BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2032479 · Received March 23, 2011

    Report

    Report Number
    3004209178-2011-02241
    Event Type
    Injury
    Date Received
    March 23, 2011
    Date of Event
    January 1, 2011
    Report Date
    March 3, 2011
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS STATED THAT AFTER CHARGING THE INS TO 50% FULL, THE PT PROGRAMMER INDICATED THE INS BATTERY WAS EMPTY. THERE WERE NO ABNORMAL RECHARGE CODES DISPLAYED AT THE TIME. THE PT HAD TWO STIMULATION SYSTEMS AND SHE NOTICED THAT THE INS BATTERY LEVEL WAS DECREASING MORE RAPIDLY SINCE SHE STARTED CHARGING BOTH SYSTEMS AT THE SAME TIME. AN ISSUE WAS NOT NOTICED WHEN CHARGING THE INS BATTERIES SEPARATELY. PRIOR TO (B)(6) 2011, THE PT COULD GO TWO OR THREE WEEKS BEFORE NEEDING THE RECHARGE AND NOW IT WAS NEEDED DAILY. IT WAS NOTED THAT THE PT HAD LOW PARAMETERS, WITH GROUP A1 SET A 1-,1+, 1.0V, 460 PULSE WIDTH, 20HZ AND GROUP A2 SET AT 1 CATHODE, 3 ANODES, 420 PULSE WIDTH, 20HZ. GROUP IMPEDANCES WERE IN THE NORMAL THERAPEUTIC RANGE. ON (B)(6) 2011, CHARGE WAS INITIATED AND IT APPEARED THE BATTERY WAS TAKING ON CHARGE. THE PT DID NOT GET ALL THE WAY TO THE FIRST INS FULL SCREEN DURING THE RECHARGING SESSION. SHE LEFT THE STIMULATION OFF ALL NIGHT AND WHEN CHECKING THE INS THE NEXT MORNING, THE INS BATTERY WAS AT 50%. IMPEDANCES AT THE TIME WERE IN THE RANGE OF 414-820 OHMS. THE PT HAD BEEN CHARGING EVERY DAY WITH THE STIMULATION TURNED OFF. SHE WAS STILL RECEIVING THERAPY AND THE STIMULATION SEEMED TO BE WORKING NORMALLY. AFTER OBTAINING FIVE GOOD RECHARGE SESSIONS, IT WAS OBSERVED THAT THE INS WAS DEPLETING WITHIN 24 HOURS. THE PT WAS INSTRUCTED TO USE THE STIMULATION ONLY WHEN NEEDED. ON (B)(6) 2011, IMPEDANCES WERE RUN AGAIN AND WERE STILL IN THE NORMAL RANGE WITH THE LOWEST BEING ELECTRODE PAIR 4, 12 AT IMPEDANCE OF 471 OHMS. THE PROGRAMMING WAS THEN: GROUP A1 SET AT 8-, 10+, .25V, 420 PULSE WIDTH, 40HZ WITH GROUP A1 IMPEDANCE AT 796 OHMS. GROUP A2 WAS SET TO 0.0V. OTHER INFO REPORTED INDICATED THAT THE PT FELL ONTO HER HANDS AND KNEES TEN DAYS AFTER IMPLANT WHICH RESULTED IN THE LEAD MIGRATING 1/2 INCH BUT SHE WAS STILL ABLE TO GET THERAPY. SHE WAS ALSO INVOLVED IN A CAR ACCIDENT ON (B)(6) 2011 IN WHICH SHE SUSTAINED WHIPLASH. AFTER THE ACCIDENT, SHE NEEDED TO HAVE THE STIMULATION AT 4.8V-5.0V AND A 500 PULSE WIDTH IN ORDER TO FEEL IT BUT WAS NOT COVERING HER SYMPTOMS WELL AND THERE WAS A THUMPING FEELING THAT WAS TOO STRONG. THE PT UNDERWENT REVISION SURGERY ON (B)(6) 2011 TO PUSH THE LEAD BACK UP INTO POSITION AS IT HAD MOVED DOWN ABOUT AN INCH AND WAS COILING UNDER THE SKIN. ON (B)(6) 2011, X-RAYS WERE OBTAINED WHICH INDICATED THAT THE LEAD HAD MIGRATED DOWN ONE VERTEBRAL SPACE, WITH THE TIP AT C5. IT WAS ALSO STATED THAT THE INS WAS TILTED IN THE POCKET. THE PT WAS CONSIDERING THE OPTION OF ANOTHER SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MDT PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention LOT # NJH719506H| IMPLANTED:| PROGRAMMER MODEL 37742, LOT # NJD061671N| ACCESSORY: MODEL 37752, LOT # NKA141615N| EXPLANTED:| EXTENSION: MODEL 37081, LOT # NJB047780V| LEAD: MODEL 39286-65, LOT # V364358038| EXPLANTED:| ACCESSORY: MODEL 37752, LOT # NKA120353N| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 39565-30, LOT # N187135004| EXPLANTED:| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 37711,| PROGRAMMER: MODEL 37743, LOT # NKE145815N| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 37081, LOT # NJB048572V