BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2963760 · Received February 15, 2013

    Report

    Report Number
    3004209178-2013-02702
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Report Date
    January 31, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE EXTENSION; PRODUCT ID 7482A51, SERIAL # (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE EXTENSION; PRODUCT ID 3389S-40, LOT # V015727, IMPLANTED: (B)(6) 2007; PRODUCT TYPE LEAD; PRODUCT ID 3389040, LOT # V008978, IMPLANTED: (B)(6) 2010, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "ABOUT FOUR TIMES A YEAR" THE PATIENT'S DEVICE "INEXPLICABLY" WENT OFF. THE REPORTER STATED THAT WHEN THE DEVICE WENT OFF THE PATIENT REALIZED IT AFTER ABOUT A DAY. IT WAS REPORTED THAT THE DEVICE WAS CHECKED SEVERAL TIMES A WEEK TO SEE IF IT WAS STILL ON BECAUSE SOME "POWER SOURCE OR GOING THROUGH A MAGNETIC DOOR" OR "SOMETHING" MADE IT GO OFF PERIODICALLY. THE REPORTER STATED THAT THE PATIENT ALSO HAD VARIOUS KINDS OF THERAPY, INCLUDING ACUPUNCTURE THERAPY WITH AN ELECTRIC DEVICE. IT WAS NOTED THAT THE DEVICE WAS USUALLY TURNED OFF BEFORE THE THERAPY AND TURNED BACK ON AFTER IT WAS DONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. SEE MFR REPORT #3004209178-2013-02701. IT WAS UNCLEAR WHICH DEVICE WAS INVOLVED IN THE EVENT OR IF BOTH DEVICES WERE INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66684 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1