BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3140684 · Received May 31, 2013

    Report

    Report Number
    1723170-2013-00393
    Event Type
    Malfunction
    Date Received
    May 31, 2013
    Date of Event
    May 6, 2013
    Report Date
    May 6, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CORRECTIONS: ADVERSE EVENT INADVERTENTLY SELECTED ON THE INITIAL 3500A, CORRECTED TO PRODUCT PROBLEM. EVALUATION: THE SOFTWARE INVESTIGATION FOUND THAT THERE WAS ONLY A SINGLE EXAM THAT WAS REGISTERED WITH TRACER. THERE IS NO INDICATION THAT A MERGE WAS PERFORMED. THE ROOT CAUSE WAS UNABLE TO BE DETERMINED WITHOUT FURTHER INFORMATION SINCE THE ON-GOING INVESTIGATION PROVED TO BE INCONCLUSIVE BASED ON THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    A MEDTRONIC REPRESENTATIVE, FOLLOWING UP AT THE SITE, PERFORMED A SYSTEM CHECKOUT. NO INACCURACY WAS FOUND. SYSTEM FULLY FUNCTIONAL. HEAD FRAME HAS BEEN TESTED AND LITTLE SLACK ON LOCKING MECHANISM HAS BEEN DISCOVERED. SOFTWARE INVESTIGATION HAS NOT BEEN COMPLETED.

    Description of Event or Problem · 1

    A SURGEON REPORTED AN INACCURACY OF 1-2CM THAT OCCURRED WHILE IN A CRANIAL PROCEDURE. THE BONE FLAP NEEDED TO BE ENLARGED AND THE LINEAR SKIN EXCISION EXTENDED 3-4CM. NAVIGATION WAS CONTINUED UNTIL THE TUMOR WAS LOCALIZED VISUALLY. THE PROCEDURE WAS COMPLETED 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
    242108 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR