BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIFECTA VALVE

    MDR report key: 2161839 · Received July 8, 2011

    Report

    Report Number
    3001743903-2011-00044
    Event Type
    Injury
    Date Received
    July 8, 2011
    Report Date
    July 8, 2011
    Manufacturer
    ST JUDE MEDICAL BRASIL LTDA
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE 19 MM TRIFECTA VALVE WAS IMPLANTED AND THE PATIENT DEVELOPED POSTOPERATIVE ATRIAL FIBRILLATION. INFORMATION RECEIVED INDICATED THE PATIENT WAS ADMINISTERED CONCOR TO TREAT THE ATRIAL FIBRILLATION. 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-19A

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R