BEUDAMED
    FDA Adverse Event Death Summary report: N

    ECLIPSE

    MDR report key: 2142454 · Received June 17, 2011

    Report

    Report Number
    3003793371-2011-00021
    Event Type
    Death
    Date Received
    June 17, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 15, 2011
    Manufacturer
    VARIAN MEDICAL SYSTEMS, FINLAND OY
    Product Code
    MUJ
    PMA / PMN Number
    K091492
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL FOLLOW-UP TO THIS MDR IS EXPECTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER CALLED TO REPORT THAT A PATIENT TREATED IN THE HEAD AND NECK REGION IN (B)(6) 2008, HAD EXPIRED DUE TO RADIATION COMPLICATION CALLED "RADIATION NECROSIS OF THE CERVICAL SPINE". THIS IS BELIEVED BY THE CUSTOMER, TO RESULT FROM INCORRECT ISOCENTER POSITIONING BETWEEN THE LINAC AND TREATMENT PLANNING SYSTEMS (ECLIPSE AND BRAINSCAN).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ECLIPSE SYSTEM, PLANNING, RADIATION THERAPY TREAT MUJ VARIAN MEDICAL SYSTEMS, FINLAND OY H48

    Patients

    Seq Age Sex Outcome Treatment
    1 Death