BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRONUS FLOPPY GUIDEWIRE

    MDR report key: 514039 · Received February 23, 2004

    Report

    Report Number
    MW1031301
    Event Type
    Malfunction
    Date Received
    February 23, 2004
    Date of Event
    January 26, 2004
    Report Date
    February 19, 2004
    Manufacturer
    STEREOTAXIS, INC.
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    STEREOTAXIS GUIDE WIRE LOCKED IN BI-V ICD LEAD. PHYSICIAN ABLE TO REMOVE WIRE WITHOUT ADVERSE OUTCOME. WIRE RETURNED TO STEREOTAXIS FOR EVALUATION. TO DATE NO RESPONSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRONUS FLOPPY GUIDEWIRE GUIDEWIRE DQX STEREOTAXIS, INC. * 0308-4057

    Patients

    Seq Age Sex Outcome Treatment
    1 *