RESTORE
Report
- Report Number
- 3004209178-2013-03438
- Event Type
- Malfunction
- Date Received
- March 7, 2013
- Report Date
- February 19, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
PRODUCT ID 748951, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 748951, SERIAL # (B)(4), IMPLANTED: (B)(6) 2006, PRODUCT TYPE EXTENSION; PRODUCT ID 3998, LOT # J0504327V, IMPLANTED: (B)(6) 2005, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37743, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER.
IT WAS REPORTED THAT THE PATIENT'S DEVICE "HAD NOT WORKED" IN 6 MONTHS AND HE HAD BEEN TRYING TO CHARGE IT SINCE THEN. COUPLING AND/OR COMMUNICATION ISSUES WERE REPORTED. IT WAS SUSPECTED THAT THE IMPLANTABLE NEUROSTIMULATOR (INS) MAY HAVE BEEN FLIPPED BUT WASN'T CONFIRMED AT THE TIME OF THE REPORT. NO FURTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
IT WAS REPORTED THE PATIENT EXPERIENCED COUPLING AND OR COMMUNICATION ISSUES. IT WAS REPORTED THE PATIENT¿S DEVICE HAD NOT WORKED IN 6 MONTHS AND HE HAD BEEN TRYING TO CHARGE SINCE THEN AND IT WOULD NOT TAKE A CHARGE. IT WAS NOTED THE PATIENT ¿COULD NOT EVEN TURN IT ON¿ AND THAT THE BATTERY WAS DEAD. IT WAS REPORTED THE PATIENT WAS GETTING 0 COUPLING BOXES. IT WAS LOGGED THE DEVICE WAS NOT IN OVERDISCHARGE. IT WAS LOGGED THE INS MAY HAVE BEEN FLIPPED. IT WAS NOTED THE FLIP WAS NOT CONFIRMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 96756 | RESTORE | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |