RESTORE ULTRA
Report
- Report Number
- 3004209178-2013-07401
- Event Type
- Malfunction
- Date Received
- May 8, 2013
- Report Date
- April 18, 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
- IN, US
- Reporter Occupation
- OTHER
Narratives
(B)(4).
(B)(4).
CONCOMITANT PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE LEAD; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER. (B)(4).
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT DID NOT HAVE CONCERNS WITH HER DEVICE OR THERAPY.
IT WAS FURTHER REPORTED THAT THE PATIENT COULD NOT SYNC. IT WAS NOTED THAT THE PATIENT SAW A QUESTION MARK SCREEN ON THE PATIENT PROGRAMMER.
IT WAS REPORTED THE PATIENT WAS UNABLE TO ¿TURN DOWN HER STIMULATION LAST NIGHT.¿ THE REPORTER STATED SHE FELT LIKE SHE WAS ¿GETTING ELECTROCUTED.¿ IT WAS NOTED THE PATIENT WAS NOT ABLE TO MAKE ADJUSTMENTS WITH THE ANTENNA ATTACHED. IT WAS FURTHER NOTED THE PATIENT WAS ABLE TO TURN STIMULATION DOWN WITHOUT THE ANTENNA. FINAL ANALYSIS OF THE PATIENT PROGRAMMER REVEALED A TELEMETRY CIRCUIT FAILURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 201169 | 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 |