BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ST. JUDE SILZONE VALVE

    MDR report key: 661990 · Received November 16, 2005

    Report

    Report Number
    MW1037544
    Event Type
    Injury
    Date Received
    November 16, 2005
    Date of Event
    January 18, 2000
    Report Date
    November 7, 2005
    Manufacturer
    ST. JUDE MEDICAL, INC
    Product Code
    LWR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    ST. JUDE SILZONE VALVE IMPLANTED TWO DAYS PRIOR TO VOLUNTARY RECALL. DEVELOPED MODERATE MITRAL REGURGITATION AS NOTED DURING 2003 CATHETERIZATION. UNDERWENT 2ND OPEN HEART SURGERY AT WHICH TIME A PERIVASCULAR LEAK WAS DOCUMENTED BY SURGEON. PRIOR TO 2ND SURGERY EXPERIENCED TIAS. NO RECURRENCE OF TIAS NOTED FOLLOWING 2ND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST. JUDE SILZONE VALVE MITRAL VALVE (HEART DEVICE) LWR ST. JUDE MEDICAL, INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| L| R