BEUDAMED
    FDA Adverse Event Death Summary report: N

    CL-NOVALIS TX

    MDR report key: 1715036 · Received June 8, 2010

    Report

    Report Number
    2916710-2010-00061
    Event Type
    Death
    Date Received
    June 8, 2010
    Date of Event
    May 10, 2010
    Report Date
    May 10, 2010
    Manufacturer
    VARIAN MEDICAL SYSTEMS
    Product Code
    IYE
    PMA / PMN Number
    K070094
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B) (6) 2010, THE PATIENT'S MOTHER INFORMED VARIAN THAT HER DAUGHTER HAD PASSED AWAY, AND DECLINED TO PROVIDE ANY FURTHER INFORMATION, INCLUDING THE DATES OF TREATMENT, ON ADVICE FROM HER LAWYERS. NO OTHER DETAILS OF THE EVENT HAVE BEEN REPORTED TO VARIAN. ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    PATIENT'S MOTHER CALLED WITH AN ALLEGATION THAT HER DAUGHTER HAD BEEN MISTREATED WITH A NOVALIS TX. ON (B) (6) 2010, VARIAN RECEIVED A CALL FROM A PATIENT'S MOTHER WITH AN ALLEGATION THAT HER DAUGHTER HAD BEEN MISTREATED WITH A NOVALIS TX. THE PATIENT HAD RADIOSURGERY ON A NOVALIS TX AT (B) (6) IN (B) (6). THE DOCTORS INFORMED THE PATIENT'S MOTHER THAT THE RADIATION, "WENT INTO AN AREA THAT IT WASN'T SUPPOSED TO GO TO, BEYOND THE AREA THAT THEY TARGETED." IN ADDITION, THE PATIENT'S MOTHER WAS CALLING FOR INFORMATION ABOUT RECALLS ON THE NOVALIS TX MACHINE DURING 2009 AND 2010. SHE SAID THE STAFF AT (B) (6) TOLD HER THAT THE MACHINE WAS SUBJECT TO A RECALL, AND WHEN SHE ASKED THE FACILITY STAFF FOR DETAILS, THEY REFERRED HER TO THE MANUFACTURER. (B) (6)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CL-NOVALIS TX LINEAR ACCELERATOR IYE VARIAN MEDICAL SYSTEMS

    Patients

    Seq Age Sex Outcome Treatment
    1 Death