BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2081503 · Received April 19, 2011

    Report

    Report Number
    1723170-2011-00882
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    March 24, 2011
    Report Date
    March 24, 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

    DEVICE MANUFACTURE DATE NOT AVAILABLE AT TIME OF THIS REPORT. THE RETURNED PRODUCT DID NOT MEET SPECIFICATIONS. THE DEVICE MALFUNCTION WAS CONFIRMED AND DIRECTLY RELATED TO THE REPORTED EVENT. THE ILLUMINATOR CURRENT IS MOVING IN AND OUT OF RANGE. A REPLACEMENT PART WAS SENT TO THE SITE AND THE ISSUE WAS RESOLVED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT STEALTHSTATION S7 SYSTEM SPECTRA CAMERA HAS A FAULT. THE ILLUMINATOR CURRENT MEASURED LOWER THAN RECOMMENDED OPERATING CURRENT. THERE WAS NO PT PRESENT.

    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 NONE