BEUDAMED
    FDA Adverse Event Death Summary report: N

    ST. JUDE MECHANICAL HEART VALVE

    MDR report key: 1595305 · Received February 2, 2010

    Report

    Report Number
    1595305
    Event Type
    Death
    Date Received
    February 2, 2010
    Date of Event
    October 13, 2009
    Report Date
    October 21, 2009
    Manufacturer
    ST. JUDE MED, INC.
    Product Code
    LWQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD ST. JUDE MECHANICAL HEART VALVE PLACED ON (B) (6) 2009. VALVE WAS REMOVED ON (B) (6) 2009 AND REPLACED WITH AN AORTIC VALVE ST. JUDE MECHANICAL 21MM. PT CODED AND EXPIRED ON (B) (6) 2009.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE MECHANICAL HEART VALVE AORTIC VALVE LWQ ST. JUDE MED, INC. IHA6FN-756 83558138

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death| R