BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3250088 · Received July 26, 2013

    Report

    Report Number
    1723170-2013-00549
    Event Type
    Malfunction
    Date Received
    July 26, 2013
    Date of Event
    June 28, 2013
    Report Date
    June 28, 2013
    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 CORRECT DATE OF (B)(4) 2013 WAS PROVIDED.

    Additional Manufacturer Narrative · 1

    SOFTWARE INVESTIGATION NOT COMPLETED AT TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    THE RETURNED LOG FILES DID NOT CONTAIN ANY CORE FILES FROM THE DATE OF THE EVENT. THE SOFTWARE INVESTIGATION FOUND THAT THE ROOT CAUSE WAS UNABLE TO BE DETERMINED WITHOUT FURTHER INFORMATION SINCE THE ON-GOING INVESTIGATION PROVED TO BE INCONCLUSIVE BASED ON THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE, THE NAVIGATION SYSTEM EXITED UNEXPECTEDLY. A RE-BOOT OF THE SYSTEM ALLOWED THEM TO RE-ENTER THE SYNERGY SPINE 2.0.1 SOFTWARE AND CONTINUE. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350411 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR