BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM EPIC STENTED PORCINE HEART VALVE

    MDR report key: 2970961 · Received February 15, 2013

    Report

    Report Number
    3001743903-2013-00006
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    February 5, 2012
    Report Date
    February 5, 2013
    Manufacturer
    ST JUDE MEDICAL BRASIL LTDA
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED TO SJM INDICATED THE VALVE WAS EXPLANTED DUE TO THROMBUS RESULTING IN STENOSIS. ANOTHER MFR'S 23MM VALVE WAS IMPLANTED AND THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69410 SJM EPIC STENTED PORCINE HEART VALVE STENTED TISSUE VALVE LWR ST JUDE MEDICAL BRASIL LTDA E100-23A-00

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R