BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S8 STEALTHSTATION NAVIGATION SYSTEM

    MDR report key: 8064026 · Received November 13, 2018

    Report

    Report Number
    1723170-2018-05625
    Event Type
    Malfunction
    Date Received
    November 13, 2018
    Date of Event
    November 9, 2018
    Report Date
    January 22, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169722187
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. 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

    CORRECTION: THE DATE THE NEW INFORMATION WAS RECEIVED IS 2018-12-26. 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.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF A PROCEDURE, THE NAVIGATION SYSTEM WOULD NOT DISPLAY THE MODEL OF THE INSTRUMENT IN THE APPLICATION SOFTWARE UNLESS A PROJECTION WAS ADDED TO THE INSTRUMENT. IT WAS REPORTED THAT THE INSTRUMENT COULD NOT BE VIEWED IN ORTHOGONAL VIEWS AND THAT THE INSTRUMENT MODEL WOULD NOT APPEAR WHEN THE PROJECTION WAS SET AT ZERO. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT, WHILE OUTSIDE OF A PROCEDURE, THE NAVIGATION SYSTEM WOULD NOT DISPLAY THE MODEL OF THE INSTRUMENT IN THE APPLICATION SOFTWARE UNLESS A PROJECTION WAS ADDED TO THE INSTRUMENT. IT WAS REPORTED THAT THE INSTRUMENT COULD NOT BE VIEWED IN ORTHOGONAL VIEWS AND THAT THE INSTRUMENT MODEL WOULD NOT APPEAR WHEN THE PROJECTION WAS SET AT ZERO. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE MANUFACTURER REPRESENTATIVE UPDATED AND SAID THAT THE 3D CAD MODEL WOULD DISAPPEAR IF YOU TOOK THE PROJECTION TO ZERO AND REAPPEARED IF YOU PUT A FORWARD PROJECTION ON IT. SINCE THE DOT IS SO FAINT AND HARD TO SEE, THEY USUALLY SHOW PROJECTION BUT TAKE IT TO ZERO SO THAT THEY CAN SEE THE INSTRUMENT IN THE AX/SAG/COR VIEWS BECAUSE SOME OF THE HEALTH CARE PROFESSIONALS DO NOT LIKE TO USE TRAJ 1 AND TRAJ 2. WHEN THE REP SHOWED PROJECTION AND TOOK IT TO ZERO, THE INSTRUMENT WOULD DISAPPEAR BUT WHEN THE REP MADE A FORWARD PROJECTION, IT WOULD SHOW BACK UP. IT HAPPENED A COUPLE OF TIMES BUT THE REP HAS NOT BEEN ABLE TO RECREATE IT.

    Description of Event or Problem · 1

    THE MANUFACTURER REPRESENTATIVE (REP) UPDATED AND SAID THAT THE 3D CAD MODEL WOULD DISAPPEAR IF YOU TOOK THE PROJECTION TO ZERO AND REAPPEARED IF YOU PUT A FORWARD PROJECTION ON IT. SINCE THE DOT IS SO FAINT AND HARD TO SEE, THEY USUALLY SHOW PROJECTION BUT TAKE IT TO ZERO SO THAT THEY CAN SEE THE INSTRUMENT IN THE AX/SAG/COR VIEWS BECAUSE SOME OF THE HEALTH CARE PROFESSIONALS DO NOT LIKE TO USE TRAJ 1 AND TRAJ 2. WHEN THE REP SHOWED PROJECTION AND TOOK IT TO ZERO, THE INSTRUMENT WOULD DISAPPEAR BUT WHEN THE REP MADE A FORWARD PROJECTION, IT WOULD SHOW BACK UP. IT HAPPENED A COUPLE OF TIMES BUT THE REP HAS NOT BEEN ABLE TO RECREATE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    907295 S8 STEALTHSTATION NAVIGATION SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9735665 00643169722187

    Patients

    Seq Age Sex Outcome Treatment
    1