BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7

    MDR report key: 8755409 · Received July 2, 2019

    Report

    Report Number
    1723170-2019-03918
    Event Type
    Malfunction
    Date Received
    July 2, 2019
    Date of Event
    June 7, 2019
    Report Date
    September 17, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994450944
    PMA / PMN Number
    K983670
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE SOFTWARE INVESTIGATION DETERMINED THAT THE BEHAVIOR DESCRIBED IS THE INTENDED BEHAVIOR OF THE SOFTWARE. NO FAILURE WAS FOUND. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9 61579, SERIAL/LOT #: UNKNOWN. 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 SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT DURING A CLINICAL CASE THE DOCTOR WAS STATING THAT THE SYSTEM WAS INACCURATE. IT WAS NOTED THAT THE DOCTOR WAS NAVIGATING A THIRD PARTY TAP WITH MEDTRONIC SURTRACK INSTRUMENTS. THE REPRESENTATIVE WAS ABLE TO MEASURE THE INACCURACY AND IT WAS NOTICED TO BE ONLY AT 1.3 MM WELL UNDER OUR 2 MM RANGE. THE SCREW PLACEMENT WAS FINE, BUT IT LOOKED LIKE THE THIRD-PARTY INSTRUMENT WAS MAYBE DAMAGED. ALL MEDTRONIC INSTRUMENTS WERE TESTED AND PERFORMED AS INTENDED. THERE WAS NO DELAY TO THE PROCEDURE. THERE WAS NO REPORTED IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    546785 STEALTHSTATION S7 INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733856 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR