BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3232581 · Received July 18, 2013

    Report

    Report Number
    3007566237-2013-02386
    Event Type
    Injury
    Date Received
    July 18, 2013
    Report Date
    June 26, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT CHARGING OF THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS DIFFICULT. THERE WERE ONLY BLANK BOXES, AND SOMETIMES TWO BOXES COULD BE SEEN IN THE EFFICIENCY DISPLAY. IT WAS STATED THAT "MAYBE THE INS WILL BE IMPLANTED CLOSER TO THE SKIN". IT WAS LATER REPORTED THAT THE INS WAS FLIPPED. THE NEUROSURGEON "FLIPPED IT IN THE RIGHT POSITION" AND THEN RECHARGING WAS EASY. IT WAS STATED THAT THE PATIENT WAS "OK".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333686 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00039 YR Required Intervention