BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NORDICBRAINEX

    MDR report key: 2956377 · Received January 3, 2013

    Report

    Report Number
    3006738448-2012-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 21, 2012
    Manufacturer
    NORDICNEUROLAB AS
    Product Code
    LLZ
    PMA / PMN Number
    K092102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE BUG IS LOCATED IN THE PART OF THE SOFTWARE THAT HANDLES VISUALIZATION OF NERVE FIBER TRACTS THAT ARE EXTRACTED FROM A DIFFUSION TENSOR IMAGING MR SERIES. THE DETECTED ISSUE CAN CAUSE EXPORT AND VISUALIZATION OF FIBERS WITH WRONG POSITIONING IN RELATION THE UNDERLYING STRUCTURAL DATASET. THIS CAN OCCUR WHEN ALL THE FOLLOWING CRITERIA ARE MET: USING TWO DIFFERENT STRUCTURAL DATASETS THAT HAVE IDENTICAL RESOLUTION AND NUMBER OF SLICES; THE STRUCTURAL DATASETS ARE NOT ORIGINALLY ALIGNED BUT ARE THEN ALIGNED THROUGH CO-REGISTRATION IN NORDICBRAINEX. IT OCCURS WHEN CHANGING UNDERLAY IN THE 3D VIEWER FROM ONE TO THE OTHER OF THESE STRUCTURAL DATASETS AFTER PERFORMING THE FIBER TRACKING, AND THEN CREATING AND EXPORTING/VISUALIZING FIBER GROUPS. THE ISSUE IS CAUSED BY THE FIBERS NOT BEING REALIGNED TO THE CO-REGISTERED POSITION OF THE SECOND DATASET WHEN CHANGING THE UNDERLAY, BUT WHEN FIBERS ARE EXPORTED OR VISUALIZED IN THE MPR THE CO-REGISTRATION INFORMATION IS TAKEN INTO ACCOUNT, CAUSING WRONG POSITIONING OF THE FIBERS WHEN LATER VISUALIZED ON A STRUCTURAL DATASET. THE MISALIGNMENT OF THE FIBERS WILL THEN BE IN DIRECT PROPORTION TO THE ALIGNMENT PERFORMED BY THE NORDICBRAINEX COREGISTRATION BETWEEN THE TWO STRUCTURAL DATASETS. TO AVOID THIS ISSUE ONE SHOULD NOT CHANGE UNDERLAY IN THE 3D VIEWER WHEN WORKING WITH DTI AND/OR FIBER GROUPS, UNLESS ONE IS ABSOLUTELY SURE THE DATASETS DIFFER IN RESOLUTION AND/OR NUMBER OF SLICES. THIS BUG IS POTENTIALLY DANGEROUS IF THE MISALIGNMENT IS NOT SEEN BY THE USER. IN MOST CASES IT WILL PROBABLY BE DISCOVERED BY THE USER BECAUSE THE FIBERS DON'T MATCH THE ANATOMICAL STRUCTURES, BUT IF THE MISALIGNMENT IS NOT SO LARGE AND/OR THE FIBER GROUP IS LOCATED IN A PART OF THE BRAIN WHERE IT IS NOT SO EASY TO COMPARE WITH ANATOMICAL STRUCTURES, THE MISALIGNMENT IS MAYBE NOT DISCOVERED. THIS COULD THEREFORE, BE HARMFUL TO THE PATIENT IF THE INFORMATION IS USED IN FOR EXAMPLE NEUROSURGERY PLANNING.

    Description of Event or Problem · 1

    A BUG WAS DISCOVERED DURING TESTING INTERNALLY IN THE MANUFACTURER COMPANY. THE BUG WAS EVALUATED TO HAVE A PATIENT RISK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3566 NORDICBRAINEX PACS LLZ NORDICNEUROLAB AS

    Patients

    Seq Age Sex Outcome Treatment
    1