BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 7263656 · Received February 12, 2018

    Report

    Report Number
    1723170-2018-00637
    Event Type
    Malfunction
    Date Received
    February 12, 2018
    Date of Event
    January 22, 2018
    Report Date
    June 16, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC. (LOUISVILLE)
    Product Code
    HAW
    UDI-DI
    00613994450944
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. THE REPRESENTATIVE WAS UNABLE TO REPLICATE THE REPORTED ISSUE. THE HARDWARE, SOFTWARE, AND INSTRUMENTS PASSED THE SYSTEM CHECKOUT. THE SYSTEM WAS FOUND TO BE FULLY FUNCTIONAL.

    Additional Manufacturer Narrative · 1

    THE SOFTWARE INVESTIGATION FOUND THAT THE REPORTED EVENT WAS RELATED TO A SOFTWARE ISSUE. THIS ISSUE WAS DOCUMENTED IN A NAVIGATION SOFTWARE ANOMALY TRACKING DATABASE.

    Additional Manufacturer Narrative · 1

    THE LOGS FOR THE NAVIGATION SYSTEM WERE REVIEWED BY MEDTRONIC PERSONNEL. HOWEVER, THE LOGS PROVIDED NO ADDITIONAL INSIGHT INTO THE PROBABLE CAUSE OF THE ANOMALY.

    Additional Manufacturer Narrative · 1

    FDC CODE UPDATED WITH THE CORRECT INFORMATION. SOFTWARE 9735585 STEALTHSTATION CRANIAL; UPN (B)(4); 510K K153660. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT, WHILE OUTSIDE OF A PROCEDURE, THE NAVIGATION SYSTEM BECAME UNRESPONSIVE WHEN SELECTING A PROCEDURE IN THE APPLICATION SOFTWARE. IT WAS REPORTED THAT THE BUTTONS WERE UNRESPONSIVE TO PROMPTS FROM THE USER. IT WAS REPORTED THAT EXITING THE APPLICATION SOFTWARE LED TO THE REPRESENTATIVE BEING UNABLE TO RE-ENTER THE SOFTWARE. SHUTTING DOWN THE NAVIGATION SYSTEM VIA THE POWER BUTTON DID NOT RESTORE FUNCTIONALITY. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    108504 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. (LOUISVILLE) S7 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1