BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FNC MICROTARGETING DRIVE SYSTEM

    MDR report key: 5875239 · Received August 15, 2016

    Report

    Report Number
    3002250546-2016-00002
    Event Type
    Malfunction
    Date Received
    August 15, 2016
    Date of Event
    June 23, 2016
    Report Date
    August 9, 2016
    Manufacturer
    FHC, INC,
    Product Code
    HAW
    PMA / PMN Number
    K021775
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    .

    Description of Event or Problem · 1

    AFTER OTHERWISE UNEVENTFUL MICRORECORDING AND STIMULATION DURING THE IMPLANTATION OF THE FINAL ELECTRODE (THROUGH THE CENTRAL PORT OF MICRODRIVE SYSTEM) UNEXPECTED SIGNIFICANT ANTERIOR DEVIATION OF THE GUIDING TUBE AND STYLET (AT LEAST 2 MM WELL ABOVE THE TARGET) WAS OBSERVED PRECLUDING SAFE AND CORRECT IMPLANTATION OF THE DEFINITIVE ELECTRODE. MULTIPLE ATTEMPTS TO CORRECT THE PROBLEM FAILED, CONE EXCHANGE, TUBING EXCHANGE AND THE SURGERY HAD TO BE TERMINATED PREMATURELY. ON THE EXAMINATION OF THE SYSTEM AFTER SURGERY THE MALALIGNMENT OF THE CENTRAL PORT CANNOT BE EXCLUDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    529321 FNC MICROTARGETING DRIVE SYSTEM STEREOTACTIC MICRODRIVE SYSTEM HAW FHC, INC, 66-ZD-MD-01

    Patients

    Seq Age Sex Outcome Treatment
    1