BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION® S7

    MDR report key: 8429261 · Received March 18, 2019

    Report

    Report Number
    1723170-2019-01169
    Event Type
    Malfunction
    Date Received
    March 18, 2019
    Date of Event
    February 18, 2019
    Report Date
    June 3, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994450968
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COMPONENTS ARE: SOFTWARE (B)(4) STEALTHSTATION CRANIAL; 510K K153660; UDI: (B)(4). 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. THE SYSTEM LOGS WERE REVIEWED BUT PROVIDED NO ADDITIONAL INFORMATION ON THE CAUSE OF THE ISSUE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS REFUSE BY THE SITE.) A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE SYSTEM FUNCTIONED AS INTENDED AFTER UPGRADING THE SOFTWARE TO THE NEWEST VERSION. 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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE AXIEM NAVIGATION WAS SUDDENLY NOT FUNCTIONAL INTRA/PERI-OPERATIVELY DURING THE REGISTER TASK OF A CRANIAL PROCEDURE. THE SITE STATED THAT THE TRACER POINTER WERE NOT TRACKABLE DURING EM. THE EXCHANGE OF THE WHOLE NAVIGATION SYSTEM TO A DIFFERENT SYSTEM SOLVED THE SITUATIONFOR THE PROCEDURE. THERE WAS A DELAY TO THE PROCEDURE OF LESS THAN ONE HOUR. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME. LATER THE CRANIAL SOFTWARE WAS UPGRADED TO THE LATEST VERSION AND THE SYSTEM BEGAN FUNCTIONING AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222852 STEALTHSTATION® S7 INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733858 00613994450968

    Patients

    Seq Age Sex Outcome Treatment
    1