BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3922296 · Received July 9, 2014

    Report

    Report Number
    3007566237-2014-01901
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Report Date
    June 17, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_EXT, LOT# UNKNOWN, PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ¿YEARS AGO¿ THE PATIENT WAS FLYING ¿TO WEST TO EAST COST¿ AND HE HAD A POWER ON RESET (POR). THE PATIENT WAS REFERRED TO THE REPORTER¿S OFFICE BECAUSE HE WAS DOING ¿TERRIBLE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    400243 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37612

    Patients

    Seq Age Sex Outcome Treatment
    1