BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM EPIC SUPRA STENTED VALVE W/ FLEXFIT SYSTEM

    MDR report key: 2780531 · Received October 5, 2012

    Report

    Report Number
    3001743903-2012-00067
    Event Type
    Injury
    Date Received
    October 5, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 25, 2012
    Manufacturer
    ST JUDE MEDICAL BRASIL LTDA.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ECHOCARDIOGRAPHY REVEALED AN ELEVATED GRADIENT AND THE VALVE WAS EXPLANTED. THE PT WAS REPORTED TO BE FINE POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SJM EPIC SUPRA STENTED VALVE W/ FLEXFIT SYSTEM STENTED TISSUE VALVE LWR ST JUDE MEDICAL BRASIL LTDA. ESP100-21

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R