BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIFECTA VALVE

    MDR report key: 2160805 · Received July 7, 2011

    Report

    Report Number
    3001743903-2011-00041
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    January 25, 2011
    Report Date
    July 7, 2011
    Manufacturer
    ST. JUDE MEDICAL BRASIL LTDA.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED, AFTER THE VALVE WAS IMPLANTED AND DURING DISCHARGE ECHO, PERICARDIAL EFFUSION WAS NOTICED. A DRAIN WAS PLACED DUE TO A RIGHT ATRIAL HEMATOMA. THE EVENT WAS RESOLVED AND THE PATIENT WAS DISCHARGED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIFECTA VALVE NONE LWR ST. JUDE MEDICAL BRASIL LTDA. TF-23A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R