BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION IOR SYSTEM

    MDR report key: 2257775 · Received August 29, 2011

    Report

    Report Number
    1723170-2011-01340
    Event Type
    Malfunction
    Date Received
    August 29, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 5, 2011
    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

    THERE WERE NO ISSUES FOUND WITH THE SOFTWARE. THE SITE BELIEVED THAT THE SCRUB TECH MAY HAVE BUMPED THE FRAME DURING SURGERY. THEY HAVE DONE MULTIPLE SUCCESSFUL CASES SINCE WITH NO FURTHER ISSUES.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED A NAVIGATIONAL INACCURACY OF ABOUT 1CM IN THE CRANIAL PORTION OF A TRANSSPHENOIDAL CASE. THEY WERE USING MACH CRANIAL AND HAD DONE THE ENT PORTION OF THE CASE ACCURATELY AND WITHOUT ISSUE. AT SOME POINT AFTER REACHING THE TUMOR THEY NOTICED THAT NAVIGATION WAS NO LONGER ACCURATE. THEY ABORTED NAVIGATION AT THIS POINT BUT CONTINUED THE CASE WITH A SUCCESSFUL OUTCOME. THERE WAS NO IMPACT TO THE PT.

    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 66 YR