BEUDAMED
    FDA Adverse Event Summary report: N

    SIR-SPHERES

    MDR report key: 512077 · Received February 18, 2004

    Report

    Report Number
    9710358-2004-00002
    Date Received
    February 18, 2004
    Date of Event
    January 13, 2004
    Report Date
    January 14, 2004
    Manufacturer
    SIRTEX MEDICAL LIMITED
    Product Code
    KXK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT WAS RECOVERING FROM ROUTINE RIGHT HEPATIC ARTERY SIR-SPHERES ADMINISTRATION WHEN PT HAD WITNESSED 3-4 MINUTE GRAND-MAL SEIZURE. 24 HOURS AFTER THE EVENT THERE WAS NO ETIOLOGY IDENTIFIED. PT ALSO HAD A 30 MINUTE GRAND-MAL SEIZURE 11 HOURS AFTER THE SIR-SPHERES ADMINISTRATION. TREATMENT OF EVENTS SYMPTOMATIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIR-SPHERES RADIOACTIVE BRACHYTHERAPY DEVICE KXK SIRTEX MEDICAL LIMITED SIR-Y001 36791

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization