BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3201151 · Received July 2, 2013

    Report

    Report Number
    1723170-2013-00492
    Event Type
    Malfunction
    Date Received
    July 2, 2013
    Date of Event
    June 5, 2013
    Report Date
    June 5, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SEX WAS PROVIDED. ALL OTHER DEMOGRAPHICS WERE NOT AVAILABLE PER HOSPITAL POLICY.

    Additional Manufacturer Narrative · 1

    THE SOFTWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A SOFTWARE ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION SOFTWARE ANOMALY TRACKING DATABASE. A NEW VERSION OF THE SOFTWARE WAS INSTALLED AT THE SITE TO RESOLVE THE ISSUE.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT AVAILABLE FROM THE SITE AT THE TIME OF THIS REPORT. SOFTWARE INVESTIGATION NOT COMPLETED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A PROCEDURE, THE NAVIGATION SYSTEM BECAME UNRESPONSIVE ONLY IN SYNERGY CRANIAL 2.2.5 SOFTWARE. THE SYSTEM WAS RE-BOOTED AND RETURNED TO PROPER FUNCTIONING. THE SURGEON OPTED TO COMPLETE THE PROCEDURE WITHOUT THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301616 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1