BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 404204 · Received June 26, 2002

    Report

    Report Number
    404204
    Event Type
    Injury
    Date Received
    June 26, 2002
    Date of Event
    April 16, 2002
    Report Date
    May 7, 2002
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    04/2002 - ROUTINE PACEMAKER CLINIC CHECK REVEALED BIPOLAR VENTRICULAR LEAD IMPEDANCE OF 186-187 OHMS, CHARGED FROM PAST LEAD IMPEDANCES OF APPROX 439 OHMS, CONSISTENT WITH EARLY SIGNS OF VENTRICULAR LEAD INSULATION FAILURE. ELEVEN DAYS LATER, PACEMAKER LEAD AND GENERATOR REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC DUAL CHAMBER PERMANENT PACEMAKER DXY MEDTRONIC, INC. 7074 *
    2 MEDTRONIC 4004 VENTRICULAR LEAD DTB MEDTRONIC, INC. 4004 *

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention