BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 4171441 · Received October 14, 2014

    Report

    Report Number
    1723170-2014-01093
    Event Type
    Malfunction
    Date Received
    October 14, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM THE SITE. A MEDTRONIC REPRESENTATIVE TESTED THE SYSTEM WITH BOTH STERILE AND UNSTERILE INSTRUMENTS. THE NAVIGATION WAS ACCURATE AND THE MEDTRONIC REPRESENTATIVE WAS UNABLE TO RECREATE REPORTED ISSUE. THE MEDTRONIC REPRESENTATIVE PERFORMED A NAVIGATION SYSTEM CHECK-OUT, ALL AREAS PASSED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A CRANIAL RESECTION PROCEDURE THE SURGEON ALLEGED THE NAVIGATION SYSTEM WAS INACCURATE. THE NAVIGATION SYSTEM WAS ACCURATE AFTER REGISTRATION, BUT AFTER DRAPING THE SURGEON ALLEGED THE SYSTEM WAS 0.5 CENTIMETERS INACCURATE. THE SURGEON STATED THE ACCURACY SEEMED WITHIN REASON WHEN NAVIGATING SUB-DURA AND OPTED TO 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
    650684 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1