FDA Adverse Event
Malfunction
Summary report: N
RESTORE ADVANCED RECHARGEABLE
MDR report key: 2043183
·
Received March 25, 2011
Report
- Report Number
- 3004209178-2011-02317
- Event Type
- Malfunction
- Date Received
- March 25, 2011
- Date of Event
- March 1, 2010
- Report Date
- March 10, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED, THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. IT WAS STATED, THE PT WAS IN A CAR ACCIDENT IN (B)(6) 2010, AND THAT THE PT WAS "KICKED IN THE IMPLANTABLE NEUROSTIMULATOR AREA AFTER THAT". SINCE THEN, IT WAS STATED, THE PT WAS EXPERIENCING PROBLEMS WITH THEIR THERAPY. THE PT WAS REFERRED TO THEIR HEALTH CARE PROVIDER. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A F/U REPORT WILL BE SENT IF ADDITIONAL INFORMATION 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 | 55 YR | EXPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED,| IMPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD063929N| EXPLANTED:| LEAD: MODEL 39565-30, LOT# N137406001| IMPLANTED:| EXTENSION: MODEL 37081, LOT# NJB026196V| IMPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT# NKA036782N| EXPLANTED:| EXTENSION: MODEL 37081, LOT# NJB026195V |