BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARISEED

    MDR report key: 1599859 · Received February 4, 2010

    Report

    Report Number
    1124791-2010-00001
    Event Type
    Injury
    Date Received
    February 4, 2010
    Date of Event
    January 1, 2004
    Report Date
    February 5, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    MUJ
    PMA / PMN Number
    K982821
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE ADVERSE EVENT WAS CAUSED BY USER ERRORS AND DEVICE EVALUATION IS NOT APPLICABLE. THE NEW YORK TIMES ARTICLE. THE RADIATION BOOM. AS TECHNOLOGY SURGES, RADIATION SAFEGUARDS LAG BY WALT BOGDANICH. (B) (4).

    Description of Event or Problem · 1

    PATIENT UNDER TREATMENT FOR PROSTATE CANCER RECEIVED A RADIATION OVERDOSE. THE FIRST HALF OF THE TREATMENT WAS DELIVERED EXTERNAL BEAM THERAPY WITH A CLINAC DEVICE AND SECOND HALF OF THE TREATMENT WAS A RADIOACTIVE SEEDS IMPLANT PLANNED WITH VARISEED DEVICE. THE SEED IMPLANT WAS PRESCRIBED INCORRECTLY FOR A DEFINITIVE DOSE, INSTEAD OF A BOOST DOSE. THE MISTAKE IN THE PRESCRIPTION DOSAGE WAS NOT CAUGHT BY THE PHYSICIST AND THE MANUAL SEEDS WERE IMPLANTED TOO CLOSE TO THE RECTUM. USER SITE HAS STATED THAT VARISEED DID NOT MALFUNCTION, OR FACILITATE THE INCIDENT. PATIENT HAS SUSTAINED INJURIES RELATED TO RADIATION OVERDOSE INCLUDING DEVELOPING A FISTULA, RELATED INFECTIONS, AND LOSING ABILITY TO URINATE AND MOVE HIS BOWELS REQUIRING TWO EXTERNAL BAGS TO COLLECT WASTE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARISEED BRACHYTHERAPY TREATMENT PLANNING SOFTWARE MUJ VARIAN MEDICAL SYSTEMS, INC. 6.7

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability CLINAC- EXTERNAL BEAM THERAPY