BEUDAMED
    FDA Adverse Event Summary report: N

    CRANIAL NAVIGATION SOFTWARE (VERSION 2.1)

    MDR report key: 3970688 · Received July 21, 2014

    Report

    Report Number
    8043933-2014-00026
    Date Received
    July 21, 2014
    Date of Event
    June 6, 2014
    Report Date
    June 19, 2014
    Manufacturer
    BRAINLAB AG
    Product Code
    HAW
    PMA / PMN Number
    K092467
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A COMPREHENSIVE INVESTIGATION BY BRAINLAB REGARDING THE CORRESPONDING EVENTS AND USE OF THE BRAINLAB DEVICE IS CURRENTLY STILL ONGOING. ACCORDING CONCLUSION FOLLOWING THE COMPLETION OF THE BRAINLAB INVESTIGATION ARE PENDING. BRAINLAB PLANS TO ISSUE A F/U REPORT TO THE FDA UPON COMPLETION OF INVESTIGATION. A RISK TO THE PT'S HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES, SINCE THE ELECTRODES WERE PLACED IN ANOTHER POSITION AS INTENDED, WITH THE BRAINLAB DEVICE INVOLVED.

    Description of Event or Problem · 1

    TWO CRANIAL SURGERIES WERE PERFORMED WITH THE BRAINLAB CRANIAL NAVIGATION SYSTEM, IN WHICH BILATERAL ELECTRODES WERE PLACED FOR EPILEPSY RECORDING. FOR EACH SURGERY (DIFFERENT PTS) THE SURGEON PLANNED TWO TRAJECTORIES, PERFORMED REGISTRATION OF THE PT (MATCHING OF VIRTUAL DISPLAY OF PT IMAGE DATA AND ACTUAL PT ANATOMY), ACCEPTED THE RESULT AND PLACED A FLEXIBLE ELECTRODE USING THE BRAINLAB CRANIAL NAVIGATION SYSTEM, REPEATED THE SAME STEPS FOR THE SECOND ELECTRODE. IN POST-OPERATIVE IMAGING THE SURGEON DETECTED THAT THE ACTUAL ENTRY POINTS OF THE ELECTRODES DEVIATES FROM THEIR PLANNED ENTRY POINTS. THE DEVIATION WAS 15 MM FOR THE FIRST PT. NONETHELESS, IT WAS POSSIBLE TO RECORD THE DESIRED SIGNAL. FOR THE SECOND PT, THE DEVIATION COULD NOT BE MEASURED BECAUSE THE PT REMOVED THE ELECTRODES IN SPONTANEOUS EPILEPSY. THE ELECTRODES ARE PLANNED TO BE REPOSITIONED WITH AN ADD'L SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    425116 CRANIAL NAVIGATION SOFTWARE (VERSION 2.1) IMAGE GUIDED SURGERY SYSTEM/STEROT. HAW BRAINLAB AG 22214B NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other