BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC

    MDR report key: 156683 · Received January 19, 1998

    Report

    Report Number
    156683
    Event Type
    Injury
    Date Received
    January 19, 1998
    Date of Event
    September 25, 1997
    Report Date
    January 19, 1998
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PACEMAKER TELEMETRY REVEALED NO ACTIVITY IN PT'S PACEMAKER ATRIAL LEAD, COINCIDING WITH DECREASED EXERCISE TOLERANCE AND LETHARGY. PT ADMITTED FOR PACEMAKER EVALUATION AND CHEST X-RAY DEMONSTRATED FRACTURE OF ATRIAL LEAD. PACEMAKER REPLACED 9/25/1997.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC Implant PACEMAKER DXY MEDTRONIC, INC. SYMBIOS DDD *

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention