RESTORE ULTRA
Report
- Report Number
- 3004209178-2012-09072
- Event Type
- Injury
- Date Received
- October 10, 2012
- Report Date
- September 18, 2012
- 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
- CA, US
- Reporter Occupation
- OTHER
Narratives
PRODUCT ID, 377875 LOT# V005100 SERIAL#, IMPLANTED: 2006 (B)(6), EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID, 377875 LOT# V005100 SERIAL#, IMPLANTED: 2006 (B)(6), EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID, 37752 LOT# SERIAL# (B)(4), IMPLANTED: EXPLANTED: PRODUCT TYPE RECHARGER PRODUCT ID, 37743 LOT# SERIAL# (B)(4), IMPLANTED: EXPLANTED: PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS HAVING COUPLING AND/OR COMMUNICATION ISSUES. THE PATIENT STATED SHE WAS UNABLE TO RECHARGE HER DEVICE, THAT SHE CHARGED FOR 12 HOURS, IT DID NOT CHARGE, AND THE BATTERY DEPLETED REAL QUICK WHERE IT WOULD BE DEPLETED BY THE MORNING. THE PATIENT NOTED THAT SHE CHARGED WITH IT CONNECTED TO THE WALL. THE PATIENT INDICATED THAT SHE NOTICED IT STARTED DEPLETING SINCE SHE GOT IT AND SHE HAD TO RECHARGE EVERY DAY. THE PATIENT WOULD MOVE AROUND WHILE RECHARGING, AND HAD 4 BARS AND IT WAS FLICKERING BUT IT HAD BEEN FLICKERING THE SAME AMOUNT. MOST OF THE TIME, THE PATIENT DID NOT HAVE ANY COUPLING BARS AND THE STIMULATOR MOVED AROUND A LOT. THE PATIENT JUST GOT APPROVAL FOR A REVISION BECAUSE THE DEVICE TURNS AND MOVES INTO HER RIBS. THE PATIENT STATED IT HAD BEEN THAT WAY SINCE ABOUT 6 MONTHS AFTER THE SURGERY AND SHE TOLD HER DOCTOR ABOUT IT 3 MONTHS AGO. THAT PATIENT STATED THAT IN 'B)(6) 2012' THE DEVICE WAS FLIPPING AND HER DOCTOR TOLD HER THE DEVICE SHOULD STILL CHARGE EVEN IF IT WAS FLIPPED. THE PATIENT WAS TOLD TO WEAR A BRACE. THE LAST TIME SHE WENT INTO THE DOCTOR AND TO SEE THE MANUFACTURE REPRESENTATIVE, TWO OF HER LEADS WERE LEAKING. THE PATIENT STATED HER LEADS HAVE COME OUT. THE PATIENT NOTED THAT IN (B)(6) 2012 WAS WHEN SHE WENT INTO THE DOCTOR AND FOUND OUT ABOUT THE BROKEN LEADS AND IT WAS NOT PLEASANT. THE PATIENT HAD NOT SEEN ANY DOCTOR SINCE BECAUSE THE DOCTOR WAS OUT WITH A BROKEN LEG. SHE HAD AN APPOINTMENT WITH HER DOCTOR ON (B)(6) AND WAS NOT TAKING ANY MEDICATION. THE PATIENT STATED IT COULD BE VERY PAINFUL FROM RECHARGING SO LONG AND HAD TRIED EVERYTHING. ADDITIONAL REVIEW INDICATES THE INFORMATION IN MFR REPORT # 3004209178-2012-09265 PERTAINS TO THIS MANUFACTURER'S REPORT. ANY ADDITIONAL INFO WILL BE REPORTED IN THIS REPORT.
IT WAS INITIALLY REPORTED THAT THE PATIENT WAS CHARGING THEIR IMPLANTABLE NEUROSTIMULATOR (INS) MORE THAN EXPECTED. IT WAS NOTED THAT THEY USE TO CHARGE FROM EMPTY TO FULL TO FULL EVERY 2 TO 4 WEEKS BUT NOW NEEDED TO CHARGE EVERY WEEK. THE PATIENT STATED "THE INS WAS DRAINING". ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD DIFFICULTY COUPLING (ONLY 4 BARS) THEIR RECHARGER UNIT WITH INS. IT WAS ALSO NOTED THAT THE PATIENT'S SKIN "BREAKS DOWN" DUE TO THE RECHARGING COUPLING DIFFICULTY. IT WAS REPORTED THAT THE PATIENT HAD THE INS SURGICALLY MOVED SEVERAL TIMES (5 TIMES SINCE IMPLANTATION WITH THE LAST ONE OCCURRING LAST YEAR) AND SAW A PLASTIC SURGEON TO HAVE THE INS PLACEMENT ASSESSED. IN ADDITION, THE PATIENT HAD REVISIONS PERFORMED ON SCAR TISSUE BECAUSE OF THE PAIN THEY CAUSED, WITH THE LAST SCAR REVISION OCCURRING LAST YEAR. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 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 | 00038 YR | Required Intervention |