BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2040343 · Received February 15, 2011

    Report

    Report Number
    1723170-2011-00659
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 18, 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

    NO PT INFO PROVIDED AS NO PT WAS INVOLVED IN THIS CONCERN. THE SYSTEM WAS OBSERVED TO CYCLE REPEATEDLY. THE SCU, (SYSTEM CONTROL UNIT WAS REPLACED), AND FOUND TO BE FAULTY AFTER TESTING IN HOUSE. HOWEVER, THE SYSTEM IN THE FIELD STILL CYCLED. THEREFORE, THE SCU WAS REPLACED A SECOND TIME, BUT THE ISSUE PERSISTED. THE CAMERA WAS REPLACED AND AFTER IN HOUSE TESTING FOUND TO BE FAULTY. REPLACING BOTH SCU AND THE CAMERA RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED A SCU (SYSTEM CONTROL UNIT) NOT WORKING PROPERLY. THERE WAS NO PT PRESENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE