BEUDAMED
    FDA Adverse Event Other Summary report: N

    SIR-SPHERES

    MDR report key: 468824 · Received June 27, 2003

    Report

    Report Number
    9710358-2003-00003
    Event Type
    Other
    Date Received
    June 27, 2003
    Date of Event
    June 20, 2003
    Report Date
    June 27, 2003
    Manufacturer
    SIRTEX MEDICAL LIMITED
    Product Code
    KXK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT HAS LIVER METASTASES FROM COLORECTAL CARCINOMA, AND IS PART OF A CLINICAL TRIAL TO EVALUATE THE SAFETY OF USING A TRIPLE CHEMOTHERAPY REGIME WHICH INCLUDES THE DRUG OXALIPLATIN IN COMBINATION WITH SIR-SPHERES RADIOACTIVE BRACHYTHERAPY DEVICE. PT EXPERIENCED PAIN WITH A VASOVAGAL EPISODE WITH BRADYCARDIA DURING THE ADMINISTRATION OF THE SPHERES, WITH SUBSEQUENT POST-INSERTION PAIN, NAUSEA AND VOMITING. PAIN AND VASOVAGAL EPISODE PROHIBITED ADMINISTRATION OF FULL DOSE, A TOTAL OF 0.9 GBQ ADMINISTERED RATHER THAN THE INTENDED 1.8 GBQ.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIR-SPHERES RADIOACTIVE BRACHYTHERAPY DEVICE KXK SIRTEX MEDICAL LIMITED SIR-Y001 35770

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other