FDA Adverse Event
Malfunction
Summary report: N
RESTORE
MDR report key: 3475598
·
Received November 18, 2013
Report
- Report Number
- 3004209178-2013-21013
- Event Type
- Malfunction
- Date Received
- November 18, 2013
- Report Date
- October 31, 2013
- 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
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 377860, LOT# V004741, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 377860, LOT# V003916, IMPLANTED: 2006 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37742, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37752, SERIAL# (B)(4), IMPLANTED: 2006 (B)(6); PRODUCT TYPE RECHARGER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WAS CHARGING MORE THAN EXPECTED AND THE BATTERY WAS DEPLETING "QUICKER" THAN NORMAL. IT WAS NOTED THAT THE DEVICE HAD NOT BEEN CHECKED IN "AWHILE". IT WAS REPORTED THAT THE PATIENT HAD TO INCREASE STIMULATION MORE DUE TO INCREASED PAIN. IT WAS NOTED THAT THE PATIENT BELIEVED SHE HAD BEEN DOING "TOO MUCH" ACTIVITY BECAUSE SHE RECENTLY MOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 596698 | RESTORE | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00078 YR |