BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM BIOCOR STENTED PORCINE VALVE W/ FLEXFIT SYSTEM

    MDR report key: 3012561 · Received March 15, 2013

    Report

    Report Number
    3001743903-2013-00012
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    February 26, 2013
    Report Date
    February 26, 2013
    Manufacturer
    ST. JUDE MEDICAL BRASIL LTDA.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EC
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE VALVE WAS EXPLANTED DUE TO ELEVATED GRADIENT AND CALCIFICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110095 SJM BIOCOR STENTED PORCINE VALVE W/ FLEXFIT SYSTEM STENTED TISSUE VALVE LWR ST. JUDE MEDICAL BRASIL LTDA. B100-23A

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R