BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MASTERS SERIES ROTATABLE VALVE

    MDR report key: 402067 · Received June 28, 2002

    Report

    Report Number
    2648612-2002-00033
    Event Type
    Injury
    Date Received
    June 28, 2002
    Date of Event
    November 24, 1998
    Report Date
    June 28, 2002
    Manufacturer
    ST. JUDE MEDICAL, INC.
    Product Code
    LWQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT WAS ROUTINELY ADMITTED FOR ELECTRICAL CARDIOVERSION OF ATRIAL FIBRILLATION. PRIOR TO ADMISSION PT EXPERIENCED BREATHING PROBLEMS, SWOLLEN FEET, RIGHT-HANDED WEAKNESS AND TEMPERATURE VARIATION. PERIPHERAL EMBOLISM WAS SUSPECTED. IN 11/1998, ECG DEMONSTRATED ATRIAL FIBRILLATION AND TEE SHOWED A "NORMALLY" FUNCTIONING VALVE WITH A "FREE-FLOATING" THROMBUS IN THE LEFT ATRIUM APPROXIMATELY 3.0 CM IN LENGTH. CT RULED OUT BLEEDING OR INFARCTION. HEPARIN WAS CONTINUED AND MARCOUMAR WAS ADDED. IN 12/1998, TEE REVEALED NO REDUCTION IN THE THROMBUS FORMATION AND TREATMENT WAS CONTINUED. ON 12/1998, TEE SHOWED A "MARKED" DECREASE IN THROMBUS SIZE. THE HEART WAS NORMALIZED WITH MEDICATION; HOWEVER, ATRIAL FIBRILLATION PERSISTED. THE PT WAS REPORTED TO BE IN "GOOD HEALTH" AT FOLLOW-UP IN 10/2001, AND THE VALVE REMAINS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MASTERS SERIES ROTATABLE VALVE ROTATABLE VALVE LWQ ST. JUDE MEDICAL, INC. 31MJ-501 *

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention