BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2062352 · Received March 18, 2011

    Report

    Report Number
    1723170-2011-00680
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 23, 2011
    Report Date
    February 23, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SOFTWARE EVALUATION IS IN-PROGRESS AT THE TIME OF THIS REPORT. SITE EVALUATION SHOWED THAT WHEN THE SITE USED TOUCH N GO, THE 3D MODEL WAS NOT BUILT CORRECTLY. CASS TRAINED SITE ON HOW TO DO 3D MODEL BUILDING INCLUDING CORRECT FIDUCIAL PLACEMENT.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT WHILE IN A CRANIAL CASE, THEY HAD TRIED TO REGISTER WITH TOUCH-N-GO BUT WERE GETTING A REGISTRATION THAT WAS APPROXIMATELY 6 INCHES INACCURATE. WHEN THE SITE REPRESENTATIVE CALLED, THEY HAD ALREADY PROCEEDED TO TRY TO REGISTER WITH POINTMERGE BUT WERE HAVING TROUBLE REGISTERING BECAUSE THE POINTS THEY WERE TOUCHING WERE NOT STORING. THEY WERE USING SYNERGY CRANIAL/OPTICAL. MEDTRONIC TECHNICAL SERVICES FOUND THAT THEY WERE TRYING TO COMPLETE POINTMERGE USING THE TOUCH-N-GO PROBE AND DIRECTED THE SITE TO SWITCH TO THE PASSIVE PLANAR BLUNT. THE SITE REPRESENTATIVE VERIFIED THE PROBE AND WAS ABLE TO PROCEED WITH A PREDICTED ACCURACY OF 2.2. SURGEON CONTINUED THE SURGERY WITH THE USE OF THE STEALTHSTATION. THERE WAS NO IMPACT ON THE PATIENT OUTCOME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR