BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOCOR STENTED PORCINE HEART VALVE

    MDR report key: 1893128 · Received October 29, 2010

    Report

    Report Number
    3001743903-2010-00086
    Event Type
    Injury
    Date Received
    October 29, 2010
    Date of Event
    October 13, 2010
    Report Date
    October 29, 2010
    Manufacturer
    ST JUDE MEDICAL BRASIL LTDA.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE VALVE WAS EXPLANTED AND REPLACED WITH ANOTHER MFR'S VALVE. ADD'L 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. 10-25A-00

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R