BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLINAC 21EX

    MDR report key: 1640228 · Received March 23, 2010

    Report

    Report Number
    2916710-2010-00027
    Event Type
    Injury
    Date Received
    March 23, 2010
    Date of Event
    September 1, 2009
    Report Date
    February 24, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K913119
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE NEWS ARTICLE WAS FORWARDED TO VARIAN'S CONTRACTED MEDICAL ADVISOR, WHO INDICATED THERE IS A REASONABLE POSSIBILITY THAT PATIENT INJURY LIKELY OCCURRED. THE TINY AREAS IN THE BRAIN THAT ARE TREATED WITH THIS MODALITY ARE BELIEVED TO INCLUDE ACOUSTIC NEUROMAS, VASCULAR MALFORMATIONS, SMALL METASTATIC LESIONS AND POSSIBLY TINY PITUITARY TUMORS. THESE ARE ALL IN HIGHLY CRITICAL AREAS OF THE BRAIN AND A 50% OVERDOSE MAY CAUSE NECROSIS OF THE AREA. SO EVEN A TINY AREA THE SIZE OF A PEA AS DESCRIBED [IN THE ARTICLE] COULD BE VITAL AND SO IF THERE IS NECROSIS OR JUST SERIOUS DAMAGE THIS COULD BE A SERIOUS INJURY. FURTHER INVESTIGATION DETERMINED THAT A VARIAN CLINAC WHICH IS EQUIPPED WITH A BRAINLAB COLLIMATOR IS THE SUSPECT DEVICE IN USE AT THE TIME OF THE REPORTED EVENTS. VARIAN HAS DETERMINED THAT A MDR IS APPROPRIATE BASED ON THE MEDICAL OPINION CURRENTLY AVAILABLE. (B) (4).

    Description of Event or Problem · 1

    VARIAN MEDICAL SYSTEMS BECAME AWARE OF A NEWSPAPER NEWS ARTICLE RELEASE BY KSPR ((B) (6)). THE ARTICLE ALLEGES, "76 PATIENTS WHO HAD RECEIVED A VERY SPECIFIC TYPE OF TREATMENT FOR BRAIN TUMORS AND OTHER DIFFICULT-TO-TREAT CONDITIONS USING ITS BRAINLAB STEREOTACTIC RADIATION THERAPY SYSTEM, WERE ACCIDENTALLY EXPOSED TO RADIATION IN AMOUNTS THAT EXCEEDED THE INTENDED, THERAPEUTIC DOSE. THE AVERAGE VARIATION OF ALL THE TREATMENTS OF THE 76 PATIENTS EXCEEDED THE PRESCRIBED DOSE BY APPROXIMATELY 50 PERCENT." THE DATA FOR THIS REPORT WAS IN PUBLIC PRESS RELEASE, AND NOT DELIVERED TO VARIAN DIRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLINAC 21EX LINEAR ACCELERATOR IYE VARIAN MEDICAL SYSTEMS H27

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention