BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION® I7¿ INTEGRATED NAVIGATION SYSTEM

    MDR report key: 2687438 · Received August 8, 2012

    Report

    Report Number
    1723170-2012-00415
    Event Type
    Malfunction
    Date Received
    August 8, 2012
    Date of Event
    July 24, 2012
    Report Date
    July 24, 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
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    NO PATIENT WAS PRESENT. THE LOG FILES WERE RETURNED AND FOUND TO BE INCONCLUSIVE. A MEDTRONIC REP CONFIRMED THAT THE USB CONFIGURATION WAS CORRECT WITH THE I7 SYSTEM AND WAS ABLE TO REPRODUCE THE REPORTED EVENT. AN RMA WAS ISSUED FOR THE TRANSCEIVER. THE TRANSCEIVER HAS BEEN RETURNED TO THE MANUFACTURER AND HAS NOT BEEN EVALUATED AS OF THE DATE OF THIS REPORT. A MEDTRONIC REP CONFIRMED THAT A REPLACEMENT TRANSCEIVER RESOLVED THE ISSUE AND THE SYSTEM WAS WORKING PROPERLY.

    Additional Manufacturer Narrative · 1

    THE I7 SYSTEM TRANSCEIVER WAS RECEIVED BY THE MANUFACTURER THEN CONNECTED THE TRANSCEIVER AND POWERED IT ON AND NO ISSUES WITH COMMUNICATION TO THE CAMERA WERE OBSERVED. CYCLED THE POWER SEVERAL TIMES AND EACH TIME IT ESTABLISHED COMMUNICATION WITH THE CAMERA. THE SYSTEM RAN FOR SEVERAL DAYS AND NO COMMUNICATION ISSUES WERE OBSERVED. REPEATED THE TESTING SEVERAL TIMES OVER A 2 WEEK PERIOD AND NO ISSUES WERE OBSERVED.

    Description of Event or Problem · 1

    A SITE REPRESENTATIVE REPORTED THAT THE CAMERA WAS NOT COMMUNICATING AND WAS DISPLAYED AS NOT CONNECTED WHEN THE I7 SYSTEM WAS INITIALLY TURNED ON. SHE RESET THE NIU AND THE CAMERA TEMPORARILY COMMUNICATED. A FEW MINUTES LATER, THE CAMERA COMMUNICATION WAS LOST AGAIN. RESETTING THE NIU DID NOT RESOLVE THE ISSUE. SHE REBOOTED THE I7 AND WAS ABLE TO ESTABLISH CAMERA COMMUNICATION AGAIN. THERE WAS NO PATIENT PRESENT.

    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