BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION® I7¿ INTEGRATED NAVIGATION SYSTEM

    MDR report key: 2832381 · Received November 14, 2012

    Report

    Report Number
    1723170-2012-00629
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 16, 2012
    Report Date
    October 16, 2012
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, NO FILES HAVE BEEN RECEIVED BY THE MANUFACTURER FOR SOFTWARE EVALUATION.

    Description of Event or Problem · 1

    A SITE NEURO COORDINATOR REPORTED THAT WHILE IN A SPINE CASE, THEY HAD TAKEN TWO O-ARM SPINS, WENT BACK IN THE SOFTWARE TO PULL UP THE OTHER SCAN (THEY HAD TAKEN TWO SCANS BECAUSE PROCEDURE WAS TEN LEVELS) AND WHEN THE SCAN WAS SELECTED, THE SOFTWARE SUDDENLY EXITED AND REMAINED ON THE MEDTRONIC SCREEN. THE I7 WAS POWERED DOWN, THEN RE-STARTED PROPERLY. THE SURGEON COMPLETED THE PROCEDURE WITH THE USE OF NAVIGATION. NO IMPACT TO THE PATIENT OUTCOME WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION® I7¿ INTEGRATED NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. I7

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR