BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION« I7 INTEGRATED NAVIGATION SYSTEM

    MDR report key: 3243015 · Received July 23, 2013

    Report

    Report Number
    1723170-2013-00541
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ENGINEERING ANALYSIS OF SOFTWARE LOG FILES FOUND THAT THE APPLICATION LOST CONTACT WITH THE CAMERA FOR A VERY EXTENDED PERIOD OF TIME. THIS ERROR MESSAGE IS SENT APPROXIMATELY ONCE EVERY NINE SECONDS, SO THE SIZE OF THE FILE SUGGESTS THAT THE SYSTEM HAD BEEN IN NAVIGATE WHEN THE CAMERA BECAME UNRESPONSIVE, AND HAD BEEN THERE MOST LIKELY OVERNIGHT. THIS WOULD BE CONSISTENT WITH LEAVING THE CENTRAL PROCESSING UNIT RACK ON WHILE TURNING THE REST OF THE I7 ROOM OFF AT THE END OF THE DAY, AND THEN STARTING ANOTHER CASE WITHOUT LEAVING THE APPLICATION. UNABLE TO DETERMINE WHY THE SITE WAS UNABLE TO FIND THEIR REGISTRATION AFTER THE EXAM MERGE FROM AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 1

    THE SITE DECLINED TO PROVIDE PATIENT INFORMATION, REFERENCING CANADIAN PRIVACY LAWS. NO FILES OR LOGS HAVE BEEN RETURNED TO MANUFACTURER FOR EVALUATION. UNABLE TO CONFIRM COMPLAINT. SOFTWARE INVESTIGATION NOT CONDUCTED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A CRANIAL PROCEDURE, THE SITE WAS UNABLE TO FIND REGISTRATION FOLLOWING THE MERGE. THE SECOND EXAM WAS MERGED WITH THE REGISTERED EXAM. THE SITE WAS UNABLE TO GET BACK TO NAVIGATE USING THE MERGED EXAMS. IN TROUBLE-SHOOTING, WHEN ASKED IF THEY ENCOUNTERED ANY ERROR MESSAGES, THE NURSE SAID THE SURGEON PERFORMED THE MERGE. SJE WAS ASKED TP RE-SELECT THE REGISTRATION EXAM, HOWEVER AS UNSUCCESSFUL. THE SURGEON OPTED TO DISCONTINUE THE USE OF NAVIGATION TO COMPLETE THE PROCEDURE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    344336 STEALTHSTATION« I7 INTEGRATED NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. I7

    Patients

    Seq Age Sex Outcome Treatment
    1