BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3033727 · Received April 3, 2013

    Report

    Report Number
    9614453-2013-00582
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 15, 2013
    Report Date
    September 11, 2013
    Manufacturer
    IPG MFG SWITZERLAND
    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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION REPORTED THAT THE PATIENT WAS SEEN SHORTLY AFTER THE INCIDENT OCCURRED WHERE IT WAS FOUND THAT THE IMPLANTABLE NEUROSTIMULAOR (INS) WAS FINE AND THAT IMPEDANCE VALUES WERE WITHIN NORMAL LIMITS. THE PATIENT WAS REPORTED AS DOING "GREAT MOTORICALLY AND FUNCTIONALLY".

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WENT THROUGH COURTHOUSE SECURITY AND HAD SLOWER SPEECH AND WAS CHOKING MORE. THE PATIENT COULD STILL SNAP THEIR FINGERS, BUT WAS HAVING MORE ISSUES WITH FINGER TAPS. THE PATIENT WAS TO FOLLOW UP WITH THEIR HEALTH CARE PROVIDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136548 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 37601

    Patients

    Seq Age Sex Outcome Treatment
    1