BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPREME QUAD CRD-2

    MDR report key: 3911917 · Received June 30, 2014

    Report

    Report Number
    3911917
    Event Type
    Malfunction
    Date Received
    June 30, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 30, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US

    Narratives

    Description of Event or Problem · 1

    DR PLACES CATHETER IN PATIENT AND IT WOULD NOT WORK, REMOVED FROM PATIENT. NO HARM. CATHETER WAS PLUGGED IN BUT THERE WAS NO SIGNAL, THEY TRIED DIFFERENT CHANNELS BUT STILL NO SIGNAL. ANOTHER DEVICE WAS OBTAINED AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    378903 SUPREME QUAD CRD-2 CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF ST. JUDE MEDICAL, INC. 401860 4528264

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR