BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 519943 · Received March 25, 2004

    Report

    Report Number
    MW1031674
    Event Type
    Malfunction
    Date Received
    March 25, 2004
    Report Date
    March 15, 2004
    Manufacturer
    MEDTRONIC
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    INSULATION BREAK DOWN IN LEAD (V LEAD). CAUSING DECREASED TRENDING IMPEDANCE. LEAD NOT EXPLANTED. CAPPED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC VENTRICULAR LEAD DTB MEDTRONIC 4024-52 *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other