BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3002399 · Received March 13, 2013

    Report

    Report Number
    1723170-2013-00177
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    April 4, 2013
    Report Date
    April 4, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT WAS UNAVAILABLE FROM THE SITE AT TIME OF THIS REPORT.NO PARTS OR FILES HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    CPU HAS BEEN REPLACED ON THIS SYSTEM; SYSTEM LOGS NOT AVAILABLE. ADDITIONALLY PER EVENT SUMMARY, AFTER A REBOOT THE SYSTEM FUNCTIONED PROPERLY. UNABLE TO DETERMINE ROOT CAUSE WITHOUT FURTHER INFORMATION SINCE THE BEHAVIOR CANNOT BE REPLICATED AFTER CPU REPLACEMENT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT SYNERGY CRANIAL SOFTWARE BECAME UNRESPONSIVE DURING A PROCEDURE. THEY RE-STARTED THE SYSTEM AND THE ISSUE WAS RESOLVED, HOWEVER THE EXAMS HAD BEEN REMOVED FROM THE HARD DISK DRIVE. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE STEALTHSTATION S7 SYSTEM. THERE WAS NO NEGATIVE IMPACT ON PATIENT OUTCOME REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105555 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR