Pulse generator - India CDSCO Medical Device Registration

Product Information

Implantation of a single-chamber pulse generator, dual-chamber pulse generator, or CRT-P (Optisure) is indicated in one or more of the following permanent conditions or any combinations of these symptoms: • Syncope • Presyncope • Fatigue • Disorientation due to arrhythmia or bradycardia. Implantation of a CRT-P is indicated for patients who: • Would benefit from resynchronization of the right and left ventricles. • Have one or more conventional indications for the implantation of a pacemaker. MR Conditional pulse generator is conditionally safe for use in the MRI environment when used in a complete MR Conditional pacing system and according to the instructions in the MRI-Ready System manual for the St. Jude Medical MR Conditional Pacing System. Rate-modulated pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity. Dual-chamber pacing (Optisure) is indicated for those patients exhibiting: • Sick sinus syndrome • Chronic, symptomatic second- and third-degree AV block • Recurrent Adams-Stokes syndrome • Symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out. Atrial pacing is indicated for patients with sinus node dysfunction and normal AV and intraventricular conduction systems. Ventricular pacing is indicated for patients with significant bradycardia and: • Normal sinus rhythm with only rare episodes of AV block or sinus arrest • Chronic atrial fibrillation (Optisure) • Severe physical disability. AF Suppression pacing (Optisure) is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications. AT/AF Detection Algorithm. The AT/AF detection algorithm is indicated for detecting atrial tachyarrhythmias which have been found to be associated with an increased risk of stroke in elderly, hypertensive, pacemaker patients without prior history of AF. For specific indications associated with individual modes, refer to the programmer’s on-screen help