RESTORE ULTRA
Report
- Report Number
- 3004209178-2013-12928
- Event Type
- Malfunction
- Date Received
- August 7, 2013
- Report Date
- May 19, 2014
- 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
- AZ, US
- Reporter Occupation
- OTHER
Narratives
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER, PRODUCT ID 37092, LOT# 239330001, IMPLANTED: 2010-(B)(6), PRODUCT TYPE ACCESSORY, PRODUCT ID 3987A, LOT# N183268, IMPLANTED: 2010-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3987A, LOT# N183265, IMPLANTED: 2010-(B)(6), PRODUCT TYPE LEAD PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: 2010-(B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 3708360, SERIAL# (B)(4), IMPLANTED: 2010-(B)(6), PRODUCT TYPE EXTENSION. (B)(4).
(B)(4).
(B)(4).
(B)(4)
(B)(4).
(B)(4).
IT WAS REPORTED THAT THE PATIENT¿S BATTERY PACK WAS TURNED AROUND. IT WAS NOTED THAT IT HAD NOT BEEN WORKING FOR 1.5 YEARS PRIOR TO THIS REPORT. PATIENT HAD DEBILITATING MIGRAINES. DEVICE WAS IMPLANTED FOR PAIN. ADDITIONAL INFORMATION REQUESTED BUT HAD NOT BEEN RECEIVED AS OF THE DATE OF THIS REPORT.
IT WAS LATER REPORTED ON (B)(6) 2013 THAT THE PATIENT EXPERIENCED NO STIMULATION SENSATION . THE INS WAS IMPLANTED IN HER NECK FOR MIGRAINES. THE INS HAS SLIPPED AND HAS BEEN ¿INOPERATIVE¿ SINCE. IT WAS UNKNOWN WHAT INOPERATIVE MEANT. SHE WAS VERY THIN AND IT WAS UNKNOWN HOW THE INS MOVED. IT WAS NOTED THAT SHE DOES NOT HAVE A MANAGING PHYSICIAN DUE TO NOT HAVING INSURANCE.
IT WAS FURTHER REPORTED THE PATIENT HAD PROBLEMS WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) TURNING IN THE POCKET PRETTY MUCH IT WAS IMPLANTED IN (B)(6) 2010. IT WAS NOTED ONE NIGHT PRIOR TO REPORT THE PATIENT SLEPT WRONG AND IT SWELLED UP THE WORST IT EVER HAD AND THE PATIENT HAD TO GO THE EMERGENCY ROOM. IT WAS REPORTED THE PATIENT COULD NOT TAKE A STEP WITHOUT PAIN. IT WAS FURTHER REPORTED THE PATIENT MOVED 1.5 YEARS AGO AND WAS UNABLE TO CHARGE THEIR DEVICE.
IT WAS REPORTED THERE WAS AN ¿ISSUE¿ WITH THE PATIENT¿S DEVICE. IT WAS REPORTED THE IMPLANTABLE NEUROSTIMULATOR (INS) IS ¿NOT WORKING¿ AND IS ¿PULLED SIDEWAYS¿. IT WAS FURTHER REPORTED WHEN THE DEVICE ¿TURNED¿ IT ALSO ¿PULLED THE WIRES¿. IT WAS NOTED THE INS TURNED WHEN THE PATIENT WAS ATTEMPTING TO CHARGE THEIR DEVICE ONE YEAR PRIOR TO REPORT. IT WAS FURTHER REPORTED THE PATIENT WAS IN THE ER ONE WEEK PRIOR TO REPORT AND WAS RECORDED IN A PREVIOUS CALL. IT WAS REPORTED THE PATIENT HAD A RETURN OF MIGRAINES, BACK PAIN AND SWELLING DUE TO THE ¿MACHINE MOVING IN THEIR BACK¿. IT WAS REPORTED THE DEVICE WAS LAST CHARGED ONE YEAR PRIOR TO REPORT. IT WAS FURTHER NOTED THE PATIENT WAS SEEING AN ERROR CODE OF 006 WAS SEEN ON THE IMPLANTABLE NEUROSTIMULATOR RECHARGER (INSR). IT WAS REPORTED THE DEVICE WAS IN POSSIBLE OVER-DISCHARGE DUE TO NOT BEING CHARGED FOR ONE YEAR. LASTLY IT WAS REPORTED THE PATIENT WAS IN ¿LOTS OF PAIN¿.
ADDITIONAL INFORMATION RECEIVED REPORTED AN OVER-DISCHARGE WAS SUSPECTED. IT WAS PREVIOUSLY REPORTED THE PATIENT HAD AN ERROR CODE OF 006 SO THEY HAD BEEN UNABLE TO RECHARGE THEIR DEVICE AND IT HAD BEEN MORE THAN 50 DAYS. INFORMATION REGARDING OTHER DEVICE ISSUES AND SYMPTOMS RECORDED IN PREVIOUS CALLS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 370687 | 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 | 00043 YR |