BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3002434 · Received March 13, 2013

    Report

    Report Number
    1723170-2013-00179
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 13, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SOFTWARE INVESTIGATION FOUND THAT THE ROOT CAUSE WAS UNABLE TO BE DETERMINED WITHOUT FURTHER INFORMATION SINCE THERE WERE AT LEAST THREE DOCUMENTED ATTEMPTS MADE TO RETRIEVE LOGS WITH NO ADDITIONAL INFORMATION MADE AVAILABLE. NO FURTHER INVESTIGATION COULD BE PERFORMED.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT PROVIDED AS SITE DECLINED, QUOTING THE CANADIAN PRIVACY REGULATION. SOFTWARE INVESTIGATION NOT COMPLETED AT TIME OF THIS REPORT.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SPINE PROCEDURE, USING NAVIGATION WITH THE 2D C-ARM TRACKER, IMAGES APPEARED ACCURATE AT THE BEGINNING OF THE PROCEDURE. WHEN VERIFYING THE LOCATION OF HARDWARE DURING LIVE FLUORO, THE SYSTEM WAS ALLEGED TO BE INACCURATE. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF THE STEALTHSTATION S7 SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106134 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1