FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 2190980
·
Received July 19, 2011
Report
- Report Number
- 3004209178-2011-05551
- Event Type
- Malfunction
- Date Received
- July 19, 2011
- Date of Event
- June 1, 2011
- Report Date
- June 23, 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
- AZ, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THT THE PT EXPERIENCED A PROBLEM WITH COUPLING AND/OR COMMUNICATION ISSUES. THE PT LAST FELT STIMULATION AND LAST RECHARGED 3 WEEKS AGO. THIS INS MAY HAVE FLIPPED AND APPEARED THE DEVICE HAD MOVED. IT WAS ALSO REPORTED THAT THE PT COULD NOT ADJUST STIMULATION.
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 | 51 YR | PROGRAMMER: MODEL 37743, LOT# NKE142028N| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3777, LOT# V384637001| LEAD: MODEL 3777, LOT# V257607014| ACCESSORY: MODEL 37752, LOT# NKA136279N |