BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC QUIK-COMBO

    MDR report key: 2142478 · Received June 22, 2011

    Report

    Report Number
    MW5021122
    Event Type
    Malfunction
    Date Received
    June 22, 2011
    Date of Event
    June 9, 2011
    Report Date
    June 22, 2011
    Manufacturer
    MEDTRONIC PHYSIO-CONTROL
    Product Code
    MKJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING AN ELECTROPHYSIOLOGY STUDY WITH ARRHYTHMIA INDUCTION, MAPPING AND RADIOFREQUENCY ABLATION PROCEDURE. IN ANTICIPATION OF THE ARRHYTHMIA INDUCTION, THE PATIENT HAD DEFIBRILLATOR PADS APPLIED. DURING THE ABLATION PROCEDURE, THE PATIENT REQUIRED AN EXTERNAL SHOCK FROM THE DEFIBRILLATOR. DURING THE ATTEMPTED DELIVERY OF THE SHOCK, AN ELECTRICAL ARC WAS HEARD AND NO SHOCK WAS DELIVERED. THE DEFIBRILLATOR PADS WERE INSPECTED AND THE LATERALLY PLACED PAD HAD A LOOSE WIRE THAT HAD DETACHED FROM THE CHEST PAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC QUIK-COMBO PACING/DEFIBRILLATOR PADS MKJ MEDTRONIC PHYSIO-CONTROL 2013-08-28 10415

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR