BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 2714404 · Received August 24, 2012

    Report

    Report Number
    3004209178-2012-07368
    Event Type
    Malfunction
    Date Received
    August 24, 2012
    Report Date
    July 27, 2012
    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). LEAD: MODEL 3387S-40, LOT# V961943, IMPLANTED: (B)(6) 2012, EXPLANTED: NA; EXTENSION: MODEL 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: NA

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS UNABLE TO TURN STIMULATION ON. THE DISPLAY SHOWED A "CALL YOUR DOCTOR" ICON. AN OUT-OF-REGULATION CONDITION WAS REPORTED. IT WAS NOTED THAT THE PATIENT HAD BEEN IMPLANTED WITH A PACEMAKER THE DAYS BEFORE, AND THAT THE PACEMAKER WAS FUNCTIONING AS DESIGNED. THE PATIENT'S NEUROSTIMULATOR WAS CHECKED AND ALL WAS WELL. IT WAS REPORTED THAT THE PROBLEM WAS THAT THE PACEMAKER TELEMETRY WAND HAD BEEN OVER THE PATIENT'S PACEMAKER AND HAD BEEN INTERFERING WITH THE PATIENT'S DBS PROGRAMMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1