BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 1120763 · Received August 15, 2008

    Report

    Report Number
    3004209178-2008-04941
    Event Type
    Injury
    Date Received
    August 15, 2008
    Date of Event
    June 1, 2008
    Report Date
    July 18, 2008
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT FELT NO STIMULATION SENSATION IN HIS AREA OF PARESTHESIA SINCE IMPLANT, EVEN WHEN THE DEVICE WAS PROGRAMMED TO ITS HIGHEST LEVEL. THE STIMULATOR 'STOPPED WORKING'. THERE WAS NO KNOWN INCIDENT OR ACCIDENT RELATED TO THE COMPLAINT. THE PT REPORTED HE HAD ATTEMPTED TO CONTACT THE FIELD REP MULTIPLE TIMES. THE PT WAS TRAVELING AND THE FIELD REP IN HIS AREA WAS CONTACTED. THE PT MET WITH THE FIELD REP APPROX 3 DAYS AFTER THE COMPLAINT. THE SYS HADN'T BEEN CHECKED SINCE THE DAY OF IMPLANT, APPROX ONE MONTH EARLIER. THE PT FELT NO STIMULATION WITH THE AMPLITUDE PROGRAMMED TO 10.5 VOLTS. OF ELECTRODES 0-7, FIVE HAD IMPEDANCES GREATER THAN 10,000 OHMS. ON ELECTRODES 8-15, FOUR HAD IMPEDANCES GREATER THAN 10,000 OHMS. THE DEVICE WAS PROGRAMMED USING THE AVAILABLE ELECTRODES. THE PT COULD FEEL A LITTLE STIMULATION IN HIS LEGS AT 5 VOLTS AFTERWARD. HE REPORTED THAT ONLY 2 OF SEVEN ELECTRODES WORK FOR HIS LEGS AND 0 ELECTRODES WORK FOR HIS BACK. THE PT HAD BETTER CONTROL OF HIS STIMULATION AFTER REPROGRAMMING. THE PT WAS SEEN AGAIN BY A FIELD REP ABOUT 2 WEEKS LATER AND REPORTED NO STIMULATION IN THE SUBCUTANEOUS REGION. IMPEDANCES ON THE SUBCUTANEOUS LEAD WERE NOT CHECKED. THE PULSE WIDTH WAS LOWERED, THE AMPLITUDE WAS INCREASED AND THE TOP ELECTRODES WERE DEACTIVATED. THE REP ATTEMPTED TO CORRECT ABSENT STIMULATION IN ONE OF THE PT'S LEGS. THE PT REPORTED GOOD STIMULATION AFTERWARD. MOST OF THE PT'S PAIN WAS IN HIS LOWER BACK WHICH 'FELT GOOD' WHEN HE LEFT. THE PT WAS VERY SATISFIED WHEN HE LEFT THE OFFICE. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SUBMITTED IF ADD'L INFO BECOMES AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention LEAD MODEL 3777 LOT # V092216034 IMPLANTED| EXPLANTED| EXTENSION MODEL 37081 LOT # NJB036208V IMPLANTED| EXPLANTED| LEAD MODEL 3777 LOT # V106103030 IMPLANTED| EXPLANTED| EXPLANTED| EXTENSION MODEL 37081 LOT # NJB036207V IMPLANTED