BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM

    MDR report key: 16133 · Received September 15, 1994

    Report

    Report Number
    MW1003363
    Event Type
    Malfunction
    Date Received
    September 15, 1994
    Date of Event
    July 27, 1994
    Report Date
    September 5, 1994
    Manufacturer
    INTERMEDICS, INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    THE PT'S EKG WAS RECORDED DURING AN EEG EXAM INCORPORATING PHOTO STIMULATION. THE QRS INCREASED WITH THE INCREASE IN PHOTO-STIM FREQUENCY. PACING MARKS ON THE R WAVE SEEMED TO BE PRESENT. THE OPERATOR STOPPED THE EEG TEST. THE PT WAS NOT HARMED, AND WAS REFERRED TO HIS CARDIOLOGIST. THE EEG MACHINE WAS TESTED AND OPERATED NORMALLY. EMF WAS NOT TESTED DUE TO COST CONSIDERATIONS. THE EEG WAS REPEATED WITHOUT INCIDENT A MONTH LATER. MFR SUSPECTED THE PACEMAKER WAS IN A NOISE OR BACK-UP MODE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM Implant INTERNAL DEMAND PACEMAKER DXY INTERMEDICS, INC. 254-20

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other