BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 4221435 · Received November 3, 2014

    Report

    Report Number
    1723170-2014-01175
    Event Type
    Malfunction
    Date Received
    November 3, 2014
    Date of Event
    October 9, 2014
    Report Date
    October 9, 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

    A MEDTRONIC REPRESENTATIVE PERFORMED A NAVIGATION SYSTEM CHECK-OUT, ALL AREAS PASSED. SYSTEM PERFORMED AS INTENDED. NO PARTS HAVE BEEN RETURNED TO MANUFACTURER FOR ANALYSIS.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT, WHILE IN A CRANIAL PROCEDURE, THE SURGEON ALLEGED A SLIGHT INACCURACY AFTER GOING STERILE. THE SURGEON STATED THAT ACCURACY WAS GREAT IMMEDIATELY AFTER REGISTERING THE PATIENT WITH POINTMERGE. THE SURGEON COULD NOT PROVIDE A SPECIFIC MEASUREMENT OF THE ALLEGED INACCURACY, OR TELL IN WHAT DIRECTION IT WAS. THE SURGEON OPTED TO CONTINUE THE PROCEDURE, WITH THIS KNOWLEDGE, AND COMPLETED WITH THE USE OF THE NAVIGATION SYSTEM. THERE WAS NO DELAY IN THE SURGERY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701080 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR