FDA Adverse Event
Malfunction
Summary report: N
RESTORE
MDR report key: 3801912
·
Received May 9, 2014
Report
- Report Number
- 3004209178-2014-08774
- Event Type
- Malfunction
- Date Received
- May 9, 2014
- Date of Event
- April 17, 2014
- Report Date
- April 18, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 377845, LOT# V010649, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 377845, LOT# V007757, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_PROG, SERIAL# UNKNOWN, PRODUCT TYPE PROGRAMMER, PHYSICIAN. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT SAW ¿DONE¿ AND ¿2006¿ ON THE PROGRAMMER SCREEN. IT WAS NOTED THE PATIENT¿S STIMULATION STOPPED WORKING THE NIGHT PRIOR TO CALL. IT WAS REPORTED THE PATIENT WAS ABLE TO GET STIMULATION BACK ON BY TURNING HE STIMULATOR ON AND OFF MULTIPLE TIMES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 281820 | RESTORE | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00054 YR |