BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2985615 · Received March 1, 2013

    Report

    Report Number
    1723170-2013-00146
    Event Type
    Malfunction
    Date Received
    March 1, 2013
    Date of Event
    March 8, 2013
    Report Date
    March 8, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT SYSTEM CONTROL UNIT (SCU) WAS RECEIVED BY MANUFACTURER FOR EVALUATION. THE SCU POWERED UP NORMALLY, BUT THE EVENT LOG HAD RECORDED MANY INTERMITTENT INTERNAL STROBER ERRORS. REPLACING THE SCU ON THE NAVIGATION SYSTEM IN THE FIELD RESOLVED THE ISSUE.

    Additional Manufacturer Narrative · 1

    NO PATIENT INFORMATION PROVIDED AS NO PATIENT WAS INVOLVED IN THIS CONCERN. A FAULT WAS DISPLAYED IN THE SCU SOFTWARE INTERFACE. RMA ISSUED FOR REPLACEMENT SCU. SUSPECT DEVICE HAS NOT BEEN RETURNED TO MANUFACTURER FOR FURTHER EVALUATION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED A FAULT ON A STEALTHSTATION S7 SYSTEM CONTROL UNIT (SCU), CAUSING INTERMITTENT BEHAVIOR WITH THE FOOT PEDAL AND CAMERA COMMUNICATION. THERE WAS NO PATIENT PRESENT AT THE TIME OF THE ALLEGED MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90430 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1