RESTORE
Report
- Report Number
- 3004209178-2013-01020
- Event Type
- Malfunction
- Date Received
- January 28, 2013
- Report Date
- January 8, 2013
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-30, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: LEAD: PRODUCT ID 37752, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37743, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: EXTENSION: PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008. PRODUCT TYPE: EXTENSION. (B)(4).
IT WAS REPORTED THAT A PATIENT WAS UNABLE TO KEEP A DEVICE BATTERY RECHARGED AFTER BEING SENT THROUGH AIRPORT SECURITY. DEVICE INTERROGATION SHOWED THAT THE PATIENT WAS RUNNING THREE PROGRAMS WITH FOUR ELECTRODES EACH AT 6.7 VOLTS AND A RATE OF 70 FOR 24 HOURS A DAY. IT WAS REPORTED THAT THE PATIENT WAS ABLE TO OBTAIN MAXIMUM COUPLING WITH THE DEVICE AND THE RECHARGER. THE PATIENT WAS GOING TO TRY A NEW RECHARGER AND REPORT BACK IN TWO WEEKS. THE PATIENT SUFFERED NO INJURY OR ADVERSE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD NOT EXPERIENCE "ANY ISSUES" WITH RECHARGING SINCE RECEIVING THE NEW RE CHARGER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 37448 | RESTORE | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |