BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    Stealthstation® S7¿

    MDR report key: 8648045 · Received May 28, 2019

    Report

    Report Number
    1723170-2019-02732
    Event Type
    Malfunction
    Date Received
    May 28, 2019
    Report Date
    May 28, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994450944
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: MODEL: 960-537, SN: UNKNOWN. 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 OF A PROCEDURE. IT WAS REPORTED THAT THE ARTICULATING ARM WAS LOCKING UP WHEN THEY TRIED TO LOOSEN IT. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441849 Stealthstation® S7¿ INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733856 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1