FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 1935954
·
Received December 3, 2010
Report
- Report Number
- 3004209178-2010-10201
- Event Type
- Malfunction
- Date Received
- December 3, 2010
- Date of Event
- January 1, 2010
- Report Date
- November 23, 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
- CO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT EXPERIENCED SURGING SENSATION DURING ELECTRICAL STORMS. THE PT LIVED AT 10,000 FT. SHE ALSO FELT STIMULATION CHANGES WITH POSITIONAL CHANGES. THE PT WAS AT HOME. HER STATUS WAS REPORTED AS GOOD. ADDITIONAL INFORMATION HAS BEEN REQUESTED. A F/U 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 | LEAD: MODEL 3888, LOT# V297219| IMPLANTED:| EXPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA132251N| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3888, LOT# V229128| PROGRAMMER: MODEL 37743, LOT# NKE134986N| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB003571V| EXPLANTED:| LEAD: MODEL 3777, LOT# V309556012| EXPLANTED: |