BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRANIAL NAVIGATION SOFTWARE (VERSION 2.1.1)

    MDR report key: 6405600 · Received March 15, 2017

    Report

    Report Number
    8043933-2017-00009
    Event Type
    Malfunction
    Date Received
    March 15, 2017
    Date of Event
    February 16, 2017
    Report Date
    February 16, 2017
    Manufacturer
    BRAINLAB AG
    Product Code
    HAW
    UDI-DI
    04056481000493
    PMA / PMN Number
    K092467
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A RISK TO THE PATIENT'S HEALTH COULD NOT BE EXCLUDED FOR THESE SPECIFIC CIRCUMSTANCES, SINCE ELECTRODES WERE PLACED IN LOCATIONS IN THE PATIENT'S BRAIN DIFFERENT THAN PLANNED WITH THE BRAINLAB NAVIGATION DEVICE INVOLVED, DESPITE ACCORDING TO THE SURGEON: THERE WERE NO KNOWN NEGATIVE CLINICAL EFFECTS FOR THE PATIENT AT THE TIME OF SURGERY DUE TO ANESTHESIA DELAY (15 MIN) OR DUE THE ISSUE WITH INACCURATELY PLACED ELECTRODES. NO MEDICAL/SURGICAL INTERVENTION OR REMEDIAL ACTIONS WERE NECESSARY, DONE OR PLANNED FOR THIS PATIENT DUE TO THE ISSUE. THE RESULT OF THE SURGERY (OUTCOME OF ELECTRODE PLACEMENT) WAS STILL ACCEPTABLE. ACCORDING TO THE RESULTS OF THE BRAINLAB INVESTIGATION AND THE INFORMATION PROVIDED BY THE HOSPITAL, IT CAN BE CONCLUDED THAT THE ROOT CAUSES FOR THE DEVIATIONS OF THE ACTUAL POSITIONS OF THE ELECTRODES FROM THE PLANNED POSITIONS ARE: SUBOPTIMAL PATIENT REGISTRATION FOR NAVIGATION (POINTS WERE NOT COLLECTED IN ALL NECESSARY REGIONS AND NO POINTS WERE COLLECTED IN THE REGION OF INTEREST), THAT WAS APPARENTLY NOT DETECTED BY THE USER WITH THE NECESSARY VERIFICATION OF NAVIGATION ACCURACY. THE PRE-OP CT SCAN USED FOR THE PATIENT REGISTRATION FOR NAVIGATION DID NOT FULFILL THE REQUIREMENTS OF THE BRAINLAB SCAN PROTOCOL, AS IT WAS SHOWING ARTEFACTS AND THE PATIENT HAD PLASTER ON THE SKIN DURING THE SCAN CAUSING SKIN SHIFT. FURTHER POSSIBLY CONTRIBUTING FACTOR IS: THE MARKER SPHERES USED FOR UNSTERILE INSTRUMENT (POINTER) WERE NOT NEW/UNUSED AS REQUIRED. THERE IS NO INDICATION OF A SYSTEMATIC ERROR OR MALFUNCTION OF THE BRAINLAB DEVICE (NAVIGATION) CONTRIBUTING TO THIS ISSUE AT THIS SURGERY. CORRESPONDING BRAINLAB MEASURES TO MINIMIZE THIS ANTICIPATED RISK AS LOW AS REASONABLY PRACTICABLE ARE ALREADY IN PLACE. BRAINLAB INTENDS TO RE-ITERATE THE RELEVANT TOPICS REGARDING THE USE OF THE DEVICE TO THIS CUSTOMER.

    Description of Event or Problem · 1

    A CRANIAL SURGERY FOR IMPLANTATION OF 12 SEEG ELECTRODES INTO THE PATIENT'S BRAIN (TO TREAT EPILEPSY) WAS PERFORMED WITH THE AID OF THE VIRTUAL DISPLAY OF THE BRAINLAB NAVIGATION SW VERSION 2.1.1. A PRE-OPERATIVE CT SCAN WAS ACQUIRED THE DAY BEFORE SURGERY, TO USE WITH NAVIGATION. TRAJECTORIES FOR THE 12 ELECTRODES WERE PLANNED ON PRE-OPERATIVE CT SCANS AND MRI SCANS BEFORE THE SURGERY WITH BRAINLAB PLANNING SW IPLAN 3.0.5. DURING THE PROCEDURE THE SURGEON: POSITIONED THE PATIENT IN THE SUPINE ORIENTATION IN A HEAD HOLDER. PERFORMED THE INITIAL PATIENT REGISTRATION ON THE PRE-OP CT SCAN WITH SURFACE MATCHING TO MATCH THE VIRTUAL DISPLAY OF THE NAVIGATION TO THE CURRENT PATIENT ANATOMY. SEVERAL ATTEMPTS WERE NECESSARY TO ACHIEVE A DESIRED REGISTRATION ACCURACY. DRAPED THE PATIENT, VERIFIED THE ACCURACY OF THE REGISTRATION AND DETERMINED THE RESULT AS GOOD. CREATED THE BURR HOLES, AND PLACED 12 SEEG ELECTRODES WITH AID OF NAVIGATION. A POST-OPERATIVE SCAN WAS PERFORMED, AND THE SURGEON DETERMINED THAT THE FIRST 5 ELECTRODES WERE IMPLANTED WITHIN DESIRED ACCURACY STANDARDS (BELOW 3 MM), HOWEVER, THE ELECTRODE LOCATIONS OF THE LAST 7 ELECTRODES DIFFERED BY CA. 3MM TO CA. 4.5MM FROM THE PLANNED TRAJECTORY AT ENTRY POINT. ACCORDING TO THE SURGEON: THE RESULTS OF THE SURGERY/ELECTRODE PLACEMENT WERE STILL ACCEPTABLE. THERE WERE NO KNOWN NEGATIVE EFFECTS TO THE PATIENT AT THE TIME OF SURGERY, NEITHER DUE TO ELECTRODE PLACEMENTS NOR DUE TO PROLONGATION OF SURGERY/ANESTHESIA (OF CA. 15 MIN). NO MEDICAL/SURGICAL INTERVENTION NOR REMEDIAL ACTIONS WERE NECESSARY, DONE OR PLANNED FOR THIS PATIENT DUE TO THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190457 CRANIAL NAVIGATION SOFTWARE (VERSION 2.1.1) IMAGE GUIDED SURGERY SYSTEM/INSTRUMENT, STEREOTAXIC HAW BRAINLAB AG 22214A SW V. 2.1.1 04056481000493

    Patients

    Seq Age Sex Outcome Treatment
    1 Other