FDA Adverse Event
Malfunction
Summary report: N
RESTORE ULTRA
MDR report key: 1659290
·
Received April 13, 2010
Report
- Report Number
- 3004209178-2010-02973
- Event Type
- Malfunction
- Date Received
- April 13, 2010
- Date of Event
- March 17, 2010
- Report Date
- March 17, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B) (4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT; NO STIMULATION WAS FELT REGARDLESS OF CHANGES IN PARAMETERS. TROUBLESHOOTING REVEALED HIGH IMPEDANCES; BATTERY STATUS WAS NORMAL. THERE WAS NO TRAUMA OR INJURY EXPERIENCED PRIOR TO THIS EVENT HOWEVER, THE PATIENT HAD BEGUN ENGAGING IN MINIMAL EXERCISE SUCH AS SLOW BIKE PEDALING AND GENTLE LEG SWINGS. A FOLLOW-UP WILL BE SENT WHEN 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 | 61 YR | EXPLANTED:| IMPLANTED:| LEAD: MODEL 3986A, LOT# N071373| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA133886N| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB069189V| IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 37083, LOT# NKC011117N| IMPLANTED:| PROGRAMMER: MODEL 37743, LOT# NKE137885N |