BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM EPIC STENTED PORCINE HEART VALVE

    MDR report key: 1901545 · Received November 12, 2010

    Report

    Report Number
    3001743903-2010-00088
    Event Type
    Injury
    Date Received
    November 12, 2010
    Report Date
    November 12, 2010
    Manufacturer
    ST JUDE MEDICAL BRASIL LTDA.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE VALVE WAS EXPLANTED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SJM EPIC STENTED PORCINE HEART VALVE NONE LWR ST JUDE MEDICAL BRASIL LTDA.

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R