Disclosure

Intended use

Vitatron implantable pulse generator systems are indicated to improve cardiac output, prevent symptoms, or protect against arrhythmias related to cardiac impulse formation of conduction disorders. The rate responsive modes may be beneficial in patients with exercise intolerance or limitations caused by chronotropic incompetence.

Contraindications

There are no known contraindications for the use of pacing as a therapeutic modality to control heart rate. The patient's age and medical condition, however, may dictate the particular pacing system, mode of operation, and implantation procedure used by the physician. Rate responsive modes may be contraindicated in those patients who cannot tolerate pacing rates above the programmed Lower Rate.

Warnings/precautions

Side effects

Possible side effects include, but are not limited to; body rejection phenomena including local tissue reaction, muscle and nerve stimulation, infection, erosion of pacemaker/lead through the skin, transvenous lead-related thrombosis, embolism and cardiac tamponade.

See the appropriate technical manual for specific pacing mode indications and contraindications, detailed warnings and precautions, and potential complications. See the warranty cards for information regarding warranties.

CAUTION: Federal Law (U.S.A.) restricts this device to sale by or on the order of a physician.