BEUDAMED
    FDA Adverse Event Death Summary report: N

    MASTERS SERIES ROTATABLE VALVE W/SILZONE COATING

    MDR report key: 432429 · Received December 12, 2002

    Report

    Report Number
    2648612-2002-00056
    Event Type
    Death
    Date Received
    December 12, 2002
    Date of Event
    October 28, 1999
    Report Date
    December 12, 2002
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IN 1999, THE PT EXPERIENCED INCREASED SOB ON EXERTION, EDEMA IN BOTH ANKLES, WEIGHT LOSS, DECREASED APPETITE, AND "MINOR" PVL WITH AN INR LEVEL OF 1.0. ECHO DEMONSTRATED THEIR LV FUNCTION WAS WITHIN "NORMAL" LIMITS. THE PT'S HEMOGLOBIN WAS 7.2 AND THEY WERE ADMITTED FOR A TRANSFUSION. FOURTEEN DAYS LATER, THE PT WAS ADMITTED TO THE HOSPITAL FOR POSSIBLE PVL. ECHO SHOWED "MILD" AORTIC REGURGITATION AND EVALUATION REVEALED EVIDENCE OF HEMOLYSIS AND POSSIBLE THROMBOSIS OF THE VALVES. THE PT WAS NOT TAKING COUMADIN AT THE TIME AND LEFT THE HOSPITAL AMA. ACCORDING TO SJM PDT DATABASE, THE PT EXPIRED IN 1999. NO ADD'L INFO WAS RECEIVED, INCLDUING THE PT'S CAUSE OF DEATH. NO ADD'L INFO WAS RECEIVED, INCLUDING THE PT'S CAUSE OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MASTERS SERIES ROTATABLE VALVE W/SILZONE COATING ROTATABLE SILZONE VALVE LWQ ST. JUDE MEDICAL, INC. 29MS-601 *

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death