BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION S8 PREMIUM SYSTEM

    MDR report key: 8502411 · Received April 11, 2019

    Report

    Report Number
    1723170-2019-01670
    Event Type
    Injury
    Date Received
    April 11, 2019
    Date of Event
    February 25, 2019
    Report Date
    June 12, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT WAS NOT AVAILABLE FROM THE SITE. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE NAVIGATION SYSTEM PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. NO PARTS WERE REPLACED ON THE SYSTEM. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE SOFTWARE INVESTIGATION DETERMINE THAT THE BEHAVIOR DESCRIBED IS THE INTENDED BEHAVIOR OF THE SOFTWARE. THE SOFTWARE IS FUNCTIONING AS DESIGNED. THE FEATURE/ENHANCEMENT REQUEST IS BEING TRACKED THROUGH THE MEDTRONIC SOFTWARE DATABASE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR AN ELECTRODE AND PROBE PLACEMENT PROCEDURE. IT WAS REPORTED THAT THE SURGEON COULD NOT SUCCESSFULLY PRE-MERGE A RED-GREEN-BLUE (RGB) EXAM. THE CASE WAS NOT CANCELLED DUE TO THIS ISSUE. BUT BECAUSE THE PLANNING DATA COULD NOT BE INPUT TO THE NAVIGATION SYSTEM, THE NEUROSURGEON ¿EYE-BALLED¿ THE LOCALIZATION AND THE ACTIVE ELECTRODES. THESE HAD BEEN PLANNED FOR A HIGHLY FOCAL, DEPTH OF SULCUS IN GRAY MATTER BUT THEY ACTUALLY ENDED UP IN WHITE MATTER. IT WAS STATED THAT NAVIGATION WAS NOT COMPLETELY ABORTED. USE OF THE PLANNED ELECTRODE PLACEMENT TRAJECTORIES FOR RESPONSIVE NEUROSTIMULATION (RNS) IMPLANTATION WAS ABORTED THOUGH. IN OTHER WORDS, NAVIGATION WAS USED IN THE OPERATING ROOM (OR); HOWEVER, THE SITE WAS NOT ABLE TO IMPORT AND GUIDE THE PROCEDURE WITH A PREVIOUSLY CREATED MRI TRAJECTORY PLAN IN RGB DIGITAL INTERCOMMUNICATION OF MEDICINE (DICOM) FORMAT AS ANTICIPATED BECAUSE OF THE MERGING PROBLEM ENCOUNTERED. THEREFORE THE SURGEON HAD TO USE VISUAL INSPECTION OF THE PLANNED TRAJECTORIES RATHER THAN USING ACTUAL MRI PLANNED TRAJECTORIES TO GUIDE RNS ELECTRODES. BECAUSE OF THIS, THE ELECTRODES WERE PLACED SOME MILLIMETERS REMOVED FROM THE PLANNED SITES AND IN WHITE MATTER RATHER THAN GRAY MATTER, THEREFORE RENDERING THEM NONFUNCTIONAL AND INEFFECTIVE. THIS REQUIRED SURGICAL REVISION AT A LATER PROCEDURE. THE SITE STATED THAT HAD THEY BEEN ABLE TO UTILIZE THE SURGICAL PLANNING MRI IN THE NAVIGATION SYSTEM INTRAOPERATIVELY, THEN THE REPEAT/REVISION SURGERY WOULD NOT HAVE BEEN NECESSARY. THERE WAS A DELAY OF APPROXIMATELY 30 MINUTES DUE TO THIS ISSUE. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS DUE TO THIS EVENT. A HEALTHCARE PROFESSIONAL AT THE SITE STATED THAT THE PATIENT¿S CONDITION IS UNCHANGED. IT WAS REPORTED THAT THERE WERE NO COMPLICATIONS AND ALSO THAT THE REVISION SURGERY WAS SUCCESSFUL. THE PATIENT ARCHIVES WERE RECEIVED AND REVIEWED BY SOFTWARE ENGINEERING. SOFTWARE ENGINEERING STATED THAT THE REASON THIS RGB EXAM COULD NOT BE PRE-MERGED IS THAT IT IS IN A DIFFERENT REFERENCE SPACE FROM THE ANATOMY EXAM. THE SOFTWARE IS DESIGNED TO PRE-MERGE ONLY EXAMS THAT ARE IN THE SAME REFERENCE SPACE AS THE ANATOMY EXAM. AS SUCH, THE SOFTWARE APPEARED TO BE WORKING AS DESIGNED. HOWEVER, IT WAS NOTED THAT THERE IS A FEATURE REQUEST LOGGED FOR ENHANCING THE SOFTWARE'S ABILITY TO HANDLE THIS TYPE OF SITUATION.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION DEVICE BEING USED FOR AN ELECTRODE AND PROBE PLACEMENT PROCEDURE. IT WAS REPORTED THAT THE SURGEON COULD NOT SUCCESSFULLY PRE-MERGEAN RED-GREEN-BLUE (RGB) EXAM. THE CASE WAS NOT CANCELLED DUE TO THIS ISSUE. BUT BECAUSE THE PLANNING DATA COULD NOT BE INPUT TO THE NAVIGATION SYSTEM, THE NEUROSURGEON ¿EYE-BALLED¿ THE LOCALIZATION AND THE ACTIVE ELECTRODES. THESE HAD BEEN PLANNED FOR A HIGHLY FOCAL, DEPTH OF SULCUS IN GRAY MATTER BUT THEY ACTUALLY ENDED UP IN WHITE MATTER. IT WAS STATED THAT NAVIGATION WAS NOT COMPLETELY ABORTED. USE OF THE PLANNED ELECTRODE PLACEMENT TRAJECTORIES FOR RESPONSIVE NEUROSTIMULATION (RNS) IMPLANTATION WAS ABORTED THOUGH. IN OTHER WORDS, NAVIGATION WAS USED IN THE OPERATING ROOM (OR); HOWEVER, THE SITE WAS NOT ABLE TO IMPORT AND GUIDE THE PROCEDURE WITH A PREVIOUSLY CREATED MRI TRAJECTORY PLAN IN RGB DIGITAL INTERCOMMUNICATION OF MEDICINE (DICOM) FORMAT AS ANTICIPATED BECAUSE OF THE MERGING PROBLEM ENCOUNTERED. THEREFORE THE SURGEON HAD TO USE VISUAL INSPECTION OF THE PLANNED TRAJECTORIES RATHER THAN USING ACTUAL MRI PLANNED TRAJECTORIES TO GUIDE RNS ELECTRODES. BECAUSE OF THIS, THE ELECTRODES WERE PLACED SOME MILLIMETERS REMOVED FROM THE PLANNED SITES AND IN WHITE MATTER RATHER THAN GRAY MATTER, THEREFORE RENDERING THEM NONFUNCTIONAL AND INEFFECTIVE. THIS REQUIRED SURGICAL REVISION AT A LATER PROCEDURE. THE SITE STATED THAT HAD THEY BEEN ABLE TO UTILIZE THE SURGICAL PLANNING MRI IN THE NAVIGATION SYSTEM INTRAOPERATIVELY, THEN THE REPEAT/REVISION SURGERY WOULD NOT HAVE BEEN NECESSARY. THERE WAS A DELAY OF APPROXIMATELY 30 MINUTES DUE TO THIS ISSUE. THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS DUE TO THIS EVENT. A HEALTHCARE PROFESSIONAL AT THE SITE STATED THAT THE PATIENT¿S CONDITION IS UNCHANGED. IT WAS REPORTED THAT THERE WERE NO COMPLICATIONS AND ALSO THAT THE REVISION SURGERY WAS SUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295719 STEALTHSTATION S8 PREMIUM SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9735665 00643169722187

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR Required Intervention