BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7

    MDR report key: 8883540 · Received August 12, 2019

    Report

    Report Number
    1723170-2019-04442
    Event Type
    Malfunction
    Date Received
    August 12, 2019
    Date of Event
    July 11, 2019
    Report Date
    August 12, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994450944
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 9734639, SERIAL/LOT #: (B)(4), UBD: UNKNOWN, UDI#: UNKNOWN. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE SYSTEM FUNCTIONED AS INTENDED. THE POWER CABLE WAS REPLACED AND THE SYSTEM THEN PASSED A SYSTEM CHECKOUT. THE POWER CABLE WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS. ANALYSIS CONFIRMED THE REPORTED ISSUE THAT THE CONNECTION CABLING/HARDWARE WAS DAMAGED. THE HARDWARE ANALYSIS FOUND THAT THE REPORTED EVENT WAS RELATED TO A HARDWARE 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 THAT, WHILE OUTSIDE OF A PROCEDURE, THE GROUND PRONG WAS BROKEN OFF THE POWER CABLE OF THE NAVIGATION SYSTEM. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED. REPLACING THE POWER CORD RESOLVED THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    676568 STEALTHSTATION S7 INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733856 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1