. Ataxia (muscle movements or twitching, generally associated with stimulation)

. Dyspepsia (indigestion)

. Dyspnea (difficulty breathing, shortness of breath)

. Hypesthesia (impaired sense of touch)

. Increased coughing

. Infection

. Insomnia (inability to sleep)

. Laryngismus (throat, larynx spasms)

. Nausea

. Pain

. Paresthesia (prickling of the skin)

. Pharyngitis (inflammation of the pharynx, throat)

. Voice alteration (hoarseness)

. Vomiting

Other potential adverse events possibly associated with surgery or stimulation include, but are not limited to, the following:

. Aspiration (fluid in the lungs)

. Blood clotting

. Choking sensation

. Damage to nerves or vasculature in the surgical area, including the carotid artery and jugular vein

. Device (Generator and/or Lead) migration or extrusion

. Dizziness

. Dysphagia (difficulty swallowing)

. Duodenal ulcer, gastric ulcer

. Ear pain

. Facial flushing

. Facial paralysis, paresis

. Foreign body reaction to implants, including possible tumor formation

. Formation of fibrous tissue, pockets of fluid

. Heart rate and rhythm changes

. Hiccuping

. Incision site pain

. Irritability

. Laryngeal irritation (sore, painful throat)

. Left hemidiaphragm paralysis

. Left recurrent laryngeal nerve injury

. Left vocal cord paralysis

. Low-grade fever

. Muscle pain

. Neck pain

. Nerve injury

. Painful or irregular stimulation

. Skin, tissue reaction

. Stomach discomfort

. Tinnitus (ringing in the ears)

. Tooth pain

. Unusual scarring at the incision site

. Urinary retention

. Vagus nerve paralysis

. Weight change

. Worsening of asthma and bronchitis

! Patients who manipulate the Pulse Generator and Lead through the skin may damage or disconnect the Lead from the Pulse Generator and/or possibly cause damage to the vagus nerve.

© Cyberonics, Inc. 2004