BEUDAMED
    FDA Adverse Event Other Summary report: N

    NEUROCYBERNETIC PROSTHESIS

    MDR report key: 348333 · Received August 24, 2001

    Report

    Report Number
    1644487-2001-00478
    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 MANUFACTURER 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 PATIENTS IMPLANTED WITH THE CYBERONICS NCP SYSTEM. THERE HAVE BEEN NO KNOWN EVENTS INVOLVING CYBERONICS NCP PATIENTS AND DIATHERMY THERAPY. DIATHERMY THERAPY, WHEN USED IN PATIENTS 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 PATIENTS 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
    38774 NEUROCYBERNETIC PROSTHESIS NEUROSTIMULATOR LYJ CYBERONICS, INC. 101 ALL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA MODEL 300 BIPOLAR LEAD.