BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC, INC

    MDR report key: 280409 · Received June 2, 2000

    Report

    Report Number
    280409
    Event Type
    Injury
    Date Received
    June 2, 2000
    Date of Event
    March 6, 2000
    Report Date
    May 31, 2000
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING A PACEMAKER FAILURE (DUE TO END OF LIFE OF PULSE GENERATOR) IT WAS DISCOVERED THAT INSULATION BREAKS HAD OCCURRED IN BOTH ATRIAL AND VENTRICULAR ELECTRODES. BOTH WERE CAPPED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC, INC ARTERIAL LEAD DTB MEDTRONIC, INC. A-4058M; *
    2 MEDTRONIC, INC VENTRICAL LEAD DTB MEDTRONIC, INC. V-5024 *

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening| R PULSE GENERATOR, MODEL 7084, ELITE II.