BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC, INC.

    MDR report key: 477917 · Received August 8, 2003

    Report

    Report Number
    MW1029286
    Event Type
    Malfunction
    Date Received
    August 8, 2003
    Date of Event
    June 25, 2003
    Report Date
    August 8, 2003
    Manufacturer
    MEDTRONIC, INC.
    Product Code
    DTE
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    KS, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT'S MONITOR ALARMED AND PT FOUND IN ASYSTOLE. MEDTRONIC TEMPORARY PACEMAKER WAS FOUND OFF. NURSE PUSHED THE "ON" BUTTON AND THE PACEMAKER DID TURN ON AND BEGAN PACING. PT HAD PACED RHYTHM WITH PULSE AND WAS AWAKE AND MOVING AFTER PACE RESUMED. STAFF TOOK PACEMAKER OUT OF SERVICE AND REPLACED WITH ANOTHER PACEMAKER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC, INC. TEMPORARY PACEMAKER DTE MEDTRONIC, INC. 5388 *

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR