BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3231503 · Received July 17, 2013

    Report

    Report Number
    3007566237-2013-02375
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Report Date
    April 3, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECENTLY DEVELOPED DYSKINESIA AND A DEVICE CHECK WAS CONDUCTED. AN IMPEDANCE VARIATION WAS REVEALED. THE DEVICE, WHICH WAS SET ON CONSTANT VOLTAGE MODE, HAD A CURRENT INCREASE FROM 1.2 ML TO 1.7 MA. THIS WAS CONSIDERED TO BE THE CAUSE OF THE DYSKINESIA. AFTER THE IMPLANTABLE PULSE GENERATOR WAS CHANGED TO CONSTANT CURRENT MODE, THE SITUATION BECAME STABLE. THE CAUSE OF THIS VARIATION ONE YEAR AFTER IMPLANT WAS UNKNOWN. IT WAS NOTED THAT SOON AFTER THE OPERATION THE PATIENT HAD EXPERIENCED AN IMPEDANCE VARIATION ALSO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330689 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37603

    Patients

    Seq Age Sex Outcome Treatment
    1