BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM EPIC STENTED PORCINE HEART VALVE

    MDR report key: 2181204 · Received July 22, 2011

    Report

    Report Number
    3001743903-2011-00051
    Event Type
    Injury
    Date Received
    July 22, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 22, 2011
    Manufacturer
    ST JUDE MEDICAL BRASIL LTDA.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH SHORTNESS OF BREATH AND ANGINA AND WAS FOUND TO HAVE LEAFLET PROLAPSE, RESTRICTED LEAFLET EXCURSION, AND 1+ AORTIC REGURGITATION. THE VALVE WAS EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 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 66 YR Hospitalization| R