BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE ULTRA

    MDR report key: 3872386 · Received June 13, 2014

    Report

    Report Number
    3004209178-2014-11567
    Event Type
    Malfunction
    Date Received
    June 13, 2014
    Report Date
    May 23, 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
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD; PRODUCT ID 37743, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 37752, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 3777-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT RAISED HIS ARM UP ONE TIME AND IT SHOCKED THE HECK OUT OF HIM. THE FIRST TIME THIS HAPPENED WAS IN (B)(6). THE PATIENT GOT OUT OF HIS VEHICLE AND HE FELT LIKE HE GOT STUNG BY SOMETHING. THE STING WAS RIGHT AROUND THE INS AREA. HE HAD ANOTHER STING THE SAME DAY. THE PATIENT WENT IN THE HOUSE AND TOOK OFF HIS CLOTHES BECAUSE IT FELT LIKE SOMETHING HAD STUNG HIM. THEN REALIZED IT MAY BE COMING FROM THE INS. THREE DAYS LATER THE PATIENT STARTED CHARGING AND HE STARTED GETTING WARM ON HIS BACK. THE PATIENT WAS HAVING TROUBLE GETTING ¿DIALED IN¿ AND COULD NOT GET THE COUPLING BOXES. USUALLY THE PATIENT CAN GET 6 ANYTIME. THE PATIENT WAS ABLE TO FINALLY GET 4 AND THEN IT STARTED FEELING HOT SO HE STOPPED AND THEN HE WAS NOT ABLE TO COMMUNICATE WITH THE PATIENT PROGRAMMER (PP) EITHER. THE PATIENT WAS NOT ABLE TO MAKE ADJUSTMENTS. THE PATIENT DID NOT HAVE A CURRENT DOCTOR. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    349409 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 00053 YR