BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION® S7´

    MDR report key: 8871508 · Received August 7, 2019

    Report

    Report Number
    1723170-2019-04409
    Event Type
    Malfunction
    Date Received
    August 7, 2019
    Date of Event
    July 12, 2019
    Report Date
    September 12, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    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: 9733597, SERIAL/LOT #: (B)(4), UDI#: (B)(4). A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. IT WAS REPORTED THAT THE ISSUE WAS CONFIRMED AND THE EMITTER POWER CORD WAS 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

    CORRECTION: LOT NUMBER OF THE CABLE IS 120524. THE CABLE WAS RETURNED TO MEDTRONIC FOR ANALYSIS. IT WAS FOUND THAT THE CABLE JACKET WAS TORN AND SEPARATED AT THE LEMO CONNECTOR EXPOSING THE SHIELD WIRE BUT NO BARE CONDUCTORS. OTHERWISE, THE CABLE PASSED A CONTINUITY TEST WITH NO OPENS OR SHORTS DETECTED. THE HARDWARE INVESTIGATION 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 REGARDING A NAVIGATION SYSTEM BEING USED OUTSIDE OF A PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. DURING INSPECTION, THE EMITTER POWER/COMMUNICATION CABLE DISCONNECTED AND THE INTERNAL CORD WAS EXPOSED. POWER CABLE FRACTURE WAS CONFIRMED. THE POWER CABLE WAS REPLACED. NO COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665874 STEALTHSTATION® S7´ INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733857

    Patients

    Seq Age Sex Outcome Treatment
    1