BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION® I7¿ INTEGRATED NAVIGATION SYSTEM

    MDR report key: 2803281 · Received October 24, 2012

    Report

    Report Number
    1723170-2012-00594
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    September 28, 2012
    Report Date
    September 28, 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

    IT WAS REPORTED THAT THE SURGEON USED LARGE RETRACTORS AND THAT THE RETRACTORS LIKELY SHIFTED THE PATIENT'S HEAD IN THE MAYFIELD PINS AFTER REGISTRATION. THIS WOULD CAUSE THE SPATIAL RELATIONSHIP BETWEEN THE REFERENCE FRAME AND THE PATIENT TO CHANGE, THEREBY MAKING THE REGISTRATION INVALID.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A CRANIAL PROCEDURE, THE SURGEON ALLEGED NAVIGATION WAS 1CM INACCURATE SUPERIOR/INFERIOR. PATIENT WAS IN THE PRONE POSITION. POINTMERGE WAS USED TO REGISTER THE PATIENT. THE SURGEON CONFIRMED ACCURACY AFTER REGISTRATION AND AFTER POST-DRAPING THE PATIENT. THE STAFF DID NOT BELIEVE THE REFERENCE FRAME, OR ARM, MOVED AFTER DRAPING THE PATIENT. THE SURGEON OPTED TO DISCONTINUE NAVIGATION TO COMPLETE THE PROCEDURE. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 17 YR