BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STEALTHSTATION S7 SYSTEM

    MDR report key: 2884250 · Received December 21, 2012

    Report

    Report Number
    1723170-2012-00783
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    MEDTRONIC NAVIGATION, INC.
    Product Code
    HAW
    PMA / PMN Number
    K050438
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT SEX AND AGE PROVIDED. PATIENT WEIGHT AND ID WERE UNAVAILABLE.

    Additional Manufacturer Narrative · 1

    THE PATIENT DEMOGRAPHIC INFORMATION HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME. THE MEDTRONIC REP REPORTED THAT THE DRF WAS DISPOSED OF BY THE SITE AFTER THE CASE, SO IT CANNOT BE EVALUATED.

    Description of Event or Problem · 1

    A MEDTRONIC REPRESENTATIVE REPORTED THAT THE DYNAMIC REFERENCE FRAME (DRF) WAS INTERMITTENTLY TRACKING AFTER REGISTRATION DURING A TUMOR RESECTION UTILIZING SYNERGY CRANIAL AXIEM NAVIGATION. THEY WERE ABLE TO COMPLETE REGISTRATION WITHOUT ANY ISSUES TRACKING THE DRF. AFTER REGISTRATION WAS COMPLETED, COPPER LEADS WERE PLACED IN THE PATIENT FOR NERVE MONITORING. IN THE NAVIGATE PHASE OF THE SOFTWARE APPLICATION, THE DRF WAS INTERMITTENTLY TRACKED BY THE EMITTER. THEY TRIED RE-POSITIONING THE EMITTER, BUT THIS DID NOT RESOLVE ISSUE. THE AXIEM STYLET PROBE WAS TRACKING WITHOUT ISSUE. THE SURGEON WAS ABLE TO COMPLETE THE CASE WITH NAVIGATION. NO NEGATIVE IMPACT TO THE PATIENT WAS REPORTED.

    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 72 YR