-30, LOT# N142678002| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE106143N| ACCESSORY: MODEL 37752, LOT# NKA113223N| IMPLANTED: |