FDA Adverse Event
Malfunction
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 1930302
·
Received November 24, 2010
Report
- Report Number
- 3004209178-2010-09925
- Event Type
- Malfunction
- Date Received
- November 24, 2010
- Date of Event
- November 1, 2010
- Report Date
- November 16, 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
- MO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
INFORMATION RECEIVED REPORTS PATIENT WAS IN A CAR ACCIDENT IN EARLY NOVEMBER AND SINCE THAT TIME, SHE FEELS STIMULATION SENSATION IS MUCH STRONGER. PATIENT STATES IT IS STRONG ENOUGH NOW THAT SHE HAS TO LOWER THE STIMULATION SETTING. SHE STILL HAS STIMULATION IN THE CORRECT LOCATION SAME AS BEFORE THE ACCIDENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
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 | 51 YR | EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB014853N| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3888, LOT# V177972| EXPLANTED:| LEAD: MODEL 3487A, LOT# V160153| IMPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3888, LOT# V162341| EXTENSION: MODEL 37082, LOT# NKB015884N| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA119810N| LEAD: MODEL 3487A, LOT# V160153| IMPLANTED: |