BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 1970921 · Received January 5, 2011

    Report

    Report Number
    1723170-2011-00016
    Event Type
    Malfunction
    Date Received
    January 5, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 2010
    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

    NO PT WAS INVOLVED WITH THIS CONCERN. THE RETURNED PRODUCT WAS EVALUATED AND FOUND TO BE OUT OF CALIBRATION. THE DEVICE MALFUNCTION WAS CONFIRMED AND DIRECTLY RELATED TO THE REPORTED EVENT. THE DEVICE WAS REPLACED AND THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THAT A CAMERA WAS OUT OF CALIBRATION. THERE WAS NO PT PRESENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1