BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3953117 · Received July 23, 2014

    Report

    Report Number
    1723170-2014-00795
    Event Type
    Malfunction
    Date Received
    July 23, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 2, 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

    RMAS ISSUED. REPLACEMENT 4-PORT VGA SPLITTER AND DVI-M TO HD15-F SHORT CABLE SHIPPED TO SITE (B)(4) 2014. RMA ISSUED. REPLACEMENT ADAPTER DVI CABLE SHIPPED TO SITE (B)(4) 2014. NO PARTS HAVE BEEN RETURNED TO MANUFACTURER FOR ANALYSIS. THESE IS NO INDICATION REPLACEMENT PARTS WERE NEEDED OR USED. A MEDTRONIC REPRESENTATIVE PERFORMED A NAVIGATION SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE RECEIVED A REPORT FROM THE SITE STEALTH COORDINATOR, THAT WHILE IN A CEREBRO-VASCULAR PROCEDURE, THE STAFF AND SURGEON MONITORS WERE DISPLAYING UNEXPECTED BEHAVIOR. THE SITE REPRESENTATIVE REPORTED THAT BOTH MONITORS WERE DISPLAYING THE TOP PART OF THE SCREEN AS BLUE AND THE BOTTOM PART AS BLACK AND FLICKERING. THIS ANOMALY WAS NOTED WHEN THEY WERE STARTING TO USE THE NAVIGATION SYSTEM FOR A SURGERY AND THE PATIENT WAS IN THE OPERATING ROOM (OR) UNDER ANESTHESIA. TROUBLE-SHOOTING DID NOT RESOLVE THE ISSUE. A SECOND NAVIGATION SYSTEM WAS BROUGHT IN TO CONTINUE THE PROCEDURE. 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
    430995 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR