BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 3053640 · Received April 11, 2013

    Report

    Report Number
    1723170-2013-00276
    Event Type
    Malfunction
    Date Received
    April 11, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 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

    INVESTIGATION INVOLVED ONSITE SIMULATED USE TESTING OF THE SYSTEM BY MEDTRONIC FIELD REPRESENTATIVE. PER SYSTEM CHECKOUT RESULTS THE SYSTEM FUNCTIONED PROPERLY DURING TESTING. UNABLE TO REPLICATE ISSUE.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION HAS BEEN REQUESTED, BUT NOT PROVIDED. NO PARTS OR FILES HAVE BEEN RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE CAMERA STOPPED WORKING HALF WAY THROUGH A NAVIGATED SPINE CASE UTILIZING THE STEALTHSTATION S7 NAVIGATION SYSTEM AND O-ARM IMAGING SYSTEM. THEY HAD TAKEN ONE NAVIGATED SPIN WITH THE O-ARM AND NAVIGATED HALF THE SPINE. THEY MOVED THE FRAME TO A NEW LOCATION AND ATTEMPTED TO DO A SECOND NAVIGATED SPIN. AT THIS POINT IN TIME THEY WERE UNABLE TO PICK UP THE O-ARM TRACKER OR SPINE FRAME WITH THE CAMERA. THEY STATED THE CAMERA HAD A CLEAR LINE OF SIGHT AND WAS AT A NORMAL DISTANCE AWAY. AT THIS POINT THEY DISCONTINUED NAVIGATION AND FINISHED THE REST OF THE CASE WITH 2D-FLUOROSCOPY. THEY DID A POST-OPERATIVE SPIN WITH THE O-ARM AND ALL HARDWARE WAS PLACED ACCURATE. THERE WAS NO NEGATIVE IMPACT TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156033 STEALTHSTATION S7 SYSTEM NEUROLOGICAL STEREOTAXIC INSTRUMENT HAW MEDTRONIC NAVIGATION, INC. S7

    Patients

    Seq Age Sex Outcome Treatment
    1 O-ARM 1000 IMAGING SYSTEM