BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3833205 · Received May 27, 2014

    Report

    Report Number
    1723170-2014-00609
    Event Type
    Malfunction
    Date Received
    May 27, 2014
    Date of Event
    May 14, 2014
    Report Date
    May 14, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    TWO MEDTRONIC REPRESENTATIVES, FOLLOWING-UP AT THE SITE, REPORTED THEY WERE ABLE TO CONFIRM THAT THE SITE PERFORMED A NUMBER OF UNAUTHORIZED ACTIVITIES ON THE STEALTHSTATION S7 SYSTEM; IN DOING SO, THE TAMPER SEAL ON THE COMPUTER WAS DAMAGED AND THE UPS BATTERIES AND POWER CORDS WERE REPLACED USING NON-MEDTRONIC PARTS. A SYSTEM CHECK-OUT TO VERIFY ACCURACY HAS NOT BEEN DONE BY MEDTRONIC PERSONNEL AND THE SITE DOES NOT WANT TO PURSUE IT ANY FURTHER AT THIS TIME. IT WAS STATED THAT THE SITE IS AWARE THAT THEY ARE NOT ABLE TO PROPERLY SERVICE THE SYSTEMS THEMSELVES. UNABLE TO SERVICE OR PERFORM SYSTEM CHECK-OUT UNTIL THE SYSTEM TO BE BROUGHT UP INTO SPEC WITH MEDTRONIC APPROVED PRODUCTS. THE REPORTED ISSUE HAS BEEN DETERMINED TO BE A USE ERROR, THE DEVICE WAS INCORRECTLY MODIFIED. THIS IS NOT A FAILURE OF A MEDTRONIC PRODUCT. MEDTRONIC NAVIGATION IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S STEALTHSTATION S7 SYSTEM. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THREE COMPONENTS OF THE NAVIGATION SYSTEM WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE BATTERY THAT WAS RETURNED WAS NOT A MEDTRONIC PART. THE CABLE WAS REMOVED FROM THE OLD BATTERY AND RECONNECTED. THE BATTERY WAS THE CORRECT VOLTAGE. NO FURTHER TESTING WAS PERFORMED AS THIS WAS A NON-MEDTRONIC PART. THE RETURNED POWER CABLE PASSED A FUNCTIONAL AND ELECTRICAL TEST. HOWEVER, THE POWER AND GROUND PINS ON THE PLUG HAVE BEEN BENT. THE PLUG APPEARS TO HAVE BEEN REMOVED FROM THE WALL OUTLET INCORRECTLY BENDING THE PINS. THE RETURNED COMPUTER INITIAL POWER ON WAS SUCCESSFUL. THE SYSTEM BOOTED TO LOGIN SCREEN AND VIDEO OUTPUT APPEARED NORMAL. NO FAULTS WERE ENCOUNTERED. VISUAL INSPECTION OF VIDEO GRAPHICS CARD DID NOT REVEAL ANY DAMAGE OR MODIFICATIONS. THE COMPUTER WAS RETIRED FROM SERVICE AS THE TAMPER SEALS WERE BROKEN BY THE CUSTOMER. THE SOFTWARE INVESTIGATION FOUND THAT THE SITE HAD REPAIRED/REPLACED SYSTEM COMPONENTS INCLUDING SYSTEM COMPONENTS, SUCH AS THE BATTERY, AND BREAKING THE TAMPER SEALS ON THE COMPUTER. BY DOING SO, THE SYSTEM WAS NO LONGER VALID FOR NAVIGATION AND THE SITE WAS ADVISED OF THIS. THE SITE AGREED TO HAVE THEIR NAVIGATION EQUIPMENT SERVICED BY MEDTRONIC PERSONNEL. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT AND REPLACE THE COMPONENTS. AFTER SERVICING THE SYSTEM, THE HARDWARE AND SOFTWARE PASSED THE SYSTEM CHECKOUT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A CRANIAL BIOPSY PROCEDURE, THE SURGEON ALLEGED A 1CM INACCURACY. TOUCH-N-GO REGISTRATION WAS UNSUCCESSFUL, THE SURGEON USED TRACER TO REGISTER THE PATIENT. THE SURGEON STATED THAT THE ANATOMICAL LANDMARKS WERE ACCURATE, HOWEVER, DEEMED BEING INACCURATE WHEN TOUCHING THE FIDUCIALS. THE SURGEON REPORTED TOUCHING THE DURA WHILE NAVIGATING, AND THE SOFTWARE SHOWING 1CM DEEPER IN THE ANATOMY. THE SURGEON OPTED TO DISCONTINUE THE USE OF THAT SYSTEM AND BROUGHT IN A SECOND NAVIGATION SYSTEM TO CONTINUE THE PROCEDURE. THE PATIENT WAS RE-REGISTERED AND ACCURACY WAS CHECKED, THE SURGEON DEEMED THEY WERE ACCURATE AND PROCEEDED. IT WAS INDIRECTLY REPORTED TO A MEDTRONIC REPRESENTATIVE THAT THE SITE'S BIOMED DEPARTMENT REPLACED THE VIDEO CARD IN THE SYSTEM COMPUTER AND SINCE THAT TIME, THE NAVIGATION SYSTEM HAS NOT BEEN ACCURATE. NO FURTHER DETAILS REGARDING THE ALLEGATION OF INACCURACY, OR HOW OR WHY THE VIDEO CARD REPLACEMENT OCCURRED, WERE PROVIDED. MEDTRONIC NAVIGATION, INC. IS FILING THIS MDR TO ENSURE VISIBILITY TO A PATIENT EVENT AS A RESULT OF A PROCEDURE THAT UTILIZED MEDTRONIC NAVIGATION'S STEALTHSTATION S7 SYSTEM. THERE IS NO ALLEGATION TO SUGGEST THAT MEDTRONIC NAVIGATION'S DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311636 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR