BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S8 PREMIUM SYSTEM

    MDR report key: 8923835 · Received August 22, 2019

    Report

    Report Number
    1723170-2019-04611
    Event Type
    Malfunction
    Date Received
    August 22, 2019
    Date of Event
    August 6, 2019
    Report Date
    October 3, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735821, SERIAL/LOT #: UNKNOWN, UBD: UNKNOWN, UDI#: UNKNOWN. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT PARTS WERE REPLACED. THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: LOT NUMBER FOR PRODUCT ID: 9735821 IS P901711. THE PSU WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. ANALYSIS FOUND THAT THE REPORTED ISSUE COULD BE CONFIRMED. A CHECK OF THE LOGS FOUND A FIRMWARE INCOMPATIBILITY ISSUE AND A BUMP AND TEMPERATURE FAILURE. THE PSU ALSO FAILED AN ACCURACY TEST. ANALYSIS FOUND THAT THE REPORTED EVENT WAS RELATED TO AN ELECTRICAL ISSUE. THIS ISSUE WAS DOCUMENTED IN A MEDTRONIC NAVIGATION HARDWARE ANOMALY TRACKING DATABASE. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING A NAVIGATION SYSTEM. IT WAS REPORTED THAT THE POSITIONING SENSOR UNIT (PSU) COULD NOT BE RECOGNIZED BY THE BUMP OF PSU AND THE TEMPERATURE SENSOR DETECTION. THE ISSUE WAS RESOLVED AFTER REPLACING WITH A BACK-UP PRODUCT. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. AN UPDATE WAS PROVIDED THE ISSUE RESOLVED BY REPLACING THE PSU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714087 STEALTHSTATION S8 PREMIUM SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9735665

    Patients

    Seq Age Sex Outcome Treatment
    1