BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2012232 · Received February 2, 2011

    Report

    Report Number
    1723170-2011-00076
    Event Type
    Malfunction
    Date Received
    February 2, 2011
    Date of Event
    January 5, 2011
    Report Date
    January 5, 2011
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFORMATION NOT AVAILABLE AS HOSPITAL DECLINED TO PROVIDE PT DEMOGRAPHICS. THE SOFTWARE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE FLUORO PROCEDURE APPLICATION EXITED TWICE WHILE IN A SPINE CASE. THE SECOND TIME OCCURRED DURING NAVIGATION, AND REQUIRED A HARD SHUT DOWN OF THE SYSTEM. THEY RE-SCANNED THE PT AND THE SURGEON COMPLETED THE SURGERY USING THE STEALTHSTATION WITH NO IMPACT ON THE PT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION S7 SYSTEM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. S7 NA

    Patients

    Seq Age Sex Outcome Treatment
    1