BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAESTRO CARDIAC ABLATION SYSTEM

    MDR report key: 1232744 · Received November 14, 2008

    Report

    Report Number
    2953184-2008-00048
    Event Type
    Malfunction
    Date Received
    November 14, 2008
    Date of Event
    October 15, 2008
    Report Date
    October 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC EP TECH. INC.
    Product Code
    LPB
    PMA / PMN Number
    P980003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS CURRENTLY BEING EVALUATED. F/U REPORTS WILL BE SUBMITTED ONCE INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    DURING PREPARATION, SMOKE WAS SEEN COMING OUT OF THE CONSOLE. NO PT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MAESTRO CARDIAC ABLATION SYSTEM LPB BOSTON SCIENTIFIC EP TECH. INC. M00421000TCR0

    Patients

    Seq Age Sex Outcome Treatment
    1 Other