BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3913301 · Received July 3, 2014

    Report

    Report Number
    1723170-2014-00719
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Date of Event
    June 10, 2014
    Report Date
    June 10, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO PATIENT INVOLVED WITH THIS CONCERN. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER. THE VA HOSPITAL WILL REPORTEDLY NOT BE SENDING THE HARD DRIVE BACK. THE HARD DRIVE WILL BE DESTROYED ACCORDING TO THE VA PROTOCOL.

    Additional Manufacturer Narrative · 1

    THE SOFTWARE ANALYSIS OF THE LOG-FILES DID NOT CONTAIN ANYTHING RELEVANT TO THE SYMPTOMS CALLED OUT IN THE REPORTED EVENT. IN ADDITION, THE COMPUTER'S HARD DRIVE WAS REMOVED BY THE SITE PRIOR TO RETURN TO MANUFACTURER FOR EVALUATION. THE INVESTIGATION WAS UNABLE TO DETERMINE A PROBABLE CAUSE WITHOUT FURTHER INFORMATION SINCE THE ON-GOING INVESTIGATION PROVED TO BE INCONCLUSIVE BASED ON THE INFORMATION PROVIDED. A SITE REPRESENTATIVE REPORTED THAT THE SYSTEM WAS FULLY FUNCTIONAL WITH THE REPLACEMENT COMPUTER.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE SYSTEM BECAME UNRESPONSIVE AFTER SELECTING THE EDIT 3D MODEL BUTTON WITHIN THE PLAN PAGE OF THE CRANIAL APPLICATION. THE SYSTEM DID NOT RESPOND TO SOFTWARE REBOOT. HE HARD BOOTED THE SYSTEM WAS ABLE TO EDIT MODEL WITHIN THE CRANIAL APPLICATION AS EXPECTED. HE NOTED THAT THE SYSTEM WAS ALSO RUNNING SLOWER THAN EXPECTED. THE ISSUE WAS DETECTED OUTSIDE OF SURGERY WITH NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389173 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1