BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LEKSELL STEREOTACTIC SYSTEM

    MDR report key: 1212610 · Received October 24, 2008

    Report

    Report Number
    9612186-2008-00014
    Event Type
    Injury
    Date Received
    October 24, 2008
    Date of Event
    September 30, 2008
    Report Date
    October 23, 2008
    Manufacturer
    ELEKTA INSTRUMENT AB
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIST

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS ONGOING. REMEDIAL INTERVENTION AND PATIENT CONDITION CANNOT BE DETERMINED WITH THE INFO PROVIDED BY THE USER FACILITY. MORE INFO WILL BE PROVIDED UPON CONCLUSION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    THREE BURN CASES HAVE BEEN DETECTED AFTER MRI SCANS WERE TAKEN WHILE USING THE STEREOTACTIC SYSTEM, MODEL G. TARGET CALCULATIONS WERE BASED ON 3D-T1 WEIGHTED MRI. THE T2 WEIGHTED DATASET HAS ALSO BEEN USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LEKSELL STEREOTACTIC SYSTEM INSTRUMENT, STEREOTAXIC AND ACCESSORIES HAW ELEKTA INSTRUMENT AB G

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention