BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FREEZOR XTRA

    MDR report key: 3121579 · Received May 20, 2013

    Report

    Report Number
    3121579
    Event Type
    Malfunction
    Date Received
    May 20, 2013
    Date of Event
    March 28, 2013
    Report Date
    May 20, 2013
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    LPB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    BROKEN CATHETER, ELECTRICAL SIGNALS 1-2 DO NOT WORK WHEN DEFLECTING CATHETER.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?CARDIAC ABLATION.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222893 FREEZOR XTRA CARDIAC ABLATION PERCUTANEOUS CATHETER LPB MEDTRONIC, INC. * 74774

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR