BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIFECTA VALVE

    MDR report key: 2160784 · Received July 7, 2011

    Report

    Report Number
    3007113487-2011-00008
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    March 9, 2011
    Report Date
    July 7, 2011
    Manufacturer
    ST. JUDE MEDICAL, INC. (CS-WOODRIDGE)
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED DURING HOSPITALIZATION, THE PATIENT DEVELOPED FIRST DEGREE AV BLOCK AND SINUS TACHYCARDIA, WHICH WAS TREATED WITH A BETA BLOCKER. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRIFECTA VALVE NONE LWR ST. JUDE MEDICAL, INC. (CS-WOODRIDGE) TF-27A

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R