BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2040358 · Received February 15, 2011

    Report

    Report Number
    1723170-2011-00658
    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
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    NO PT INFO PROVIDED AS NO PT WAS INVOLVED IN THIS CONCERN. THE BATTERY BACK UP POWER SUPPLY WAS REPLACED IN THE SYSTEM AND THIS RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    A MEDTRONIC REP REPORTED THAT THE STEALTHSTATION S7 SYSTEM WOULD NOT STAY POWERED ON. HE REPORTED THAT THE SYSTEM WOULD PERFORM AS IF IT WERE POWERING AND GET TO THE APPLICATION SCREEN, AND WAS ABLE TO LAUNCH THE APPLICATION AND THEN POWER OFF. 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