BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2883749 · Received December 21, 2012

    Report

    Report Number
    1723170-2012-00755
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 29, 2012
    Report Date
    November 30, 2012
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT AGE AND WEIGHT IS NOT AVAILABLE AT THE TIME OF THIS REPORT.A MEDTRONIC REP WENT TO THE SITE WHERE A SYSTEM CHECKOUT WAS PERFORMED. THE SYSTEM IS FUNCTIONING NORMALLY; NO FURTHER ISSUES WERE EXPERIENCED. THE ARCHIVE WAS RECEIVED BY THE MANUFACTURER AND THE EVALUATION IS IN PROGRESS. NO FURTHER ISSUES WERE REPORTED.

    Description of Event or Problem · 1

    A BIOMEDICAL ENGINEER REPORTED AN INACCURACY OF 2CM DURING A CRANIAL RESECTION. IT SEEMS AS THOUGH THE Z-AXIS (DEPTH) IS SPOT ON, BUT THE X/Y AXIS IS WAY OFF DESPITE A SUCCESSFUL REGISTRATION. THE SURGEON REALIZED HE WAS 2CM INACCURATE ONCE IN THE RESECTION. THE SURGEON CHOSE TO DISCONTINUE THE USE OF NAVIGATION AND IMAGING TO COMPLETE THE PROCEDURE WITH NO NEGATIVE IMPACT TO THE PATIENT OUTCOME.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1