BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM

    MDR report key: 4013625 · Received August 15, 2014

    Report

    Report Number
    1723170-2014-00861
    Event Type
    Malfunction
    Date Received
    August 15, 2014
    Date of Event
    July 22, 2014
    Report Date
    July 22, 2014
    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

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. SOFTWARE INVESTIGATION COMPLETED, SOFTWARE IS FUNCTIONING AS DESIGNED. RMA ISSUED. REPLACEMENT COMPUTER SHIPPED TO SITE (B)(4) 2014. NO HDD OR RAM ERRORS REPORTED. (B)(4) 2014 A MEDTRONIC REPRESENTATIVE PERFORMED A NAVIGATION SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED.

    Additional Manufacturer Narrative · 1

    THE I/O HUB WAS REPLACED ON THE SYSTEM. SYSTEM TESTED FULLY FUNCTIONAL AFTER REPLACEMENT OF I/O HUB. THE SUSPECT SYSTEM I/O HUB WAS RETURNED AND EVALUATED. NO FAULT WAS FOUND. THE UNIT TESTED FULLY FUNCTIONAL ON ALL PORTS. AFTER REPLACEMENT OF THE I/O HUB AND THE COMPUTER NO FURTHER RELATED SUBSEQUENT ISSUES HAVE RECURRED.

    Additional Manufacturer Narrative · 1

    ENGINEERING REVIEW OF THE SYSTEM ERROR LOGS FOUND MULTIPLE I/O HUB ERRORS. A REPLACEMENT I/O HUB HAS BEEN SENT TO THE SITE FOR ISSUE RESOLUTION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE RECEIVED A REPORT FROM A SITE THAT THEIR NAVIGATION SYSTEM BECAME UNRESPONSIVE AFTER SWITCHING INTO THE SELECT PATIENT SCREEN. SYNERGY CRANIAL APPLICATION EXITED AND THEN RE-ENTERED JUST PRIOR TO THIS OCCURRING. IT WAS NOTED THAT THE SYSTEM HAD BEEN LEFT ON OVERNIGHT, AT THE NAVIGATE SCREEN. IN TROUBLE-SHOOTING, A SYSTEM RE-BOOT RESTORED NORMAL FUNCTIONALITY. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489412 STEALTHSTATION I7 INTEGRATED NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. I7

    Patients

    Seq Age Sex Outcome Treatment
    1