BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOCOR STENTED PORCINE HEART VALVE

    MDR report key: 1180476 · Received September 26, 2008

    Report

    Report Number
    3001743903-2008-00050
    Event Type
    Injury
    Date Received
    September 26, 2008
    Date of Event
    September 22, 2008
    Report Date
    September 26, 2008
    Manufacturer
    ST JUDE MEDICAL BRASIL LTDA.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT FAINTED WHILE ON THE TREADMILL DURING A STRESS TEST. IT WAS DETERMINED THE PT HAD A HIGH GRADIENT OF 85 MMHG AND THE LEAFLETS WERE STENOTIC. THE VALVE WAS EXPLANTED. ADDITIONAL INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOCOR STENTED PORCINE HEART VALVE STENTED TISSUE VALVE LWR ST JUDE MEDICAL BRASIL LTDA. B10-27A-00

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R