BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM EPIC SUPRA STENTED PORCINE HEART VALVE

    MDR report key: 3242905 · Received July 19, 2013

    Report

    Report Number
    3009024882-2013-00021
    Event Type
    Injury
    Date Received
    July 19, 2013
    Date of Event
    June 26, 2013
    Report Date
    July 2, 2013
    Manufacturer
    ST. JUDE MEDICAL COSTA RICA LTDA.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED TO SJM INDICATED A 23 MM SJM EPIC SUPRA VALVE WAS EXPLANTED. THE REASON FOR THE EXPLANT IS UNKNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338878 SJM EPIC SUPRA STENTED PORCINE HEART VALVE STENTED TISSUE VALVE LWR ST. JUDE MEDICAL COSTA RICA LTDA. ESP100-23 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R