BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION® S7

    MDR report key: 8685630 · Received June 10, 2019

    Report

    Report Number
    1723170-2019-03152
    Event Type
    Malfunction
    Date Received
    June 10, 2019
    Date of Event
    May 31, 2017
    Report Date
    June 10, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00643169505742
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AXIEM FRAME REFERENCE CABLE WAS BAD CONNECTION SO THE INSTRUMENTS COULD NOT USE. THE ISSUE WAS RESOLVED. CHECKED THE EMITER AND OTHER INSTRUMENTS, THEN SOFTWARE TEST. AXIEM FRAME REFERENCE CABLE WAS BAD CONNECTION SO THE INSTRUMENTS COULD NOT USE. AFTER CHANGE INSTRUMENTS THE TEST WAS PASSED. ALL TEST PASSED AND THE SYSTEM IS READY FOR USE. 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. IT WAS REPORTED THAT SITE COULD NOT REGISTER THE ELECTROMAGNETISM INSTRUMENT. THERE WAS NO PATIENT PRESENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478833 STEALTHSTATION® S7 INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733858 00643169505742

    Patients

    Seq Age Sex Outcome Treatment
    1