BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3043045 · Received April 9, 2013

    Report

    Report Number
    1723170-2013-00263
    Event Type
    Malfunction
    Date Received
    April 9, 2013
    Date of Event
    March 11, 2013
    Report Date
    March 11, 2013
    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

    THE MEDTRONIC REPRESENTATIVE REPORTED THAT HE PERFORMED A SYSTEM CHECK AT THE SITE USING THE SAW BONES MODEL. HE TESTED THE AWL TIP, 5.5MM TAP, AND THE THORACIC AWL INSTRUMENTS AND THEY WERE ALL ACCURATE. HE ALSO ACQUIRED SCANS OF THE SAW BONES MODEL AND WAS ABLE TO ACCURATELY NAVIGATE USING THE SCANS AND MULTIPLE INSTRUMENTS. THE REPORTED EVENT WAS NOT ABLE TO BE DUPLICATED BY MEDTRONIC PERSONNEL. THE SITE HAS DONE SUCCESSFUL CASES SINCE THIS ISSUE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THE SITE WAS 2 MM INACCURATE DURING A TWO LEVEL FUSION CASE WITH FLUORO NAV. THEY HAD TO MANUALLY ACQUIRE THE IMAGES, BUT OTHER THAN THAT THEY HAD NO ISSUE ACTIVATING IMAGES. THE SURGEON WAS ABLE TO SUCCESSFULLY COMPLETE THE CASE USING THE NAVIGATION SYSTEM. THERE WAS NO NEGATIVE IMPACT TO THE PATIENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145299 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR