BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION® S7

    MDR report key: 9395043 · Received December 2, 2019

    Report

    Report Number
    1723170-2019-05823
    Event Type
    Malfunction
    Date Received
    December 2, 2019
    Date of Event
    November 26, 2019
    Report Date
    March 3, 2020
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169505742
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735340R, SERIAL/LOT #: (B)(4), UDI#: UNKNOWN. A MEDTRONIC REPRESENTATIVE WENT TO THE SITE TO TEST THE EQUIPMENT. TESTING REVEALED THAT THE SCU HAD POWER BUT WAS UNRESPONSIVE. THE SCU WAS REPLACED AND FUNCTION RESTORED. THE SYSTEM THEN PASSED THE SYSTEM CHECKOUT AND WAS FOUND TO BE FULLY FUNCTIONAL. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE POLARIS SPECTRA SYSTEM CONTROL UNIT (SCU) WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. TESTING FOUND THAT THE SCU WOULD NOT POWER ON AND THAT A FUSE HAD BLOWN. 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 DEVICE BEING USED OUTSIDE A PROCEDURE. IT WAS REPORTED THAT THE CAMERA WAS UNRESPONSIVE ON THE STEALTHSTATION IN CRANIAL AND SPINE APPLICATIONS. DURING TESTING IT WAS FOUND THAT THE SCU HAD POWER BUT WAS UNRESPONSIVE. THE SCU WAS REPLACED AND FUNCTION RESTORED. THERE WAS NO PATIENT PRESENT WHEN THIS ISSUE WAS IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1193042 STEALTHSTATION® S7 INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733858 00643169505742

    Patients

    Seq Age Sex Outcome Treatment
    1