Brief Statement

Medtronic EnTrust Implantable Cardioverter Defibrillator (ICD) Models D154ATG and D154VRC

Indications

EnTrust Models D154ATG and D154VRC implantable cardioverter-defibrillator systems are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias.

In addition, EnTrust Model D154ATG system is intended to provide pacing, cardioversion, and defibrillation for treatment of patients with symptomatic, drug-refractory, atrial fibrillation. EnTrust Model D154ATG system is indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing atrial tachyarrhythmias. Atrial rhythm management features in EnTrust Model D154ATG system such as Atrial Rate Stabilization (ARS), Atrial Preference Pacing (APP), and Post Mode Switch Overdrive Pacing (PMOP) are indicated for the suppression of atrial tachyarrhythmias in ICD-indicated patients with atrial septal lead placement and one or more of the above ICD indications.

Contraindications

EnTrust Models D154ATG and D154VRC are contraindicated for patients experiencing any of the following conditions:

• Tachyarrhythmias with transient or reversible causes
• Incessant ventricular tachycardia or ventricular fibrillation
• Present implant of a unipolar implantable pulse generator
• Primary disorder of bradyarrhythmia

Additionally, EnTrust Model D154ATG is contraindicated for patients experiencing the following condition:

• Primary disorder of chronic atrial tachyarrhythmia with no concomitant VT or VF

Additionally, EnTrust Model D154VRC is contraindicated for patients experiencing the following condition:

• Primary disorder of atrial arrhythmia

Warnings/Precautions for EnTrust Models D154ATG and D154VRC

• 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.

Additional warning/precautions for EnTrust Models D154ATG

• Use of the device should not change the application of established anti-coagulation protocols. Following an ischemic or cerebrovascular accident, disable atrial cardioversion therapies until the patient has stabilized.

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 these devices to sale by or on the order of a physician.

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