BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONICS

    MDR report key: 519935 · Received March 24, 2004

    Report

    Report Number
    MW1031664
    Event Type
    Malfunction
    Date Received
    March 24, 2004
    Date of Event
    March 9, 2004
    Report Date
    March 24, 2004
    Manufacturer
    MEDTRONICS
    Product Code
    LDD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT ARRIVED TO ROOM FOLLOWING OPEN HEART SURGERY. THE TEMPORARY PACEMAKER CUT OFF AUTOMATICALLY. MANUALLY RESTARTED BY RN. PACEMAKER WAS IN DDI MODE AT 50. WITHIN 2 1/2 - 3 HOURS THE PACEMAKER CUT OFF AGAIN. PACEMAKER WAS IMMEDIATELY CHANGED. NO APPARENT INJURY TO PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONICS TEMP. PACEMAKER LDD MEDTRONICS 5388 *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other