BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC STEALTH SURGICAL NAVIGATION SYSTEM

    MDR report key: 8894279 · Received August 13, 2019

    Report

    Report Number
    MW5089030
    Event Type
    Malfunction
    Date Received
    August 13, 2019
    Date of Event
    May 29, 2019
    Report Date
    July 31, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    MEDTRONIC SURGICAL NAVIGATION SYSTEM BEING USED FOR LUMBAR SURGERY. NOTED THAT THE INCISION WAS MADE TOO HIGH. CT IMAGE 2 SHOULD HAVE BEEN THE IMAGE CHOSEN TO BE DISPLAYED ON THE SURGEON'S MONITOR TO GUIDE THE PROCEDURE'S NAVIGATION AND PLOTTING OF THE SURGICAL INCISION. THE SKIN AND FASCIAL INCISIONS WERE CLOSED AND NEW INCISION MADE. MEDTRONIC SURGICAL NAVIGATION SYSTEMS FOR SPINAL SURGERY (S7 AND S8). THE S8 AUTOMATICALLY DISPLAYS THE NEWEST IMAGE ON TOP WHILE THE S7 DISPLAYS THE NEWEST IMAGE ON THE BOTTOM. THIS WAS FELT TO BE A CONTRIBUTING FACTOR IN THIS EVENT. INTENDED PROCEDURE COMPLETED AS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682771 MEDTRONIC STEALTH SURGICAL NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other