BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION® S7´

    MDR report key: 8719987 · Received June 20, 2019

    Report

    Report Number
    1723170-2019-03687
    Event Type
    Malfunction
    Date Received
    June 20, 2019
    Date of Event
    March 8, 2018
    Report Date
    June 20, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994450951
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: SYNERGY SPINE S7; I7 2.1 9733686, 510K K131425. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. IT WAS REPORTED THAT THE ISSUE COULD NOT BE CONFIRMED OR REPLICATED, NO COMPONENTS WERE REPLACED. THE HARDWARE, SOFTWARE, AND INSTRUMENTS PASSED THE SYSTEM CHECKOUT. THE SYSTEM WAS FOUND TO BE FULLY FUNCTIONAL. A VIDEO AND IMAGE OF THE ISSUE WAS RECEIVED. THE SOFTWARE INVESTIGATION WAS UNABLE TO DETERMINE PROBABLE CAUSE WITHOUT FURTHER INFORMATION SINCE THE BEHAVIOR CANNOT BE REPLICATED. 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 IN A CERVICAL SPINE PROCEDURE. IT WAS REPORTED THAT THE IMAGE WAS CENTERED IN TRAJECTORY1, TRAJECTORY2, AND AXIAL; BUT IN THE SAGITTAL VIEW THE IMAGE SHIFTED TO THE TOP LEFT POINT WHEN THE SCREW PROJECTION COULD NOT BE SEEN ON THE C2. WHEN THE SURGEON BRINGS IN THE PASSIVE PLANAR PROBE THE IMAGE IN THE SAGITTAL VIEW STAYS SHIFTED AND THE CROSSHAIRS MOVE TO THE TOP LEFT AS WELL. WHEN THE HEALTH CARE PROFESSIONAL (HCP) PUSHED THE RE-CENTER BUTTON IT RESOLVED THE ISSUE MOMENTARILY. THE HCP COULD MOVE THE IMAGE IN THE SAGITTAL VIEW TO RE-CENTER IT. THE SURGEON SET THE CROSSHAIR SETTINGS AS STATIONARY. THE SURGEON STATED THAT WHEN THE PROCEDURE WAS PLANNED THE SAGITTAL VIEW WAS SHIFTED AS WELL. THERE WAS NO DELAY TO THE PROCEDURE. NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509362 STEALTHSTATION® S7´ INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733857 00613994450951

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR