BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2872910 · Received December 13, 2012

    Report

    Report Number
    1723170-2012-00708
    Event Type
    Malfunction
    Date Received
    December 13, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 15, 2012
    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

    DUE TO CHARACTER LIMITATIONS THE COMPLETE PATIENT IDENTIFIER IS DOCUMENTED HERE (B)(6). SOFTWARE HAS NOT BEEN EVALUATED AS OF THE DATE OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    EXAM ANALYSIS FINDS THE GREEN SPHERE OF ACCURACY IS APPROX 8CM IN DIAMETER. THE YELLOW SPHERE OF ACCURACY IS APPROX 15CM, ENCOMPASSING ABOUT 90% OF THE BRAIN. THERE IS NO REASON TO EXPECT THIS REGISTRATION WOULD RESULT IN AN INACCURACY OF AMOUNT ALLEGED IN THE SUMMARY. IT IS MORE LIKELY THE FRAME MOVED WHEN GOING FROM NONSTERILE TO STERILE. SINCE WE DON'T KNOW THIS FOR SURE, THERE IS INSUFFICIENT INFORMATION TO DRAW A CONCLUSION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING THE TUMOR RESECTION THE SURGEON ALLEGED AN INACCURACY AFTER GOING STERILE. REGISTRATION WAS DONE USING POINTMERGE AND HAD A 2.5 SPHERE OF ACCURACY. THE DOCTOR STATED THAT HE WAS 1CM LATERAL AND 1 CM SUPERIOR INACCURATE; HOWEVER, CONTINUED THE CASE WITH THE USE OF NAVIGATION WHILE ACCOUNTING FOR THE INACCURACY. THE PROCEDURE WAS COMPLETED WITH NO NEGATIVE IMPACT TO THE PATIENT OUTCOME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR