BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3131789 · Received May 29, 2013

    Report

    Report Number
    1723170-2013-00383
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT UNAVAILABLE FROM SITE AT TIME OF THIS REPORT. A MEDTRONIC REPRESENTATIVE AT THE SITE, FOUND THE VERTEK ARM WAS ABLE TO BE TIGHTENED AND HOLD IN PLACE PROPERLY; FULLY FUNCTIONAL. SOFTWARE INVESTIGATION COMPLETED. FINDINGS ARE THAT SOFTWARE ENGINEERS WERE UNABLE TO DETERMINE ROOT CAUSE AS THE REPORTED BEHAVIOR COULD NOT BE REPLICATED. THE SURGEON NOTED THE FRAME COULD HAVE BEEN PLACED IMPROPERLY OR THE VERTEK ARM MAY HAVE MOVED DURING DRAPING. THE RE-SCHEDULED CASE WAS SUCCESSFUL.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT A SURGEON ALLEGED AN INACCURACY, WHILE IN A TUMOR RESECTION, USING SYNERGY CRANIAL. TRACER REGISTRATION PASSED AND ACCURACY WAS VERIFIED. AFTER REMOVING THE UNSTERILE FRAME, DRAPING AND PUTTING ON THE STERILE FRAME, THE BONE FLAP WAS REMOVED BEFORE CHECKING ACCURACY AGAIN. AFTER TAKING OFF THE BONE FLAP, THE PASSIVE PLANAR BLUNT WAS USED, THE SURGEON TOUCHED THE BONE AND THE POINTER SHOWED DEEP INSIDE THE SKULL (A MILLIMETER MEASUREMENT COULD NOT BE GIVEN). IT WAS NOTED THAT SOMETIMES WHEN TRYING TO TRACK THE PROBE, THE 2D IMAGES DID NOT APPEAR IN THEIR QUADRANTS. THE SURGEON OPTED TO DISCONTINUE THE USE OF NAVIGATION AND RE-SCHEDULED THE PROCEDURE FOR THE FOLLOWING DAY. THERE WAS NO HARM TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    234723 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death