BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEUROCYBERNETIC PROSTHESIS

    MDR report key: 348328 · Received August 24, 2001

    Report

    Report Number
    1644487-2001-00477
    Event Type
    Other
    Date Received
    August 24, 2001
    Report Date
    August 17, 2001
    Manufacturer
    CYBERONICS, INC.
    Product Code
    LYJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    DUE TO ADVERSE EVENTS RECENTLY REPORTED BY ANOTHER MFR CONCERNING THE INTERACTION BETWEEN NEUROSTIMULATION DEVICES AND DIATHERMY THERAPY, CYBERONICS CONDUCTED IN VITRO TESTING THAT RESULTED IN CONTRAINDICATING THE USE OF DIATHERMY THERAPY FOR THOSE PTS IMPLANTED WITH THE CYBERONICS NCP SYSTEM. THERE HAVE BEEN NO KNOWN EVENTS INVOLVING CYBERONICS NCP PTS AND DIATHERMY THERAPY. DIATHERMY THERAPY, WHEN USED IN PTS IMPLANTED WITH THE NCP SYSTEM, CAN CAUSE HEATING OF EITHER OR BOTH THE NCP GENERATOR OR NCP LEAD, AND CAN POTENTIALLY DAMAGE THE GENERATOR OR LEAD. THE HEATING OF THE NCP SYSTEM FROM DIATHERMY THERAPY MAY CAUSE TEMPORARY OR PERMANENT NERVE, TISSUE, OR VASCULAR DAMAGE, POTENTIALLY LEADING TO A SERIOUS INJURY, INCLUDING A POSSIBILITY OF DEATH, IN THE EVENT OF VASCULAR DAMAGE. BY MEANS OF A SAFETY ALERT, ALL PHYSICIANS, HOSPITAL ADMINISTRATORS, AND PTS OF RECORD USING THE NCP SYSTEM WILL BE NOTIFIED ABOUT THIS ISSUE. DISTRIBUTION OF THE SAFETY ALERT IS SCHEDULED TO BEGIN ON AUGUST 27, 2001.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38621 NEUROCYBERNETIC PROSTHESIS BIPOLAR LEAD LYJ CYBERONICS, INC. 300 ALL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA MODEL 100 OR MODEL 101 GENERATOR.