FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 1944191
·
Received December 6, 2010
Report
- Report Number
- 3004209178-2010-10249
- Event Type
- Malfunction
- Date Received
- December 6, 2010
- Date of Event
- January 1, 2010
- Report Date
- November 24, 2010
- 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
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PATIENT FELT PAIN AT THE IMPLANTABLE NEUROSTIMULATOR AND LEAD SITE CAUSED BY THE IMPLANTABLE NEUROSTIMULATOR. THE DEVICE HADN'T WORKED FOR A YEAR. IT WAS REPORTED THAT WIRES WERE LOOSE. THE PATIENT DID NOT HAVE A DEVICE-MANAGING HCP AT THE TIME OF REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION 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 | 53 YR | LEAD: MODEL 3777, LOT# V081592015| ACCESSORY: MODEL 37752, LOT# NKA111611N| PROGRAMMER: MODEL 37743, LOT# NKE103261N| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3777, LOT# V081592014| IMPLANTED: |