BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOCOR STENTED PORCINE HEART VALVE

    MDR report key: 1180474 · Received September 26, 2008

    Report

    Report Number
    3001743903-2008-00048
    Event Type
    Injury
    Date Received
    September 26, 2008
    Date of Event
    September 23, 2008
    Report Date
    September 26, 2008
    Manufacturer
    ST JUDE MEDICAL BRASIL LTDA.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT PRESENTED WITH RESPIRATORY DISTRESS. AN ECHO WAS PERFORMED AND THE PT SHOWED A GRADIENT OF 25MMHG, A SECOND ECHO WAS PERFORMED AND SHOWED A GRADIENT OF 37MMHG. THE VALVE WAS EXPLANTED AND REPLACED WITH ANOTHER DEVICE (MODEL AND SERIAL NUMBER UNK). 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. B10-29M-00

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R