BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL CHAMBER TEMP PACER

    MDR report key: 1012556 · Received February 20, 2008

    Report

    Report Number
    1012556
    Event Type
    Malfunction
    Date Received
    February 20, 2008
    Date of Event
    January 7, 2008
    Report Date
    February 20, 2008
    Manufacturer
    MEDTRONIC, INC. CARDIAC RHYTHM MANAGEMENT
    Product Code
    DTE
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC TEMPORARY PACER MODEL SHUT OFF WITH NO BATTERY WARNING SYMBOL. CCU CHARGE RN BROUGHT PACER TO ED TO ASSIST WITH INSERTION WITH CARDIOLOGIST. PACER WIRE INSERTED AND CONNECTED TO GENERATOR. PATIENT 100% PACED. RN NOTED CESSATION OF PACING AFTER A FEW MINUTES. CHECKED PACER AND IT WAS OFF. SHE ATTEMPTED TO TURN IT BACK ON AND LIGHTS AT TOP BLINKED, AND PACER WOULD NOT TURN ON. BACK UP PACER AVAILABLE AND RN SWITCHED IT OVER (LESS THAN ONE MINUTE) AND PACING RESUMED. UNDERLYING RHYTHM WAS CHB (COMPLETE HEART BLOCK) RATE LESS THAN 20/MIN. PATIENT CONSCIOUS THROUGHOUT EPISODE. RN CHECKED PACER AFTER AND NO LOW BATTERY DISPLAY. REGARDLESS, SHE CHANGED THE BATTERY AND STILL COULD NOT GET PACER TO TURN ON. PACER GIVEN TO CLINICAL EDUCATOR UPON RN'S RETURN TO CCU AND PACER SEEMED TO TURN ON OKAY. EQUIPMENT TAGGED AND REFERENCED WITH IR # AND GIVEN TO CLINICAL ENGINEERING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DUAL CHAMBER TEMP PACER PACEMAKER, TEMPORARY DTE MEDTRONIC, INC. CARDIAC RHYTHM MANAGEMENT 5388 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *