BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM EPIC VALVE

    MDR report key: 2000951 · Received February 18, 2011

    Report

    Report Number
    3001743903-2011-00006
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    January 6, 2011
    Report Date
    February 18, 2011
    Manufacturer
    ST JUDE MEDICAL BRASIL LTDA.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THIS VALVE WAS EXPLANTED DUE TO AORTIC ROOT ENDOCARDITIS, WHICH CAUSED AORTIC INCOMPETENCE. THE VALVE WAS REPLACED WITH AN AORTIC HOMOGRAFT AND THE PATIENT IS DOING WELL SO FAR. THE PATIENT WAS REPORTED TO HAVE HAD ENDOCARDITIS AT THE TIME OF IMPLANTATION WITH AN UNKNOWN MICROORGANISM. THE SURGEON STATED THAT IT WAS AN AGGRESSIVE ENDOCARDITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SJM EPIC VALVE TISSUE HEART VALVE LWR ST JUDE MEDICAL BRASIL LTDA. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R