BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    QUANTUM II

    MDR report key: 49831 · Received November 7, 1996

    Report

    Report Number
    1640319-1996-00508
    Event Type
    Malfunction
    Date Received
    November 7, 1996
    Date of Event
    September 10, 1996
    Manufacturer
    INTERMEDICS, INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE RPORTER INDICATED THAT THERE WAS NO CONTACT WITH THE PROGRAMMER 522-06-08736 AND 531-49L-200184, SERIAL NUMBER RECEIVED FROM THE DEVICE IS NOT RECOGNIZED AS VALID. THERE WERE NO SPIKES RECOGNIZED WITH MAGNET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM II Implant IMPLANTABLE PACEMAKER DXY INTERMEDICS, INC. 254-30 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 *