BEUDAMED
    FDA Adverse Event Other Summary report: N

    ST. JUDE MEDICAL

    MDR report key: 754872 · Received August 22, 2006

    Report

    Report Number
    754872
    Event Type
    Other
    Date Received
    August 22, 2006
    Date of Event
    August 18, 2006
    Report Date
    August 21, 2006
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    LWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ND, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MITRAL VALVE REPLACEMENT WITH ST. JUDE 25MM MITRAL VALVE, WHICH ON ECHOCARDIOGRAM WAS MALFUNCTIONING, SEVERE MITRAL VALVE REGURGITATION. THE VALVE LEAFLETS WERE CLOSED. HOWEVER, ONE OF THE LEAFLETS WAS STICKY. REINSTITUTION OF CARDIOPULMONARY BYPASS AND REPLACEMENT OF MITRAL VALVE. ECHOCARDIOGRAM POST IMPLANTATION SHOWS NO PARAVALVULAR LEAK AND NO MITRAL VALVE REGURGITATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE MEDICAL MECHANICAL HEART VALVE 25MM LWQ ST. JUDE MEDICAL, INC. 25MJ-501 *

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other