Prior to using these devices, please review the Instructions for Use for a complete listing indications, contraindications, warnings, precautions, potential adverse events and directions for use.
The devices are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. AF Suppression™ pacing is indicated for suppression of paroxysmal or persistent atrial fibrillation in patients with the above ICD indication and sinus node dysfunction. Cardiac Resynchronization Therapy Defibrillators (CRT‑Ds) are also intended: to provide a reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy (as defined in the clinical trials section included in the Merlin PCS on-screen help) and have a left ventricular ejection fraction less than or equal to 35% and a prolonged QRS duration; to maintain synchrony of the left and right ventricles in patients who have undergone an AV nodal ablation for chronic (permanent) atrial fibrillation and have NYHA Class II or III heart failure.
Contraindications for use of the pulse generator system include ventricular tachyarrhythmias resulting from transient or correctable factors such as drug toxicity, electrolyte imbalance, or acute myocardial infarction.
Possible adverse events (in alphabetical order) associated with the system include, but are not limited to, the following: Acceleration of arrhythmias (caused by device), Air embolism, Allergic reaction, Bleeding, Cardiac tamponade, Chronic nerve damage, Death, Erosion, Exacerbation of heart failure, Excessive fibrotic tissue growth, Extracardiac stimulation (phrenic nerve, diaphragm, chest wall), Extrusion, Fluid accumulation, Formation of hematomas or cysts, Inappropriate shocks, Infection, Keloid formation, Lead abrasion and discontinuity, Lead migration/dislodgment, Myocardial damage, Pneumothorax, Shunting current or insulating myocardium during defibrillation with internal or external paddles, Potential mortality due to inability to defibrillate or pace, Thromboemboli, Venous occlusion, Venous or cardiac perforation. Patients susceptible to frequent shocks despite antiarrhythmic medical management may develop psychological intolerance to an ICD or CRT-D system that may include the following: Dependency, Depression, Fear of premature battery depletion, Fear of shocking while conscious, Fear of losing shock capability, Imagined shocking (phantom shock).