BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION IOR SYSTEM

    MDR report key: 2440012 · Received January 19, 2012

    Report

    Report Number
    1723170-2012-00030
    Event Type
    Malfunction
    Date Received
    January 19, 2012
    Date of Event
    January 3, 2012
    Report Date
    January 3, 2012
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    RMAS ISSUED FOR TRANSCEIVERS AND CAMERA. HOWEVER, NOT ALL OF THE COMPONENTS HAVE BEEN RETURNED FOR EVALUATION. INVESTIGATION OF CAMERA FOUND THAT THE ISSUE WAS NOT ABLE TO BE DUPLICATED BY MEDTRONIC PERSONNEL. TRACKING AND ACCURACY WERE FOUND TO BE NORMAL THROUGHOUT THE VOLUME DURING FUNCTIONAL TESTING. A MEDTRONIC REP AT THE SITE FOUND THAT THE PCI CARD WAS LOOSE AT THE CPU. AFTER RE-SEATING THE CARD, THE SYSTEM WAS FULLY FUNCTIONAL. AFTER REPLACEMENT OF THE TRANSCEIVERS, THE SITE COMPLETED A SUCCESSFUL CASE WITHOUT ISSUE.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THE STEALTHSTATION IOR SYSTEM CAMERA SHOWED BLACK STATUS AFTER THEY POWERED THE INTER-OPERATIVE ROOM BACK UP AND FOLLOWING THE INTRA-OPERATIVE SCAN. THE USE OF NAVIGATION WAS DISCONTINUED TO COMPLETE THE SURGERY. THERE WAS NO IMPACT ON PATIENT OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEALTHSTATION IOR SYSTEM STEREOTAXIC INSTRUMENT (HAW) HAW MEDTRONIC NAVIGATION, INC. IOR NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR