BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION® I7¿ INTEGRATED NAVIGATION SYSTEM

    MDR report key: 3033688 · Received April 3, 2013

    Report

    Report Number
    1723170-2013-00244
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Date of Event
    March 6, 2013
    Report Date
    March 6, 2013
    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

    DUE TO CHARACTER LIMITATION THE COMPLETE PATIENT ID NUMBER IS: (B)(6). AFTER FURTHER EVALUATION OF THE SYSTEM ONSITE A MEDTRONIC REPRESENTATIVE FOUND THAT THE REFERENCE FRAME BRACKET ON THE MICROSCOPE HAD BEEN BUMPED, RENDERING THE MICROSCOPE/NAVIGATION SYSTEM CALIBRATION INACCURATE. THE SCOPE WILL BE RECALIBRATED TO RESOLVE ISSUE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT DURING A CRANIAL SURGERY NAVIGATION WHILE USING THE MICROSCOPE WAS ALLEGEDLY 1 CM INACCURATE. NAVIGATION WITH THE PROBES WAS ACCURATE. THE SURGEON CHOSE TO CONTINUE USING THE MICROSCOPE, BUT WITHOUT NAVIGATING IT. NO NEGATIVE IMPACT TO THE PATIENT OUTCOME WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    135855 STEALTHSTATION® I7¿ INTEGRATED NAVIGATION SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. I7

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR