Device Dossier

ENO SR Pacemaker - Single-chamber pacemaker, rate-responsive - Single-chamber pacemaker, rate-responsive

Device Dossier for ENO SR Pacemaker - Single-chamber pacemaker, rate-responsive - Single-chamber pacemaker, rate-responsive (Single-chamber pacemaker,…

Intended purpose

ENO SR models are rate responsive single chamber implantable pacemakers used in combination with atrial and/or right ventricular pacing lead(s). The devices sense and record the electrical activity of the patient's heart using the sensing electrodes of the implanted lead(s) and analyze heart rhythm based on selectable sensing and detection parameters. The devices automatically respond to bradycardia by providing atrial and/or ventricular pacing through the delivery of electrical impulses. The pacemakers are equipped with physiological sensor(s) to respond to the patient’s changing metabolic demand by adjusting the pacing rate based on the patient’s physical activity. The devices are MR Conditional in the 1.5T & 3T MR environment.

Functional description

ENO SR Pacemaker is single-chamber rate responsive pacemaker. It is equipped with a physiological sensor (minute ventilation) and an accelerometer to allow adaptation of pacing to suit the patient's activity

TGA Public Summary