BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2050133 · Received April 1, 2011

    Report

    Report Number
    1723170-2011-00577
    Event Type
    Malfunction
    Date Received
    April 1, 2011
    Date of Event
    September 24, 2010
    Report Date
    September 24, 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 PRESENT. SOFTWARE ERROR LOGS HAVE BEEN SENT IN FOR ANALYSIS, BUT THE SOFTWARE INVESTIGATION IS STILL IN PROGRESS.

    Description of Event or Problem · 1

    MEDTRONIC REPRESENTATIVE REPORTED THAT THE SYSTEM IS RUNNING SLOW IN THE SYNERGY CRANIAL APPLICATION. THIS EVENT DID NOT OCCUR DURING SURGERY AND NO PT WAS 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