BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION IOR SYSTEM

    MDR report key: 2436956 · Received January 18, 2012

    Report

    Report Number
    1723170-2012-00029
    Event Type
    Malfunction
    Date Received
    January 18, 2012
    Date of Event
    January 3, 2012
    Report Date
    January 3, 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
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SOFTWARE HAS NOT BEEN EVALUATED AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THE SURGEON ALLEGED A 4MM INACCURACY DURING A NAVIGUS BIOPSY WHEN USING THE TRACKED NEEDLE AND A MONTERIS AUTO LIT WAND. THE SURGEON WAS 4MM POSTERIOR TO THE TARGET WITH BOTH INSTRUMENTS. THEY RE-SET THEN LOCKED THE TRAJECTORY WHICH ENABLED THEM TO PROCEED AND COMPLETE THE CRANIAL SURGERY WITH THE USER OF THE STEALTHSTATION. THERE WAS NO IMPACT ON PATIENT OUTCOME. THERE WERE NO FURTHER ISSUES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR