BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM

    MDR report key: 3891259 · Received June 24, 2014

    Report

    Report Number
    1723170-2014-00672
    Event Type
    Malfunction
    Date Received
    June 24, 2014
    Date of Event
    May 26, 2014
    Report Date
    May 26, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. RMA ISSUED. REPLACEMENT COMPUTER SHIPPED TO SITE (B)(4) 2014. ON (B)(4) 2014 A MEDTRONIC REPRESENTATIVE PERFORMED A NAVIGATION SYSTEM CHECK-OUT. COMPUTER REPLACED. SOFTWARE ICONS VISIBLE, AXIEM AND POLESTAR RUNNING PROPERLY. ISSUE RESOLVED. SYSTEM WORKING CORRECTLY. SUSPECT COMPUTER HAS NOT BEEN RETURNED TO MANUFACTURER FOR ANALYSIS.

    Additional Manufacturer Narrative · 1

    SOFTWARE INVESTIGATION COMPLETED. THIS ISSUE WILL BE CONTINUALLY MONITORED IN A MEDTRONIC SOFTWARE ANOMALY TRACKING DATABASE. ISSUE WAS RESOLVED WITH A NEW COMPUTER, SUSPECT INTERMITTENT USB SUBSYSTEM PROBLEM. THE SUSPECT COMPUTER WAS RETURNED, WOULD NOT BOOT PROPERLY AND DISPLAYED AN ERROR MESSAGE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN AN EAR, NOSE & THROAT (ENT) PROCEDURE, THE SITE ALLEGED AN ERROR IN THE AXIEM ENT SOFTWARE APPLICATION. A COMMUNICATION FAILURE WAS DETECTED AND REQUIRED THE SITE TO LOG-OUT TO RE-ESTABLISH CONNECTION. WHEN THIS WAS ACCOMPLISHED, ALL PATIENT AND REGISTRATION DATA WAS SAVED. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368238 STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. I7

    Patients

    Seq Age Sex Outcome Treatment
    1