BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTH S8 PREMIUM

    MDR report key: 8605502 · Received May 13, 2019

    Report

    Report Number
    1723170-2019-02323
    Event Type
    Malfunction
    Date Received
    May 13, 2019
    Date of Event
    May 8, 2019
    Report Date
    August 8, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TEST THE NAVIGATION SYSTEM. THE REPORTED ISSUE COULD NOT BE CONFIRMED. NO PARTS WERE REPLACED AND THE SYSTEM WAS WORKING AS INTENDED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    A SOFTWARE ANALYSIS WAS INITIATED. HOWEVER, THE SOFTWARE EVALUATION FOUND THAT A PROBABLE CAUSE WAS UNABLE TO BE DETERMINED. IT WAS SUSPECTED THAT THE REGISTRATION WAS POOR. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735736, SOFTWARE VERSION: 1.2.0. 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 DURING A FUNCTIONAL ENDOSCOPIC SINUS SURGERY (FESS) PROCEDURE. IT WAS REPORTED THAT DURING A CLINICAL CASE, THE DOCTOR STATED HE WAS INACCURATE BY ABOUT 3MM WHILE NAVIGATING. THE PATIENT HAD TAPE ON THE NOSE, SO WHEN THEY REGISTERED THEY WEREN'T ABLE TO COLLECT MANY TRACE POINTS ON THAT AREA. WITH ADDITIONAL TOUCH POINTS THEY WERE ABLE TO GET THE REGISTRATION ERROR METRIC DOWN TO 2.7MM. THE YELLOW ZONE OF ACCURACY COVERED THE ENTIRE SINUS AREA. THE EXAM WAS ABOUT A MONTH OLD AT THE TIME OF THE CASE. NO DELAY AND HE CONTINUED THE CASE BY ACCOUNTING FOR THE INACCURACY. THERE WAS NO REPORTED IMPACT TO PATIENT OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED ADDITIONAL INFORMATION THAT THE ARCHIVE WAS REVIEWED. IT WAS NOTED THAT THERE WERE FOUR REGISTRATIONS ON THE PATIENT ARCHIVE. THE REGISTRATION MODEL HAD A ROUGH SURFACE WITH POINTS COLLECTED BENEATH THE SURFACE. ALL FOUR REGISTRATIONS HAD GOOD COVERAGE OVER THE NOSE, BUT THE EVENT STATED THAT THERE WAS TAPE ON THE NOSE THAT GOT IN THE WAY OF TRACING. IT WAS SUSPECTED THAT THE TRACING OVER THE TAPE MAY HAVE SKEWED THE REGISTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398997 STEALTH S8 PREMIUM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9735665 00643169722187

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR