Device Dossier

ACCOLADE MRI DR Pacemaker L331 - Dual-chamber pacemaker, rate-responsive

Device Dossier for ACCOLADE MRI DR Pacemaker L331 - Dual-chamber pacemaker, rate-responsive (Dual-chamber pacemaker, rate-responsive, Class III, sponsor…

Intended purpose

Boston Scientific pacemakers are indicated for treatment of the following conditions: • Symptomatic paroxysmal or permanent second- or third-degree AV block • Symptomatic bilateral bundle branch block • Symptomatic paroxysmal or transient sinus node dysfunction with or without associated AV conduction disorders (i.e., sinus bradycardia, sinus arrest, sinoatrial [SA] block) • Bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias • Neurovascular (vaso-vagal) syndromes or hypersensitive carotid sinus syndromes Adaptive-rate pacing is indicated for patients exhibiting chronotropic incompetence and who may benefit from increased pacing rates concurrent with increases in minute ventilation and/or level of physical activity. Dual-chamber and atrial tracking modes are also indicated for patients who may benefit from maintenance of AV synchrony. Dual chamber modes are specifically indicated for treatment of the following: • Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block • VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm • Low cardiac output or congestive heart failure secondary to bradycardia

Functional description

This pulse generator provides bradycardia pacing and adaptive rate pacing to detect and treat bradyarrhythmias. The pulse generator has independently programmable outputs and accepts one or more of the following leads, depending on the model: • One IS-1 unipolar or bipolar atrial lead • One IS-1 unipolar or bipolar right ventricular lead’ Device includes ZIP telemetry. Connector type RA: IS-1, RV: IS-1. Case is hermetically sealed titanium. Supplied with a torque wrench

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