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6.2. Potential Adverse Events
Adverse events reported during clinical studies as statistically significant are
listed below in alphabetical order3:
♦ 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
♦ Worsening of cardiac abnormalities, including heart rate and rhythm

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