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Protecta XT TM

CRT-D and DR ICDs with SmartShock Technology TM

With Protecta, 98% of ICD patients are free of inappropriate shocks at 1 year and 92% at 5 years.*1

Brief Statement: Protecta™ CRT-D/DR ICDs Indications Protecta/Protecta XT implantable cardioverter defibrillators (ICDs) and CRT-D ICDs are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. Protecta/Protecta XT (CRT-D) ICDs are also indicated 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. Atrial rhythm management features 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 an ICD indication. Additional Protecta/Protecta XT System Notes: The use of the device has not been demonstrated to decrease the morbidity related to atrial tachyarrhythmias. • The effectiveness of high-frequency burst pacing (atrial 50 Hz Burst therapy) in terminating device classified atrial tachycardia (AT) was found to be 17%, and in terminating device classified atrial fibrillation (AF) was found to be 16.8%, in the VT/AT patient population studied. • The effectiveness of high-frequency burst pacing (atrial 50 Hz Burst therapy) in terminating device classified atrial tachycardia (AT) was found to be 11.7%, and in terminating device classified atrial fibrillation (AF) was found to 18.2% in the AF-only patient population studied.

Additional Protecta XT DR System Notes: The ICD features of the device function the same as other approved Medtronic marketreleased ICDs. • Due to the addition of the OptiVol® diagnostic feature, the device indications are limited to the NYHA Functional Class II/III heart failure patients who are indicated for an ICD. • The clinical value of the OptiVol fluid monitoring diagnostic feature has not been assessed in those patients who do not have fluid retention related symptoms due to heart failure. Contraindications Protecta/Protecta XT CRT-ICDs are 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 devices are also contraindicated for patients who have a unipolar pacemaker implanted, patients with incessant VT or VF, or patients whose primary disorder is chronic atrial tachyarrhythmia with no concomitant VT or VF. Warnings and Precautions ICDs: 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. Additionally, for CRT-ICDs, certain programming and device operations may not provide cardiac resynchronization.

www.medtronic.com * Primary prevention patient programmed for detection rate cut off at 188 bpm.

Potential Complications Potential complications include, but are not limited to, acceleration of ventricular tachycardia, air embolism, bleeding, body rejection phenomena which includes local tissue reaction, cardiac dissection, cardiac perforation, cardiac tamponade, chronic nerve damage, constrictive pericarditis, death, device migration, endocarditis, erosion, excessive fibrotic tissue growth, extrusion, fibrillation or other arrhythmias, fluid accumulation, formation of hematomas/seromas or cysts, heart block, heart wall or vein wall rupture, hemothorax, infection, keloid formation, lead abrasion and discontinuity, lead migration/dislodgement, mortality due to inability to deliver therapy, muscle and/or nerve stimulation, myocardial damage, myocardial irritability, myopotential sensing, pericardial effusion, pericardial rub, pneumothorax, poor connection of the lead to the device, which may lead to oversensing, undersensing, or a loss of therapy, threshold elevation, thrombosis, thrombotic embolism, tissue necrosis, valve damage (particularly in fragile hearts), venous occlusion, venous perforation, lead insulation failure or conductor or electrode fracture. 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.

Changes in a patient’s disease and/or medications may alter the efficacy of a device’s programmed parameters or related features.

UC201204700 EN © Medtronic, Inc. 2012. Minneapolis, MN. All Rights Reserved. Printed in USA. 02/2012

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