BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEALTHSTATION

    MDR report key: 533096 · Received July 6, 2004

    Report

    Report Number
    1723170-2004-00006
    Event Type
    Injury
    Date Received
    July 6, 2004
    Date of Event
    June 18, 2004
    Report Date
    July 6, 2004
    Manufacturer
    MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES
    Product Code
    HAW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT 3 SURGERIES DUE TO ALLEGED STEALTHSTATION NAVIGATION INACCURACIES TO REMOVE A SINUS LESION. INVESTIGATION CONFIRMED THAT STEALTHSTATION PERFORMED AS INTENDED AND THAT THE EVENT WAS DUE ISSUES WITH A DEVICE FROM ANOTHER MFR STEALTHSTATION DID NOT MALFUNCTION OR CONTRIBUTE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION IGS SYSTEM HAW MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES 9680111 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 * Hospitalization