BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POLY-TAC PACING DEFIBRILLATION ELECTRODES

    MDR report key: 36943 · Received September 6, 1996

    Report

    Report Number
    MW1009886
    Event Type
    Malfunction
    Date Received
    September 6, 1996
    Date of Event
    August 24, 1996
    Report Date
    August 27, 1996
    Manufacturer
    PADECO, INC.
    Product Code
    LWQ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WHILE USING A MONITOR/DEFIBRILLATOR/PACER ON THIS PT IN THE EMERGENCY DEPT, PACER FAILED TO WORK PROPERLY. PACER WAS USED WITH ELECTRODES. PACER ALARMED "PADS NOT PRESENT" AFTER 1 OR 2 PACE PULSES. NEW PADS WERE APPLIED WITH SAME NEGATIVE RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 POLY-TAC PACING DEFIBRILLATION ELECTRODES Implant PACING DEFIBRILLATION ELECTRODES LWQ PADECO, INC. * Y042596

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR