FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 1993760
·
Received January 13, 2011
Report
- Report Number
- 3004209178-2011-00351
- Event Type
- Malfunction
- Date Received
- January 13, 2011
- Date of Event
- January 1, 2011
- Report Date
- January 3, 2011
- 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
- SC, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S DEVICE "CUT OFF" WITH SUBSEQUENT LOSS OF STIMULATION SENSATION AFTER GOING TO A WALMART STORE. THE PT WAS ABLE TO GET A RECHARGER SCREEN WITH THE EXTERNAL RECHARGER UNIT. IT WAS NOTED THAT THE PT HAD NOT CHARGED IN OVER A MONTH AND IT WAS POSSIBLE THAT THE DEVICE WAS IN AN OVERDISCHARGE CONDITION. THE PT WAS AT HOME IN FAIR CONDITION. ADD'L INFO WAS 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 | 50 YR | EXPLANTED:| LEAD: MODEL 39286-65, LOT# V483909021| PROGRAMMER: MODEL 37743, LOT# NKE152959N| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA146605N |