BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRUFECTA VALVE

    MDR report key: 2901199 · Received January 4, 2013

    Report

    Report Number
    3007113487-2013-00001
    Event Type
    Injury
    Date Received
    January 4, 2013
    Date of Event
    November 27, 2012
    Report Date
    December 19, 2012
    Manufacturer
    ST. JUDE MEDICAL, INC. (CS-WOODRIDGE)
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THIS VALVE WAS EXPLANTED DUE TO A CANDIDA FUNGUS INFECTION OF THE AORTIC ROOT AND VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4733 TRUFECTA VALVE TISSUE HEART VALVE LWQ ST. JUDE MEDICAL, INC. (CS-WOODRIDGE) TF-25A

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R