BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EV4542

    MDR report key: 621607 · Received July 7, 2005

    Report

    Report Number
    621607
    Event Type
    Malfunction
    Date Received
    July 7, 2005
    Date of Event
    May 23, 2005
    Report Date
    July 7, 2005
    Manufacturer
    PACE MEDICAL INC
    Product Code
    DRO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    DURING CODE SITUATION, NURSE TURNED OFF PACEMAKER TO DETERMINE BASIC RATE. WHEN NURSE ATTEMPTED TO TURN PACER BACK ON, PACER WOULD NOT FUNCTION. FOLLOW UP REVEALS THIS PROBLEM WAS ABLE TO BE DUPLICATED. THE DEVICE DID NOT TOLERATE BEING MOMENTARILY SWITCHED OFF AND ON. IF IT WAS ALLOWED TO SIT FOR A WHILE IN THE OFF MODE, IT WOULD RETURN TO NORMAL OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EV4542 DEMAND PACEMAKER DRO PACE MEDICAL INC EV4542 NONE

    Patients

    Seq Age Sex Outcome Treatment
    1 *