RESTORE ULTRA
Report
- Report Number
- 3004209178-2013-08724
- Event Type
- Malfunction
- Date Received
- June 6, 2013
- Report Date
- May 16, 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 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE LEAD. (B)(4).
ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENTS IMPLANTABLE NEUROSTIMULATOR WAS CHARGED AND THE MANUFACTURING REPRENTATIVE "PERFORMED A POR." IT WAS NOTED THE PATIENT'S THERAPY RESUMED AS NORMAL.
ADDITIONAL INFORMATION FOUND IT WAS FURTHER REPORTED THE CLINICIAN PROGRAMMER WAS NOT COMMUNICATING WITH THE IMPLANTABLE NEUROSTIMULATOR (INS).
IT WAS REPORTED THAT THERE WERE TELEMETRY ISSUES. IT WAS NOTED THAT THE PATIENT HAD TWO PRIOR OVERDISCHARGES AND IS IN OVERDISCHARGE AGAIN. IT WAS ALSO NOTED THAT THERE WAS A POWER ON RESET (POR) MESSAGE THAT BEGAN 3 WEEKS PRIOR TO THE DATE OF THE REPORT. IT WAS LATER REPORTED THAT THE PATIENT WAS ABLE TO RECHARGE IS IMPLANTED DEVICE BUT HE DID NOT SHOW UP FOR HIS POR APPOINTMENT. IT WAS NOTED THAT IT WOULD BE RESCHEDULED FOR (B)(6) 2013.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 251112 | 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 | 00050 YR |