Brief Statement:

Model 2020A CardioSight™ Reader

Intended Use: The Model 2020A CardioSight Reader is intended for use in a clinical setting. The CardioSight Reader is indicated for use to interrogate compatible Medtronic implantable devices to collect patient and device data and send the information to the clinician. The Model 2020A CardioSight Reader cannot be used to change therapy. Contraindications: There are no contraindications for the Model 2020A CardioSight Reader. Warnings and Precautions: The CardioSight Reader must only be used for interrogating compatible Medtronic implantable devices. Do not use a cellular phone while the antenna is positioned over the implanted device. The CardioSight Reader is designed for use in the continental United States, Alaska, and Hawaii.

Medtronic CRT-ICD Systems

Indications: Medtronic Cardiac Resynchronization Therapy (CRT) Implantable Cardioverter-Defibrillators (ICDs) are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias and 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 less than or equal to 35% and a prolonged QRS duration. Contraindications: CRT ICDs are contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes; patients with incessant VT or VF; patients who have a unipolar pacemaker. 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.

Medtronic ICDs

Indications: Medtronic implantable cardioverter defibrillators (ICDs) are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. Contraindications: Medtronic ICDs are contraindicated in patients whose ventricular tachyarrhythmias may have transient or reversible causes, patients with incessant VT or VF, patients who have a unipolar pacemaker, and patients whose primary disorder is bradyarrhythmia. Warnings/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. 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 appropriate technical manuals for detailed information regarding instructions for use, indications, contraindications, warnings and precautions, and potential 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 these devices to sale by or on the order of a physician.

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