BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARISEED

    MDR report key: 1644470 · Received March 25, 2010

    Report

    Report Number
    1124791-2010-00002
    Event Type
    Injury
    Date Received
    March 25, 2010
    Date of Event
    January 21, 2010
    Report Date
    March 25, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS, INC.
    Product Code
    MUJ
    PMA / PMN Number
    K030534
    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 EVAL IS NOT APPLICABLE. (B) (4). VARIAN MEDICAL SYSTEMS, INC. BECAME AWARE OF THE ADVERSE EVENT THROUGH POST MARKET SURVEILLANCE ACTIVITIES WHEN THE EVENT WAS REPORTED IN THE (B) (4) ON MARCH 4, 2010. THE CUSTOMER HAD NOT PREVIOUSLY CONTACTED VARIAN MEDICAL SYSTEMS.

    Description of Event or Problem · 1

    ON (B) (6) 2010, A PT WAS TREATED BY BRACHYTHERAPY FOR PROSTATE CANCER WITH SIXTY FIVE (65) IODINE-125 (I-125) SEEDS. THE I-125 SEEDS WERE IMPLANTED USING REAL TIME DOSIMETRY UNDER ULTRASONIC GUIDANCE. THE WRITTEN DIRECTIVE CALLED FOR A THERAPEUTIC RADIATION DOSE OF 145 GRAY (GY) [14,500 RAD] TO THE PROSTATE VOLUME, PLUS 5 MILLIMETERS OF MARGIN, USING INTEROPERATIVE PLANNING. ON (B) (6) 2010, THE PT RETURNED FOR A 30 DAY POST-IMPLANT CT. THE SCAN SHOWED THAT THE IMPLANTED SEEDS WERE "IN AN APPROPRIATE PATTERN", BUT OUTSIDE THE INTENDED TARGET. THE INITIAL (B) (6) REPORT WAS MADE BY PHONE TO THE STATE DEP ON (B) (6). THE DOCTORS PERFORMING THE PROCEDURE - WHO ARE NOT NAMED - PLANNED TO DELIVERY RADIATION TO THE ENTIRE PROSTATE PLUS A FIVE-MILLIMETER MARGIN OUTSIDE THE GLAND. THERE IS NO INFO ON THE STATUS OF THE PT. THE SITE WAS USING VARISEED TREATMENT PLANNING SYSTEM. HOSPITAL CONTACT HAS STATED THAT VARISEED DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENT. THE USER SITE ORIGINALLY REPORTED THERE HAD BEEN A MALFUNCTION OF THE ULTRASOUND MACHINE, BUT HAVE SINCE RETRACTED THAT CLAIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VARISEED BRACHYTHERAPY TREATMENT PLANNING SOFTWARE MUJ VARIAN MEDICAL SYSTEMS, INC. 8.0

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Disability