BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTH S8 PREMIUM

    MDR report key: 9146089 · Received October 2, 2019

    Report

    Report Number
    1723170-2019-05087
    Event Type
    Malfunction
    Date Received
    October 2, 2019
    Date of Event
    September 11, 2019
    Report Date
    November 20, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE NAVIGATION SYSTEM FUNCTIONED AS DESIGNED. THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735762, SOFTWARE VERSION: 1.2.0. THE SOFTWARE INVESTIGATION WAS UNABLE TO DETERMINE PROBABLE CAUSE WITHOUT FURTHER INFORMATION SINCE THE ON-GOING INVESTIGATION PROVED TO BE INCONCLUSIVE BASED ON THE INFORMATION PROVIDED. LOGS AND ARCHIVE WERE REVIEWED BUT PROVIDED INSUFFICIENT INFORMATION TO DETERMINE THE ROOT CAUSE OF THE REPORTED BEHAVIOR. THE SCANNING PROTOCOL OF EXAM HAD DIFFERENT SLICE SPACING AND THICKNESS. SEVERAL REGISTRATIONS WERE OBSERVED IN ARCHIVES AND LOGS WITH METRICS RANGING FROM 2.6 MM TO 9.9 MM. IN MANY REGISTRATIONS, POINTS WERE CAPTURED UNDER THE SKIN. ALSO IT SEEMED THE ORIENTATION DID NOT HAPPEN CORRECTLY IN A FEW OF THE REGISTRATIONS. USER COULD HAVE TRACED MORE POINTS COVERING NOSE, FOREHEAD AND BACKSIDE OF HEAD TO IMPROVE THE REGISTRATION METRIC. AUTO-REFINE OF THE MODEL WOULD HAVE HELPED THE POINT UNDER THE SKIN. (B)(4). 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 SYSTEM BEING USED INTRA-OPERATIVELY OF A CRANIAL RESECTION PROCEDURE. IT WAS REPORTED THAT DURING A CLINICAL CASE TODAY, THE SURGEON EXPERIENCED A LOT OF DIFFICULTY REGISTERING THE PATIENT ON TWO STEALTH SYSTEMS ON SITE. WHEN THEY REGISTERED, IT TOOK A LONG TIME TO CALCULATE THE REGISTRATION ERROR METRIC. WHEN THEY FINALLY GOT THE ERROR METRIC UNDER 2.5MM, THE SURGEON FELT THE NAVIGATION ACCURACY WAS VERY OFF. THE SURGEON SWAPPED TO ANOTHER SYSTEM FOR THE CASE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS "ONLY TRACER. IT WAS OFF ANATOMICALLY. POINTER ON THE NOSE AND SHOWING BACK OF HEAD. AT ONE POINT, THEY COULD FOLLOW THE POINTER WHILE TRACING OVER THE HEAD, BUT IT WAS STILL INCORRECT WITH ORIENTATION. IT WAS INDICATED THAT THERE WAS NOT AN ACCURACY ISSUE, BUT ORIENTATION ISSUE¿. THERE WAS A DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940225 STEALTH S8 PREMIUM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9735665 00643169722187

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR