BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM EPIC STENTED PORCINE HEART VALVE

    MDR report key: 2802348 · Received October 19, 2012

    Report

    Report Number
    3001743903-2012-00064
    Event Type
    Injury
    Date Received
    October 19, 2012
    Date of Event
    September 18, 2012
    Report Date
    September 25, 2012
    Manufacturer
    ST. JUDE MEDICAL BRASIL LTDA.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED TO SJM INDICATED THE VALVE WAS EXPLANTED (REASON UNKNOWN) AND REPLACED WITH A 23 MM SJM MECHANICAL VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SJM EPIC STENTED PORCINE HEART VALVE STENTED TISSUE VALVE LWR ST. JUDE MEDICAL BRASIL LTDA. E100-23A

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R