BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION® I7¿ INTEGRATED NAVIGATION SYSTEM

    MDR report key: 3091953 · Received May 3, 2013

    Report

    Report Number
    1723170-2013-00310
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    June 10, 2013
    Report Date
    June 10, 2013
    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

    THE EXAM FROM THE REPORTED INCIDENT WAS REVIEWED BY MEDTRONIC ENGINEERING. THE POINTMERGE REGISTRATION SHOWED THE SPHERE OF ACCURACY COULD HAVE BEEN IMPROVED BY STORING AND MATCHING ADDITIONAL POINTS ON THE POSTERIOR SIDE OF THE HEAD WHERE THE AREA OF INTEREST WAS. THE REGISTRATION DISPLAYED NO POINTS NEAR THE AREA OF INTEREST AND OUT OF THE 4 POINTS USED IN THE REGISTRATION, 2 POINTS WERE RIGHT NEXT TO EACH OTHER BEHIND THE EAR. WITH THE INFORMATION PROVIDED, IT IS UNKNOWN IF THE PATIENT'S MOVEMENT DURING SURGERY COULD HAVE RESULTED IN INACCURACY. UPON COMPLETION OF THE SOFTWARE INVESTIGATION, NO SOFTWARE FAULTS OR ANOMALIES WERE FOUND TO BE THE CAUSE OF THE ALLEGED INACCURACY.

    Additional Manufacturer Narrative · 1

    THE SOFTWARE INVESTIGATION HAS NOT BEEN COMPLETED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A CRANIAL TUMOR RESECTION THAT THE SURGEON WAS APPROXIMATELY 1CM OFF DURING NAVIGATION. HE WAS ACCURATE AFTER REGISTRATION AND CONFIRMED THIS BY TOUCHING LANDMARKS. THEY WENT STERILE AND HE WAS INITIALLY ACCURATE WHILE NAVIGATING. APPROXIMATELY 2 HOURS INTO THE CASE, THE CRANIOTOMY WAS COMPLETED AND TUMOR RESECTION WAS IN PROGRESS WHEN SURGEON CLAIMED A 1CM INACCURACY. THE PATIENT WAS IN THE PRONE POSITION AND WAS REPORTED BY ANESTHESIA REP TO HAVE SIGNIFICANTLY "BUCKED" FROM THE ANESTHESIA AFTER GOING STERILE. THE SURGEON CLAIMS THE HEAD FRAME PINS AND THE FRAME DID NOT MOVE WHEN THE PATIENT "BUCKED". PATIENT WAS GETTING AN INTEROP MRI TO CONFIRM RESECTION. THE SURGEON DID NOT WANT TO STEALTH MERGE THE NEW MRI WITH THE OLD ONE TO CHECK ACCURACY. HE ALSO DID NOT WANT TO TRY TO RE-REGISTER. TUMOR RESECTION WAS COMPLETED WITH THE USE OF THE MICROSCOPE AND NAVIGATION WAS DISCONTINUED. NO NEGATIVE IMPACT TO THE PATIENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194336 STEALTHSTATION® I7¿ INTEGRATED NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. I7

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR