BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTH S7

    MDR report key: 8188324 · Received December 20, 2018

    Report

    Report Number
    1723170-2018-06401
    Event Type
    Malfunction
    Date Received
    December 20, 2018
    Date of Event
    November 2, 2017
    Report Date
    December 20, 2018
    Manufacturer
    MEDTRONIC NAVIGATION, INC
    Product Code
    HAW
    UDI-DI
    00613994450944
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS UNAVAILABLE FROM SITE. A MANUFACTURER REPRESENTATIVE WENT TO THE SITE TO TEST THE NAVIGATION SYSTEM. THE SYSTEM PERFORMED AS INTENDED AND NO PARTS WERE REPLACED. A SOFTWARE INVESTIGATION ANALYSIS WAS INITIATED TO DETERMINE THE PROBABLE CAUSE OF THE ISSUE. THE ANALYSIS WAS INCONCLUSIVE AND PROBABLE CAUSE WAS UNABLE TO BE DETERMINED. 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 INTRA-OPERATIVELY DURING A SACROILIAC AND THORACOLUMBAR PROCEDURE. IT WAS REPORTED THAT THE SYSTEM WAS DISPLAYING ODD INSTRUMENT BEHAVIOR. WHEN NAVIGATING WITH THE PROBE, THE DOCTOR ASKED FOR A PROJECTION AND ONCE THE PROJECTION WAS CREATED, IT WOULD REMOVE THE PROJECTION ONCE HE RESUMED NAVIGATION. THE SYSTEM CONTAINED 150+ PATIENTS. THE ISSUE EXTENDED THE SURGICAL TIME BY LESS THAT 1 HOUR. THERE WAS NO IMPACT TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1023764 STEALTH S7 INSTRUMENT, STEREOTAXIC HAW MEDTRONIC NAVIGATION, INC 9733856 00613994450944

    Patients

    Seq Age Sex Outcome Treatment
    1