BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM EPIC STENTED TISSUE VALVE

    MDR report key: 3012559 · Received March 15, 2013

    Report

    Report Number
    3001743903-2013-00011
    Event Type
    Injury
    Date Received
    March 15, 2013
    Date of Event
    December 19, 2012
    Report Date
    March 5, 2013
    Manufacturer
    ST JUDE MEDICAL BRASIL LTDA.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED TO SJM INDICATED AN ECHO REVEALED AN ELEVATED GRADIENT AND A CALCIFIED LEAFLET. THE VALVE WAS EXPLANTED AND REPLACED WITH AN UNKNOWN DEVICE. THE PATIENT HAS BEEN DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111102 SJM EPIC STENTED TISSUE VALVE STENTED TISSUE VALVE LWR ST JUDE MEDICAL BRASIL LTDA. EL-25A

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R