FDA Adverse Event
Malfunction
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 2181461
·
Received July 5, 2011
Report
- Report Number
- 3004209178-2011-05101
- Event Type
- Malfunction
- Date Received
- July 5, 2011
- Date of Event
- January 1, 2011
- Report Date
- June 9, 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
- OH, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT IN BOTH KNEES FOLLOWING A FALL. APPROX FIVE TIMES IN THE PAST YEAR THE PT FELL LANDING ON THE KNEE, WHICH IS WHERE THE STIMULATION WAS DIRECTED. ADD'L INFO HAS BEEN REQUESTED. A FOLLOW-UP REPORT WILL BE SENT WHEN ADD'L INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESTORE ADVANCED RECHARGEABLE | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37713 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | EXPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD053899N| ACCESSORY: MODEL 37752, LOT# NKA018440N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3777, LOT# V054422013| IMPLANTED:| LEAD: MODEL 3777, LOT# V053943037 |