BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC PACER

    MDR report key: 416450 · Received September 12, 2002

    Report

    Report Number
    416450
    Event Type
    Malfunction
    Date Received
    September 12, 2002
    Date of Event
    August 14, 2002
    Report Date
    September 10, 2002
    Manufacturer
    *
    Product Code
    DXY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PT WAS ADMITTED TO THE HOSPITAL BECAUSE OF WEAKNESS AND FATIGUE. WHILE ON THE FLOOR (TELEMETRY), THE PT CODED DUE TO PACER NON-CAPTURE. THE PT WAS QUICKLY RESUSCITATED AND MOVED TO ICU. THE PACER CONTIUED TO FUNCTION WELL UNTIL THE EARLY MORNING, WHEN IT WAS NOTED THAT RHYTHM SHOWED ONLY SPIKES OF THE PACER. CAUSE OF DEATH WAS PACER FAILURE DUE TO AN EXTREMELY HIGH POTASSIUM LEVEL DUE TO RENAL FAILURE. IT WAS NOT FELT THAT THE PACER MALFUNCTIONED. THE PT HAD A HISTORY OF RENAL FAILURE, CONGESTIVE HEART FAILURE, AND EXTENSIVE MI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC PACER PACER DXY * 8040 *

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR