BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3040894 · Received April 8, 2013

    Report

    Report Number
    1723170-2013-00264
    Event Type
    Malfunction
    Date Received
    April 8, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 23, 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 PATIENT WEIGHT WAS NOT AVAILABLE TO THE INITIAL REPORTER. THE MEDTRONIC REP REPORTED THAT SHE NOTICED THAT THE FIDUCIALS APPEARED SYMMETRICAL ON THE PATIENT SCAN. ALSO, THAT AFTER THE CASE SHE HAD RADIOLOGY SCAN RESIN HEAD WITH FIDUCIALS AND LOADED THE EXAM ON THE SYSTEM FOR A SYSTEM CHECK. SHE SAID THAT TOUCH-N-GO AND POINTMERGE REGISTRATIONS PASSED AND WAS ACCURATE WITH BOTH REGISTRATIONS. THE REPORTED EVENT WAS NOT ABLE TO BE REPLICATED BY MEDTRONIC PERSONNEL.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT PROVIDED.

    Additional Manufacturer Narrative · 1

    THE EXAM ARCHIVE OFF OF THE SYSTEM WAS EVALUATED. THE POINTMERGE REGISTRATION LOOKED TO BE COMPLETED PROPERLY AND USED POINTS ALL OVER THE HEAD. UNABLE TO DETERMINE INACCURACY CAUSE BASED ON THE INFORMATION PROVIDED. UPON COMPLETION OF THE SOFTWARE INVESTIGATION, NO SOFTWARE FAULTS OR ANOMALIES WERE FOUND TO BE THE CAUSE OF THE ALLEGED INACCURACY.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A RIGHT FRONTAL CRANIOTOMY FOR A SUPERFICIAL TUMOR RESECTION, THEY ATTEMPTED TOUCH N' GO AND THE REGISTRATION FAILED, SO THEY REGISTERED WITH POINT MERGE. THE SURGEON INITIALLY FELT ACCURATE BEFORE GOING STERILE. UPON REMOVING THE BONE FLAP, THE SURGEON AT FIRST THOUGHT HE WAS 1 CM OFF, BUT HE CONTINUED TO NAVIGATE, AND THEN TOLD THE REP, THAT HE WAS OFF, NOT THE SYSTEM. HE FELT OFF IN THE POSTERIOR AND INFERIOR DIRECTIONS. HE CONTINUED TO NAVIGATE AND THE DOCTOR HAD NO PROBLEM FINDING AND REMOVING THE TUMOR. AFTER THE CASE, THE SURGEON CLARIFIED THAT HE THOUGHT THE SYSTEM WAS 5MM OFF. NO NEGATIVE IMPACT TO THE PATIENT OUTCOME WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143631 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR