RESTORE ULTRA
Report
- Report Number
- 3004209178-2013-04508
- Event Type
- Malfunction
- Date Received
- April 2, 2013
- Report Date
- March 6, 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
- MN, US
- Reporter Occupation
- OTHER
Narratives
PRODUCT ID: 3776-75 LOT# SERIAL# (B)(4), IMPLANTED: 2013 (B)(6), PRODUCT TYPE LEAD. (B)(4).
(B)(4).
ADDITIONAL INFORMATION. IT WAS REPORTED AN INTERROGATION OF THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) FOUND THAT THE DEVICE HAD ONLY BEEN ON 41% OF THE TIME. IT WAS NOTED THAT CYCLING WASN'T PROGRAMMED.
IT WAS REPORTED, THE DEVICE WOULD BE "WORKING AND THEN JUST CUT OFF." IT HAD DONE THIS NUMEROUS TIMES AND CONTINUED TO OCCUR AS OF (B)(6) 2013. INTERROGATION WITH A PROGRAMMER FOUND NOTHING WRONG. X-RAYS WERE DONE AND "NOTHING SHOWED UP." ON (B)(6) 2013, THE PATIENT MET WITH A MANUFACTURER'S REPRESENTATIVE WHO "TWEAKED" THE DEVICE AND LEFT IT ON. IT WAS REPORTED THAT 30 MINUTES LATER "IT CUT OFF." ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT WAS GETTING ¿GREAT THERAPY¿ NOW. IMPEDANCES WERE FINE WITH THE IMPLANTABLE NEUROSTIMULATOR. IT WAS REPORTED THAT NO MALFUNCTIONS WERE ¿SEEN OR CAUSED.¿
IT WAS REPORTED THAT POSITIONAL CHANGES ARE AFFECTING THE STIMULATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 134483 | 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 |