BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2950908 · Received February 8, 2013

    Report

    Report Number
    3004209178-2013-01499
    Event Type
    Malfunction
    Date Received
    February 8, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 21, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37085-40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: EXTENSION: PRODUCT ID 3387S-40, LOT# V595266, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A "POWER-ON-RESET" (POR) CONDITION AFTER RECEIVING RADIATION TREATMENT. LATER THAT DAY IT WAS REPORTED THAT THERE WAS A "CALL YOUR DOCTOR" ICON DISPLAYED ON THE PROGRAMMER AND A POR CONDITION AFTER RADIATION TREATMENT ON (B)(6) 2013. THE MEDTRONIC REPRESENTATIVE WAS GOING TO MEET WITH THE PATIENT AT THE CLINIC TO CLEAR THE POR CONDITION. IT WAS UNKNOWN WHERE THE PATIENT WAS RECEIVING RADIATION AND IF IT WAS CLOSE TO THE IMPLANTABLE NEUROSTIMULATOR (INS). TEN DAYS LATER IT WAS REPORTED THAT THE ISSUE HAD BEEN RESOLVED BY TURNING THE INS ON WITH THE CLINICIAN PROGRAMMER. NO INTERVENTION WAS NECESSARY. IT WAS STATED THAT THE PATIENT WAS "DOING WELL." NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    54432 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR