BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ATS MEDICAL, INC.

    MDR report key: 523750 · Received February 16, 2004

    Report

    Report Number
    2134151-2004-00001
    Event Type
    Malfunction
    Date Received
    February 16, 2004
    Date of Event
    December 13, 2003
    Report Date
    February 16, 2004
    Manufacturer
    ATS MEDICAL, INC.
    Product Code
    LWQ
    Removal / Correction Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE SURGEON IMPLANTED A 18MM VALVE IN THE REVERSED POSITION. THE SURGEON NOTICED THE VENTRICLE ENLARGING AND IMMEDIATELY RESUMED BYPASS. AFTER RE-OPENING, THE SURGEON OBSERVED THAT THE VALVE WAS REVERSED. THE SURGEON EXCISED THE VALVE AND RE-IMPLANTED THE SAME VALVE. THE PT IS RECOVERING NORMAL. THE PT HAS BEEN DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATS MEDICAL, INC. MECHANICAL HEART VALVE LWQ ATS MEDICAL, INC. 501DA18 302343

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Life Threatening| R