RESTORE
Report
- Report Number
- 3004209178-2013-07679
- Event Type
- Malfunction
- Date Received
- May 15, 2013
- Report Date
- April 22, 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
- MO, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
(B)(4).
PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT, ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37742, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: PROGRAMMER. (B)(4).
(B)(4).
UPON FURTHER REVIEW, IT WAS REPORTED THAT THE STIMULATION SYSTEM IS NO LONGER HAVING ANY AFFECT. IT WAS NOTED THAT THE PATIENT WAS NOT GETTING THE BENEFIT LIKE THEY USE TO.
IT WAS REPORTED THE PATIENT FELL ON HER DEVICE AND BROKE HER HIP/PELVIS ABOUT A MONTH AND A HALF AGO. FOR THE PAST 2 WEEKS, THE PATIENT HAD NOT BEEN GETTING STIMULATION OR THERAPY LIKE SHE WAS GETTING BEFORE; SHE COULD FEEL STIMULATION BUT IT WAS NOT IN THE SAME LOCATION AS BEFORE. IT WAS ALSO REPORTED THE PATIENT'S SCIATIC NERVE PAIN USED TO BE CONTROLLED BY THE DEVICE BUT NO LONGER WAS CONTROLLED. IT WAS NOTED THE PATIENT HAD ON SEVERAL OCCASIONS DISCHARGED COMPLETELY WHEN SHE WAS TRAVELLING AND HER SPOUSE WAS CONCERNED THAT THE BATTERY MAY BE WEAK. ADDITIONAL INFORMATION RECEIVED A WEEK LATER REPORTED THE PATIENT ALSO HAD RIGHT ARM AND HIP PAIN SINCE HER FALL ON (B)(6) 2013. THE PATIENT WAS EXPERIENCING PAIN FROM BUTT STIMULATOR, HIP TO LEG. IT WAS NOTED THE PATIENT WAS UNSURE IF SHE HAD DISLODGED A WIRE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 214123 | RESTORE | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |