CAUTION: FEDERAL LAW (USA) RESTRICTS THIS DEVICE TO SALE, DISTRIBUTION AND USE BY OR ON THE ORDER OF A PHYSICIAN.
Brief Summary: Prior to using these devices, please review the User’s Manual for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
Indications: The pulse generators are indicated for: Accepted Patient Conditions warranting chronic cardiac pacing, which include: 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 in patients with sinus node dysfunction and normal AV and intraventricular conduction systems. Ventricular Pacing in patients with significant bradycardia and: normal sinus rhythm with only rare episodes of A-V block or sinus arrest requiring short periods of pacing support, chronic atrial fibrillation, severe physical disability. Rate-Modulated Pacing in patients who would benefit from increased pacing rates concurrent with physical activity.
Contraindications: The pulse generators are contraindicated for: single-Chamber Ventricular Demand Pacing in patients who have demonstrated pacemaker syndrome, have retrograde VA conduction, or who suffer a drop in arterial blood pressure with the onset of ventricular pacing, single-Chamber Atrial Pacing in patients who have demonstrated compromise of AV conduction, rate-Modulated Pacing in patients who experience angina or other symptoms of myocardial dysfunction at higher sensor-driven rates, unipolar pacing in patients with an implanted cardioverter-defibrillator (ICD) since it may inhibit or trigger ICD therapy. The pulse generators are programmed to unipolar pacing and may be inappropriate for patients with an ICD.
Potential Adverse Events: Adverse events associated with the use of any pacing system include: air embolism, bleeding/hematoma, body rejection phenomena, cardiac tamponade or perforation, formation of fibrotic tissue, local tissue reaction, Inability to interrogate or program due to programmer or device malfunction, infection/erosion, interruption of desired pulse generator function due to electrical interference, either electromyogenic or electromagnetic, lead malfunction due to conductor fracture or insulation degradation, loss of capture or sensing due to lead dislodgment or reaction at the electrode/ tissue interface, loss of desired pacing and/or sensing due to lead displacement, body reaction at electrode interface or lead malfunction (fracture or damage to insulation), loss of normal device function due to battery failure or component malfunction, pacemaker migration, pocket erosion or hematoma, pectoral muscle or diaphragmatic stimulation, phrenic nerve stimulation, pneumothorax/hemothorax.
Refer to the User’s Manual for detailed indications, contraindications, warnings, precautions and potential adverse events.