FDA Adverse Event
Malfunction
Summary report: N
RESTORE ADVANCED
MDR report key: 4232914
·
Received November 6, 2014
Report
- Report Number
- 9614453-2014-02589
- Event Type
- Malfunction
- Date Received
- November 6, 2014
- Date of Event
- October 1, 2012
- Report Date
- November 6, 2014
- Manufacturer
- IPG MFG SWITZERLAND
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT COULD ¿MOVE THE INS¿ AND THAT SHE COULD ALSO ¿PUT HER FINGERS ALL THE WAY AROUND THE INS¿ IN 2013. AS OF 40 DAYS AFTER INITIAL REPORT THERE HAD BEEN ¿NO INTERVENTIONS¿ PLANNED. THE PATIENT REPORTEDLY STILL HAD STIMULATION AND HER INS BATTERY WAS HALF FULL AT THE TIME OF INITIAL REPORT. THE PATIENT¿S INS CHARGED ¿JUST FINE¿ AT THE TIME OF REPORT. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 712866 | RESTORE ADVANCED | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | IPG MFG SWITZERLAND | 37713 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |