BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM EPIC STENTED PORCINE HEART VALVE

    MDR report key: 3181317 · Received June 14, 2013

    Report

    Report Number
    3009024882-2013-00016
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 6, 2013
    Manufacturer
    ST. JUDE MEDICAL, COSTA RICA LTDA.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ECHOCARDIOGRAPHY REVEALED ELEVATED GRADIENTS. THE VALVE WAS EXPLANTED ON (B)(6) 2013 AND REPLACED WITH A 21 MM SJM TRIFECTA VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271220 SJM EPIC STENTED PORCINE HEART VALVE STENTED TISSUE VALVE LWR ST. JUDE MEDICAL, COSTA RICA LTDA. E100-23A-00 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R