BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMAX 540

    MDR report key: 3019839 · Received February 20, 2013

    Report

    Report Number
    3019839
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    February 5, 2013
    Report Date
    February 20, 2013
    Manufacturer
    BIOTRONIK, INC.
    Product Code
    LWS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US

    Narratives

    Description of Event or Problem · 1

    UPON EXTRACTION OF PACEMAKER LEAD MD NOTICED PACING WIRE PROTRUDING FROM INSULATION. REASON FOR INVESTIGATION IS THAT MD IS CONCERNED THAT THE LEAD INSULATION WAS DEFECTIVE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?REMOVAL OF DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75052 LUMAX 540 IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS BIOTRONIK, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR PACEMAKER