MRIACCESSEvera MRI™ SureScan™

ICD Systems

2 3

CONTOURED.Greater patient comfort

with 30% reduction in skin pressure.1

LONG-LASTING.So patients can spend more time living, and less time receiving device replacements.

SMART.*The most advanced shock reduction suite, so patients receive fewer inappropriate shocks.2

* SmartShock™

The Evera MRI™ SureScan™ ICD system is MR Conditional and, as such, is designed to allow patients to be safely scanned by an MRI machine when used according to the specified MRI conditions for use. A complete SureScan ICD system, including the Evera MRI SureScan ICD and one or two SureScan ICD leads, is required for use in the MRI environment.

MRI ACCESS.Introducing Evera MRI™, featuring SureScan™ MRI Technology.

36% of ICD patients are likely to have an MRI ordered over 4 years3

ICD Patients are not receiving MRIs

Data from 2012 were used to project MRI utilization in the ICD patient cohort over 4 years; whereas the actual MRI utilization rate over 4 years was measured in the non-ICD cohort.

Non-ICD Patient Cohort4

N = 9,385ICD Patient Cohort3

N = 9,385

MRI 1.4%

MRI 36%

5

EXPANDINGACCESS

Stroke patients with an ICD are not getting optimal diagnostic imaging44% of non-ICD patients undergo an MRI within 3 days of stroke or TIA diagnostic vs. 1% of patients with a traditional ICD.3

80%

60%

40%

Perc

ent o

f Pat

ient

s

20%

0%MRI CT Ultrasound

100%

44%

1%

72%75%

72%69%

Back Pain22% of non-ICD patients undergo an MRI within 30 days of back pain diagnosis vs. 0.7% of patients with a traditional ICD.3

Joint Pain (Knees, ankles, elbows, shoulders & wrists)

17% of non-ICD patients undergo an MRI within 30 days of joint pain diagnosis vs. 0.1% of patients with a traditional ICD.3

Non-ICD Patients ICD Patients

80%

60%

40%

Perc

ent o

f Pat

ient

s

20%

0%MRI CT X-ray

100%

22%

0.7%

21%

32% 29%27%

80%

60%

40%

Perc

ent o

f Pat

ient

s

20%

0%MRI CT X-ray

100%

17%

0.1%

16% 19%

30%28%

WITH EVERA MRIPATIENTS HAVE ACCESS TO FULL BODY MRI SCANNING6

CT MRI

§ Better for bony tissue

§ Uses ionizing radiation (multiple CT scans means added risk to patient as x-ray dose is cumulative)

§ Contrast, if used, is iodine based and may cause allergic reactions

§ Superior for soft tissue

§ Uses magnetic energy and RF (no cumulative dose risk)

§ Contrast (if used) has low risk

Together, we can now provide ICD patients optimal imaging,according to ACR.*5

* American College of Radiology.4

350,000+SureScan Pacemaker and ICD Systems sold worldwide14

18+ YEARSof MRI research experience

Industry-exclusive modeling testing safety of over

2.3 MILLION SCANNING SCENARIOS10

6+ YEARSof SureScan Pacemaker market experience

OVER 3,700patients enrolled in SureScan Pacemaker and ICD PROSPECTIVE Clinical Studies 7-9,11,13

PROVEN EVIDENCE AND EXPERIENCE

1997 2015

PROVEN

SureScan Technologybacked by 5 prospective clinical trials and robust computer modeling

DEVELOPSureScan Pacing Lead and Industry Exclusive Modeling Capability

TESTSureScan Lead with 400,000 Modeling Scenarios

EnRhythm MRI™

Clinical Trial7

464 SureScan Patients

Advisa MRI™ Clinical Trial9

263 SureScan Patients

REFINEImprove Modeling with Accuracy and Speed

TEST 5076 Lead, 6935M Lead, 6947M Lead with 2.3 million Modeling Scenarios10

5076 MRI Trial11

SureScan Post-Approval Clinical Study8

Evera MRI™ Clinical Trial13

Sprint Quattro MRI™, 6947M and 6935M leads

Evera MRI Clinical Study12

§ Prospective, randomized study§ 275 patients at

42 centers globally§ No positioning

restrictions§ Demonstrated that

the system is safe and effective

Post-MRI Results12

§ No MRI-related complications§ No difference in ventricular

pacing capture thresholds or sensing amplitude between the MRI and control groups§ No impact on detection

and therapy delivery

6 7

8 9

BUILT FOR MRIWe specifically engineered the Evera MRI SureScan ICDs for the MRI environment, with enhancements that ensure patient safety during an MRI scan.10

We made hardware component changes to ensure high energy fields do not damage circuits and firmware changes, for ease of use.10

Leads: Now with MRI AccessCombine SureScan leads with a SureScan device in any combination.

Defibrillation Leads§ Designed for Reliability

§ Proven by Active Monitoring

With over 10 years of experience, the Sprint Quattro™ family of leads has proven performance you can depend on for your ICD patients. The 6947M and the 6935M are now approved for use in the MR environment.

Pacing LeadsThe 5076 and 5086 pacing leads have been tested and approved for use in the MR environment.

6935M 6947M

(55, 62 cm lengths)

5086 5076

PHYSIOCURVETM 30% reduction in skin pressure1

Tapered at the header and bottom of device to reduce skin pressure and promote patient comfort

Smaller footprint for a smaller incision

Designed with lead wrap in mind: Landing area to minimize additional stress on the lead15

SureScan Systems proven to mitigate the following hazards10:

P P unintended cardiac stimulation

P device interactions in the MRI

force, torque and heating

10 11

SMARTSHOCK™ 2.0 TECHNOLOGY

* Eligible devices: Viva™ XT, Viva S, Protecta™ XT, Protecta ICD CRT-Ds; Evera MRI™ XT, Evera MRI S, Evera™ XT, Evera S, Protecta XT, Protecta ICDs.** SmartShock Technology algorithms must be programmed “ON” (with parameter settings below) at the time of the inappropriate shock. Medtronic will cover

uninsured medical expenses, not to exceed $500, per patient shocked event. This offer is valid for the lifetime of the device.

98.5% of dual chamber and triple chamber patients and 97.5% of single chamber patients were free from inappropriate shocks at one year.2

97.5%Single Chamber

98.5%Dual and Triple Chamber

INDUSTRY-LEADING PROJECTED LONGEVITY AND WARRANTY

Months since implant

Inappropriate shock rates for Single, Dual and Triple Chamber ICD patients

No. at Risk

713 641 590 362 1351,885 1,687 1,532 1,121 679

2.5%

1.5%Inci

denc

e o

f Ina

ppro

pria

te S

hock

(%)

00 6 12 18 24

2

4

6

8

10

12

Dual and Triple Chamber

Single Chamber

UNMATCHED ASSURANCE Our performance assurance program demonstrates the confidence we have in SmartShock.

We will reimburse up to $500 to any patient with an eligible device* — one with SmartShock or SmartShock 2.0 Technology — who receives an inappropriate shock, to help cover certain unreimbursed medical expenses incurred while seeking medical care.**

9.7 YEARSProjected Longevity Dual Chamber Evera MRI XT and Evera MRI S

11 YEARSProjected Longevity Single Chamber Evera MRI XT

Projected Service Life (longevity) is based on VVI for VR and DDD for DR devices with 0% pacing from the manuals of the Evera MRI models listed.16 The Evera MRI S and XT models share the same battery, telemetry and programming features that impact longevity.

* Limited lifetime warranty, some restrictions may apply. The limited lifetime warranty applies to the performance of the device and includes some reimbursement to patients of unreimbursed medical expenses. The warranty is limited to the provisions in the written Limited Warranty document that accompanies each product. Consult the written limited warranty document for details, a copy of which will be provided upon request.

Evera MRI ICD Projected Longevity

8 YEARSWarranty for Evera MRI XT DR*

10 YEARSWarranty for Evera MRI XT VR*

Industry-Leading Warranties for Evera MRI XT

Out-of-the-box settingsSmartShock is nominally on and clinically proven to reduce shocks

References 1 Flo, Daniel. Device Shape Analysis. January 2013. Medtronic data on file. 2 Auricchio A, Schloss EJ, Kurita T, et al. Low inappropriate shock rates in patients

with single- and dual/triple-chamber implantable cardioverter-defibrillators using a novel suite of detection algorithms: PainFree SST trial primary results. Heart Rhythm. May 2015;12(5):926-936.

3 Nazarian S, Reynolds MR, Ryan MP, Wolff SD, Mollenkopf SA, Turakhia MP. Utilization and likelihood of radiologic diagnostic imaging in patients with implantable cardiac defibrillators. J Magn Reson Imaging. Published online J une 27, 2015.

4 Medtronic data on file 2015: Data from MarketScan® 2012 Commercial and Medicare Database, Truven Health Analytics.

5 American College of Radiology, ACR Appropriateness Criteria®. Available at www.acr.org/ac. Accessed June 29, 2015.

6 http://www.diffen.com/difference/CT_Scan_vs_MRI. 7 Wilkoff BL, Bello D, Taborsky M, et al. Magnetic resonance imaging in patients with

a pacemaker system designed for the magnetic resonance environment. Heart Rhythm. January 2011;8(1):65-73.

8 Ramza B, et al. Are There Cumulative Effects of Multiple MRI on MR-conditional Pacemakers? Presented at HRS, May 2014.

9 Gimbel JR, Bello D, Schmitt M, et al. Randomized trial of pacemaker and lead system for safe scanning at 1.5 Tesla. Heart Rhythm. May 2013;10(5):685-691.

10 Gold MR, Kanal E, Schwitter J, et al. Preclinical evaluation of implantable cardioverter-defibrillator developed for magnetic resonance imaging use. Heart Rhythm. March 2015;12(3):631-638.

11 Evaluation of Approved Pacing Lead (Model 5076) for Use in MRI Environment, clinicaltrials.gov, NCT01755143.

12 Gold MR, Sommer T, Schwitter J, et al. Full-Body MRI in Patients With an Implantable Cardioverter-Defibrillator: Primary Results of a Randomized Study. J Am Coll Cardiol. June 23, 2015;65(24):2581-2588.

13 Confirmatory Clinical Trial of the Evera MRI System for Conditionally-Safe MRI Access, clinicaltrials.gov, NCT02117414.

14 Poor, Corinne. MRI™ SureScan™ Units Sold from FY09 – FY15. June 2015. Medtronic Data on File.

15 Lulic, Tom. Medtronic data on file. March 26, 2013. 16 http://manuals.medtronic.com/manuals/mri/region.

Brief Statement for Evera MRI™ System

The Evera MRI SureScan™ defibrillation system is MR Conditional and, as such, is designed to allow patients to be safely scanned by an MRI machine when used according to the specified MRI conditions for use. When programmed to On, the MRI SureScan feature allows the patient to be safely scanned while the device continues to provide appropriate pacing.

Indications for Use The Evera MRI SureScan system is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. In addition, the dual chamber devices are indicated for use in the above patients with atrial tachyarrhythmias, or those patients who are at significant risk of developing atrial tachyarrhythmias.

Notes:

§ The ICD features of the device function the same as other approved Medtronic market-released ICDs. The following notes are applicable based on the features available in the specific Evera MRI model.

§ 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.

A complete SureScan defibrillation system is required for use in the MR environment, which is an Evera MRI SureScan ICD device with a SureScan defibrillation lead in the right ventricle and if using a dual chamber ICD, a SureScan atrial pacing lead. To verify that components are part of a SureScan system, visit http://www.mrisurescan.com. Any other combination may result in a hazard to the patient during an MRI scan.

Contraindications The Evera MRI SureScan 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. For dual chamber devices, the device is contraindicated for patients whose primary disorder is chronic atrial tachyarrhythmia with no concomitant VT or VF. For single chamber devices, the device is contraindicated for patients whose primary disorder is atrial tachyarrhythmia.

Warnings and Precautions Changes in 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.

Patients and their implanted systems must be screened to meet the following requirements for MRI: no implanted lead extenders, lead adaptors or abandoned leads; no broken leads or leads with intermittent electrical contact as confirmed by lead impedance history; a SureScan defibrillation system implanted in the left or right pectoral region; pacing capture thresholds of ≤ 2.0 V at a pulse width of 0.4 ms; no diaphragmatic stimulation at a pacing output of 5.0 V and at a pulse width of 1.0 ms in patients whose device will be programmed to an asynchronous pacing mode when MRI SureScan is programmed to On.

Patients may be scanned using a horizontal field, cylindrical bore, clinical 1.5T MRI system with operating frequency of 64 MHz, maximum spatial gradient ≤ 20 T/m, and maximum gradient slew rate performance per axis ≤ 200 T/m/s. Scanner must be operated in Normal Operating Mode (whole body averaged specific absorption rate (SAR) ≤ 2.0 W/kg, head SAR ≤ 3.2 W/kg).

Continuous patient monitoring is required while MRI SureScan is programmed to On. While MRI SureScan is programmed to On, arrhythmia detection and therapies are suspended, leaving the patient at risk of death from untreated spontaneous tachyarrhythmia. In addition, if the device is programmed to an asynchronous pacing mode, arrhythmia risk may be increased.

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. Other potential complications related to the lead may include lead dislodgement, lead conductor fracture, insulation failure, threshold elevation or exit block.

The SureScan system has been designed to minimize potential complications in the MRI environment. Potential MRI complications include, but are not limited to, lead electrode heating and tissue damage resulting in loss of sensing or capture or both, or MR-induced stimulation on leads resulting in continuous capture, VT/VF and/or hemodynamic collapse.

See the MRI SureScan Technical Manual before performing an MRI Scan and 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 or www.mrisurescan.com.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

medtronic.com

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Toll-free: 1 (800) 328-2518(24-hour technical support for physicians and medical professionals)