BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3230225 · Received July 16, 2013

    Report

    Report Number
    1723170-2013-00521
    Event Type
    Malfunction
    Date Received
    July 16, 2013
    Date of Event
    June 17, 2013
    Report Date
    June 17, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SOFTWARE INVESTIGATION COMPLETED. THIS ISSUE WILL BE CONTINUALLY MONITORED IN A MEDTRONIC SOFTWARE ANOMALY TRACKING DATABASE. IN ADDITION TO THE SYSTEM PERFORMANCE TESTING A MEDTRONIC REPRESENTATIVE PERFORMED EARLIER, HE ALSO STANDARDIZED THE SURGEON PROFILES AS THERE WERE DIFFERENCES IN THE SETTINGS. SOME OF THE PROFILES WERE SET FOR RADIOGRAPHIC VIEW, WHILE OTHER PROFILES WERE SET FOR STANDARD VIEW. THESE PROFILE DIFFERENCES COULD BE THE REASON IT APPEARED THE IMAGES "FLIPPED". THE ISSUE HAS NOT RECURRED SINCE THE PROFILES WERE STANDARDIZED.

    Additional Manufacturer Narrative · 1

    THE SITE DECLINED TO PROVIDE PATIENT INFORMATION, REFERENCING (B)(4) PRIVACY LAWS. MEDTRONIC REPRESENTATIVE FOLLOWING-UP AT THE SITE, PERFORMED A SYSTEM CHECK-OUT TO OBSERVE CRANIAL CASE IN MRT. ORIENTATION APPEARS CORRECT PER PATIENT EXAM. TESTED WORKFLOW TO ENSURE IMAGE FLIPPING NOT CAUSED BY STEALTHSTATION S7 SYSTEM OR CRANIAL APPLICATION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A CRANIAL PROCEDURE, THE SURGEON ALLEGED THAT ALTHOUGH THE FIDUCIALS WERE PLACED IN AN ASYMMETRIC FASHION, THE IMAGES FLIPPED LEFT/RIGHT AFTER REGISTRATION. A SECOND NAVIGATION SYSTEM WAS BROUGHT IN TO COMPLETE THE SURGERY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    329807 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1