BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION® S7

    MDR report key: 8720231 · Received June 20, 2019

    Report

    Report Number
    1723170-2019-03691
    Event Type
    Malfunction
    Date Received
    June 20, 2019
    Date of Event
    February 14, 2018
    Report Date
    June 20, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. UDI NOT AVAILABLE FOR THIS SYSTEM AT TIME OF FILING. DEVICE MANUFACTURING DATE IS UNAVAILABLE. NO PARTS HAVE BEEN RECEIVED BY THE MANUFACTURER FOR EVALUATION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION REGARDING NAVIGATION SYSTEM WHILE OUTSIDE OF PROCEDURE. IT WAS REPORTED THAT THE POLARIS SPECTRA SYSTEM CONTROL UNIT (SCU) TO POSITIONING SENSOR UNIT (PSU) CABLE WAS DAMAGED. THERE WAS NO PATIENT PRESENT WHEN THE ISSUE OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    511390 STEALTHSTATION® S7 INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733858

    Patients

    Seq Age Sex Outcome Treatment
    1