FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 1944300
·
Received December 6, 2010
Report
- Report Number
- 3004209178-2010-10228
- Event Type
- Malfunction
- Date Received
- December 6, 2010
- Date of Event
- November 24, 2010
- Report Date
- November 24, 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 IMPLANTABLE NEUROSTIMULATOR WAS IN A POWER ON RESET CONDITION. THE PT CALLED TECHNICAL SERVICES FOR ASSISTANCE. ACTION (NOT SPECIFIED) WAS TAKEN THAT RESOLVED THE POWER ON RESET ISSUE. ADDITIONAL INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SUBMITTED IF ADDITIONAL INFO 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 | 40 YR | EXPLANTED:| LEAD: MODEL 3776, LOT# V174996023| IMPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE144423N| ACCESSORY: MODEL 37752, LOT# NKA138890N| EXPLANTED:| LEAD: MODEL 3776, LOT# V272705035 |