BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 3904746 · Received May 14, 2014

    Report

    Report Number
    3904746
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    MICROPACE PTY. LTD.
    Product Code
    JOQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS SCHEDULED FOR AN ELECTROPHYSIOLOGY STUDY / ATRIAL FIBRILLATION RADIOFREQUENCY ABLATION. THE MICRO-PACE SYSTEM WOULD NOT BOOT UP SO THE CASE HAD TO BE CANCELLED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289434 * GENERATOR, PULSE, PACEMAKER, EXTERNAL PROGRAMMABLE JOQ MICROPACE PTY. LTD. MP3008 025, SN/754

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR