BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    S7 STEALTHSTATION

    MDR report key: 8685470 · Received June 10, 2019

    Report

    Report Number
    1723170-2019-03142
    Event Type
    Malfunction
    Date Received
    June 10, 2019
    Date of Event
    September 11, 2017
    Report Date
    June 10, 2019
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: MODEL: 9730605, SERIAL/LOT: 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 FOR A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SITE WAS INACCURATE IMMEDIATELY AFTER AN IMAGING SYSTEM SPIN. THE SITE WAS USING A PERK PIN AND MAY HAVE BUMPED THE FRAME. THE SITE RE-SPUN AND WAS ABLE TO CONTINUE. THERE WAS LESS THEN AN HOUR DELAY TO THE PROCEDURE. THERE WAS NO IMPACT ON THE PATIENT¿S OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478416 S7 STEALTHSTATION INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733927

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR