BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALO XP

    MDR report key: 3030066 · Received March 27, 2013

    Report

    Report Number
    3030066
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    February 26, 2013
    Report Date
    March 27, 2013
    Manufacturer
    BIOSENSE WEBSTER, INC.
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    PER THE CARDIAC TECHNICIAN "AFTER PLACING HALO CATHETER INTO RIGHT ATRIUM MULTIPLE ELECTRODES WERE NOT DISPLAYING AND/OR NOISY."WHAT WAS THE ORIGINAL INTENDED PROCEDURE?CARDIAC ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126020 HALO XP CATHETER, EP DRF BIOSENSE WEBSTER, INC. * 15770519L

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR UNKNOWN AT TIME OF REPORT