BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2803243 · Received October 24, 2012

    Report

    Report Number
    1723170-2012-00584
    Event Type
    Malfunction
    Date Received
    October 24, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 1, 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
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SITE DECLINED TO PROVIDE PATIENT DEMOGRAPHIC INFORMATION. NO PARTS OR FILES HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION AT TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    THE SMALL PASSIVE CRANIAL REFERENCE FRAME WAS RETURNED TO THE MANUFACTURER AND MOUNTED TO A VERTEK ARM, WITH MARKERS ATTACHED AND FULLY SEATED, THE FRAME RETURNED GOOD GEOMETRY AND DIVOT ERROR READINGS. NO PROBLEM FOUND.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT WHILE IN A CRANIAL PROCEDURE, THE SURGEON WAS APPROXIMATELY 2MM INACCURATE AFTER THEY ATTACHED THE STERILE PATIENT REFERENCE FRAME POST-REGISTRATION. IT WAS REPORTED THAT THE NON-STERILE PATIENT REFERENCE FRAME WAS USED WITH A NEW STYLE VERTEK ARM FOR REGISTRATION, AND THE FRAME DID NOT FULLY SEAT ON THE VERTEK ARM. THE REFERENCE FRAME WAS OLDER, AND THE SURGEON COULD NOT TELL IF THE PIN ON THE BACK OF THE FRAME WAS DAMAGED. AFTER REGISTRATION, A NEWER PATIENT REFERENCE FRAME WAS ATTACHED AND FULLY SEATED ON THE VERTEK ARM. THE SURGEON FELT INACCURATE BY 2 MM SUPERIOR/INFERIOR. NAVIGATION WAS CONTINUED TO COMPLETE THE PROCEDURE. THERE WAS NO IMPACT TO THE PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1