Indications, Safety, and Warnings
Indications: The Maximo II CRT-D system is indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The system is also indicated for the 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 and have a left ventricular ejection fraction ≤ 35% and a prolonged QRS duration.
Contraindications: The Maximo II CRT-D system is contraindicated for patients experiencing tachyarrhythmias with transient or reversible causes including, but not limited to, the following: acute myocardial infarction, drug intoxication, drowning, electric shock, electrolyte imbalance, hypoxia, or sepsis. The device is contraindicated for patients who have a unipolar pacemaker implanted. The device is contraindicated for patients with incessant VT or VF.
Warnings and Precautions: Changes in a patient's disease and/or medications may alter the efficacy of the device's programmed parameters. Patients should avoid sources of magnetic and electromagnetic radiation to avoid possible underdetection, inappropriate sensing and/or therapy delivery, tissue damage, induction of an arrhythmia, device electrical reset, or device damage. Do not place transthoracic defibrillation paddles directly over the device. Certain programming and device operations may not provide cardiac resynchronization.
Potential Complications: Potential complications include, but are not limited to, rejection phenomena, erosion through the skin, muscle or nerve stimulation, oversensing, failure to detect and/or terminate tachyarrhythmia episodes, acceleration of ventricular tachycardia, and surgical complications such as hematoma, infection, inflammation, and thrombosis.
See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1 (800) 328-2518 and/or consult Medtronic's website at www.medtronic.com.
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.