BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S8 SYSTEM

    MDR report key: 11236125 · Received January 27, 2021

    Report

    Report Number
    1723170-2021-00226
    Event Type
    Malfunction
    Date Received
    January 27, 2021
    Date of Event
    January 21, 2021
    Report Date
    January 27, 2021
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K162309
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 9735821, SERIAL/LOT #: P9-00710, UBD: UNKNOWN, UDI#: UNKNOWN.THIS EVENT TOOK PLACE IN INDIA. A MEDTRONIC REPRESENTATIVE VISITED THE SITE TO EVALUATE THE EQUIPMENT. HARDWARE PARTS WERE REPLACED. CODES B01, C02, AND D02 ARE APPLICABLE. NO OTHER PRODUCTS HAVE BEEN RETURNED TO MEDTRONIC FOR ANALYSIS. CODES B17, C20, AND D15 ARE APPLICABLE. 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 THERE WAS A "LOCALIZER NOT CONNECTED" ERROR MESSAGE ON THE DISPLAY. THIS WAS REPORTED OUTSIDE OF A PROCEDURE. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    131654 STEALTHSTATION S8 SYSTEM INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9735665

    Patients

    Seq Age Sex Outcome Treatment
    1