BEUDAMED
    FDA Adverse Event Other Summary report: N

    LEKSELL GAMMA PLAN V5.34

    MDR report key: 797423 · Received December 7, 2006

    Report

    Report Number
    9612186-2006-00006
    Event Type
    Other
    Date Received
    December 7, 2006
    Date of Event
    November 7, 2006
    Report Date
    December 6, 2006
    Manufacturer
    ELEKTA INSTRUMENT AB
    Product Code
    MUJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE IMAGE STUDIES SENT OT ELEKTA CONTAINED CORONAL AND AXIAL IMAGES OBTAINED WITH TWO DIFFERENT SETTINGS. AXIAL AND CORONAL IMAGES WITH THE SAME CONTRAST SETTINGS WERE FUSED. WHEN SHIFTING THE CONTRIBUTION FROM AXIAL AND CORONAL STUDY USING THE MIXING FUNCTIONALITY THE ANATOMICAL STRUCTURES GRADUALLY MOVED. THIS IS AN INDICATION OF THE DISCREPANCY BETWEEN THE AXIAL AND CORONAL STUDIES. MR IMAGES ARE SUUSCEPTIBLE TO SPATIAL DISTORTIONS CAUSED BY SEVERAL FACTORS, WHICH INCLUDE INHOMOGENEITIES OF THE CONSTANT MAGNETIC FIELD, NONLINEARITY OF THE GRADIENT FIELD, LINEAR SCALE ERROR, INSTRUMENT IMPERFECTIONS, MAGNETIC SUSCEPTIBILITY ARTIFACTS, AND LOCAL MAGNETIZATION EFFECTS. THE MAXIMUM DISTORTION APPEARS MOST COMMONLY IN THE CORONAL DIRECTION. THE "INSTRUCTIONS FOR USE" FOR GAMMAPLAN INCLUDES INFORMATION THAT CORRECTION OF DISTORTED IMAGES ARE NOT DONE BY THE SOFTWARE AND CONTAINS A WARNING STATING THAT THE USER SHOULD HAVE A STANDARD PROCEDURE FOR STEREOTACTIC LOCALIZATION AND MEASURE THE GEOMETRICAL DISTORTIONS WITH A WATER PHANTOM TO ASCERTAIN THAT SUCH DISTORTIONS REMAIN WITHIN ACCEPTABLE TOLERANCE LIMITS. THE IMPORTANCE TO ONLY USE NON-MAGNETIC MATERIALS WITH MR IMAGING IS ALSO STATED.

    Description of Event or Problem · 1

    A DISCREPANCY BETWEEN AXIAL AND CORONAL VIEWS OF THE TUMOR TARGETS HAVE BEEN NOTICED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEKSELL GAMMA PLAN V5.34 RADIATION THERAPY MUJ ELEKTA INSTRUMENT AB * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *