BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM EPIC STENTED TISSUE VALVE

    MDR report key: 1132632 · Received August 22, 2008

    Report

    Report Number
    3001743903-2008-00039
    Event Type
    Injury
    Date Received
    August 22, 2008
    Date of Event
    August 13, 2008
    Report Date
    August 22, 2008
    Manufacturer
    ST. JUDE MEDICAL BRASIL LTDA.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED 6 MONTHS POST-OP THE PT PRESENTED WITH HIGH GRADIENT AND REDUCED OPENING AREA. THE GRADIENT WAS 120MM HG AND THEREFORE IT WAS DECIDED TO EXPLANT THE VALVE. ADD'L INFO 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-23A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R