BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2072395 · Received April 8, 2011

    Report

    Report Number
    1723170-2011-00765
    Event Type
    Malfunction
    Date Received
    April 8, 2011
    Date of Event
    March 10, 2011
    Report Date
    March 10, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SOFTWARE WAS UPGRADED AND TESTED AT SITE. A MEDTRONIC REP WAS UNABLE TO REPLICATE THE ISSUE AND REPORTED THE RESULTS WERE ACCURATE IN NAVIGATION.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED DURING A SPINE SURGERY, THEY WERE UNABLE TO ACQUIRE A NAVIGATE SPIN. THE PENDANT IS DISPLAYING A CYCLING RED X AND GREEN CHECK MARK. THE MVS CAN SUCCESSFULLY VERIFY THE IP ADDRESS OF THE STEALTHSTATION S7 IN THE DICOM SERVERS TAB. THEY HAVE GREEN STATUS IN THE SET-UP EQUIPMENT TAB IN SYNERGY SPINE 1.7. THE O-ARM TRACKER AND PT REFERENCE FRAME ARE VISIBLE AND HAVE CONSISTENT GREEN STATUS. ON THE MVS, THEY REC'D A MESSAGE AFTER THEY WERE BOTH READY AND ACTIVE (COMMUNICATION TO THE STEALTH) THAT STATED "LOST COMMUNICATION MVS UPDATE INVALID." SURGEON DISCONTINUED USE OF THE STEALTHSTATION TO COMPLETE THE SURGERY. THERE WAS NO IMPACT ON THE PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION S7 SYSTEM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. S7 NA

    Patients

    Seq Age Sex Outcome Treatment
    1