Device Category Dossier

Single-chamber pacemaker, rate-responsive

Device Category Dossier for Single-chamber pacemaker, rate-responsive. Australian ARTG records, sponsors, device class — compiled by arcimedes.

Rate-responsive single-chamber implantable pacemakers are used in combination with atrial and/or right ventricular pacing leads to sense and record the electrical activity of the patient's heart and automatically respond to bradycardia by providing atrial and/or ventricular pacing through electrical impulses, with physiological sensors that adjust the pacing rate based on the patient's physical activity. These devices are indicated for symptomatic paroxysmal or permanent second- or third-degree atrioventricular block, symptomatic bilateral bundle branch block, symptomatic paroxysmal or transient sinus node dysfunctions with or without associated atrioventricular conduction disorders, bradycardia-tachycardia syndrome, and vasovagal or hypersensitive carotid sinus syndromes.