BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM EPIC STENTED TISSUE VALVE

    MDR report key: 1971491 · Received January 21, 2011

    Report

    Report Number
    3001743903-2011-00001
    Event Type
    Injury
    Date Received
    January 21, 2011
    Date of Event
    December 14, 2010
    Report Date
    January 21, 2011
    Manufacturer
    ST. JUDE MEDICAL BRASIL LTDA.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE VALVE WAS EXPLANTED DUE TO CALCIFICATION AND STENOSIS AND REPLACED WITH A LARGER 23 MM SJM EPIC VALVE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SJM EPIC STENTED TISSUE VALVE STENTED TISSUE VALVE LWR ST. JUDE MEDICAL BRASIL LTDA. EL-21A

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R