BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 53134 · Received August 22, 1996

    Report

    Report Number
    53134
    Event Type
    Malfunction
    Date Received
    August 22, 1996
    Date of Event
    January 10, 1996
    Report Date
    January 24, 1996
    Manufacturer
    MEDTRONIC PRODUCT INFO
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PACEMAKER PLACED IN 1987 DUE TO THIRD DEGREE HEART BLOCK. DUE TO LEAD FAILURE, LEAD REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC Implant PERMANENT PACEMAKER DXY MEDTRONIC PRODUCT INFO 4012-58 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Other