Device Dossier

Dual Chamber Temporary External Pacemaker, Model 5392 - Pacemaker, cardiac, external, invasive

Device Dossier for Dual Chamber Temporary External Pacemaker, Model 5392 - Pacemaker, cardiac, external, invasive (Pacemaker, cardiac, external,…

Intended purpose

The TEP is an external device intended for short-term use, typically in a hospital environment, to monitor and regulate the patient’s heart rate. The TEP is used for atrial and/or ventricular sensing and pacing in conjunction with a cardiac pacing lead system. The TEP senses intrinsic electrical activity through lead electrodes, analyzes heart rhythms based on programmed detection parameters, and delivers pacing pulses to treat bradyarrhythmias. A secondary function of the TEP is to provide high-rate burst pacing therapy indicated for atrial use only.

Functional description

The Medtronic Model 5392 temporary external pacemaker is a portable, battery-powered, dual chamber, temporary external pacemaker (TEP) designed primarily for temporary antibradycardia pacing therapy in asynchronous or demand (synchronous) modes. It also provides high-rate burst pacing therapy for atrial tachyarrhythmias.

TGA Public Summary