RESTORE ULTRA
Report
- Report Number
- 3007566237-2013-01153
- Event Type
- Malfunction
- Date Received
- April 8, 2013
- Report Date
- March 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
- MN, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
CONCOMITANT PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 3550-41, LOT# N297993, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE EXTENSION; PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37712, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. THE INITIAL MDR WAS FILED AS MFR REPORT #3007566237-2013-01153.
(B)(4).
IT WAS REPORTED THAT THE MANUFACTURER REPRESENTATIVE WAS NOT ABLE TO ADJUST STIMULATION. A POWER-ON-RESET (POR) WAS REPORTED. THE CAUSE OF THE POR WAS NOT KNOWN. THE MANUFACTURER REPRESENTATIVE WAS PROVIDED WITH INSTRUCTIONS FOR CLEARING THE POR CONDITION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
IT WAS LATER REPORTED THAT THE PATIENT WAS ABLE TO CLEAR THE POR WITH HER PROGRAMMER AND IT WORKED PERFECTLY. SEE ALSO MFR. REP. # 3004209178-2013-07460.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 143454 | RESTORE ULTRA | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 37712 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |