BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 4251394 · Received November 14, 2014

    Report

    Report Number
    1723170-2014-01222
    Event Type
    Malfunction
    Date Received
    November 14, 2014
    Date of Event
    October 24, 2014
    Report Date
    October 24, 2014
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    SOFTWARE EVALUATION CONFIRMED REGISTRATION MODEL WAS CLEAN AND SMOOTH. USE ERROR IS SUSPECTED. (B)(4) 2014 A MEDTRONIC REPRESENTATIVE PERFORMED A NAVIGATION SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A SKULL BASE PROCEDURE, AFTER A SUCCESSFUL REGISTRATION, THE SURGEON DRAPED THE PATIENT THEN ALLEGED AN INACCURACY WHEN NAVIGATING IN AND AROUND THE EAR CANAL. THERE WAS NO SPECIFIC MEASUREMENT PROVIDED. THE SURGEON DECLINED RECOMMENDATIONS TO TROUBLE-SHOOT, AND OPTED TO CONTINUE THE PROCEDURE TO COMPLETION WITHOUT THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736881 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR