1. Real World Performance of Rhythm Discrimination Algorithms in Hard-to-Treat Single Chamber ICD Patients James Coles, PhD Medtronic, Inc.

2. 20% 65% SVT Is the Most Common Cause of an Inappropriate Shock SmartShock ® Technology Oversensing/Artifact T-Wave Discrimination Lead Integrity Alert Lead Noise Discrimination Supraventricular Tachycardia Wavelet + PR Logic ® SVT Discriminators in VF Zone Non-Sustained Ventricular Tachycardia Confirmation+ 20% 65% 1 Poole JE, et al. N Engl J Med. 2008;359:1009-1017.

3. Historically, Medtronic has Demonstrated Fewer Inappropriate Detections in Single Chamber ICDs Objective: Compare time to first inappropriate therapy after minimum 1-year follow-up Randomization Medtronic: Maximo, Marquis, Intrinsic, Virtuoso or Entrust Guidant : VITALITY 2 In single chamber ICDs: 63% higher risk of inappropriate shock with Guidant relative to Medtronic 1 Gold MR, et al. Heart Rhythm. 2012;9:370-377.

4. The START study confirmed the findings of RIGHT Objective: Compare the sensitivity and specificity of discrimination for ventricular arrhythmias. 50 atrial episodes bench tested: –Boston Scientific (Teligen) –St. Jude Medical (Atlas II+) –Medtronic (Secura and Virtuoso) –Cameron Health S-ICD In single chamber ICDs : 86% lower inappropriate detections relative to St. Jude Medical 73% lower inappropriate detections relative to Boston Scientific 2 Gold MR, et al. J Cardiovasc Electrophysiol. 2012;23:359-366.

5. MADIT II: History of Atrial Fibrillation Increases the Risk of Inappropriate Shocks Baseline VariableHazard Ratio 95% Confidence Interval p Value Atrial Fibrillation2.901.65-5.09<0.01 Smoking2.181.09-4.35 0.03 Diastolic BP ≥ 80 mmHg 1.611.03-2.52 0.04 3-fold increased risk of an inappropriate shock with baseline history of AF Daubert JP, et al. J Am Coll Cardiol. 2008;51:1357-1365.

6. Meta-Analysis: Inappropriate Therapies for AT Are More Common in Single Chamber ICDs In randomized trials, dual chamber ICDs are 36% less likely to deliver an inappropriate therapy for atrial tachyarrhythmias relative to single chamber ICDs. Theuns DA, et al. Int J Cardiol. 2008;125:352–357.

7. The PainFREE SST Study Population Resembles a “Real World” ICD Patient Population PF SST 1 National Cardiovascular Data Registry (NCDR) 2 MADIT-RIT 3 High-Rate Single Chamber (%) Dual Chamber (%) Triple Chamber (%) 27% 34% 39% 18% 36% 42% 0% 50% Primary Prevention (%) Secondary Prevention (%) 69% 31% 77% 23% 100% 0% De Novo Implant (%) Generator Change (%) 67% 33% 57% 40% 100% 0% Hx of AF, any (%)30%36%11% 1 Auricchio, et al. Heart Rhythm. 2015 in press. 2 Kremers MS, et al. Heart Rhythm. 2013;10:e59-e65. 3 Moss AJ, et al. N Engl J Med. 2012;367:2275-2283.

8. The PainFree SST Clinical Study Showed Low Rates of Inappropriate Shocks across All ICDs Dual Chamber and CRT ICDs: 98.5% Inappropriate Shock Free at 1 Year Single Chamber ICDs: 97.5% Inappropriate Shock Free at 1Year Auricchio, et al. Heart Rhythm. 2015 in press.

9. Summary Atrial Tachyarrhythmias are associated with an increased risk of inappropriate shocks, particularly in Single Chamber ICDs The PainFREE SST study included patients excluded from other shock reduction trials, including those with a history of Atrial Tachyarrhythmias and Single Chamber ICDs Historically, Medtronic has Demonstrated Fewer Inappropriate Detections in Single Chamber ICDs In the PainFREE SST study, 97.5% of Single Chamber ICD recipients were inappropriate shock free at 1 year

10. Indications Implantable cardioverter defibrillators (ICDs) are indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. Some ICDs are also indicated for use in patients with atrial tachyarrhythmias, or those patients who are at significant risk for developing atrial tachyarrhythmias. The RV Lead Integrity Alert (LIA) feature is intended primarily for patients who have a Medtronic ICD or CRT-D device and a Sprint Fidelis lead (Models 6949, 6948, 6931, and 6930, based on performance data. The RV LIA feature may not perform as well with a St. Jude Riata/Durata lead or a Boston Scientific Endotak lead as it does when used with a Medtronic Sprint Fidelis lead. This is because different lead designs may have different failure signatures and conditions that may or may not be detected early by the RV LIA feature. Notes for ICDs: The ICD features of the device functions the same as other approved Medtronic market-released 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. Additional notes for DR ICDs: 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 be 18.2% in the AF-only patient population studied. Contraindications ICDs are contraindicated in 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; patients who have a unipolar pacemaker implanted, patients with incessant ventricular tachycardia (VT) or ventricular fibrillation (VF), and patients whose primary disorder is chronic atrial tachyarrhythmia with no concomitant VT or VF. Brief Statement: ICDs Last Updated: Oct 2014

11. 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 arrhythmia episodes, and surgical complications such as hematoma, infection, inflammation, and thrombosis. An additional complication for ICDs is the acceleration of ventricular tachycardia. 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.www.medtronic.com Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. Brief Statement: ICDs Last Updated: Oct 2014