NEW INTELLIGENCE INSIDE. TruRhythm™ Detection inside the Reveal LINQ™ Insertable Cardiac Monitoring System World’s Smallest ICM. Now Smarter.
Reveal™ ICM evolution Accuracy Work Flow
TRURHYTHM™ DETECTION INSIDE evolution of reveal™ ICMs Now smarter TruRhythm™ Detection NEW intelligence inside the Reveal LINQ™ ICM World’s smallest ICM Reveal LINQ™ ICM World’s first ILR Reveal™ ILR 1998 2014 2017 TruRhythm™ Detection Inside the Reveal LINQ™ ICM
TRURHYTHM™ Detection inside Accuracy evolution NEW algorithms with Smart filtering Self-learning intelligence Streamlined episode review for clinic efficiency1,2 TruRhythm™ Detection PAUSE BRADY AF Reveal LINQ™ NEW simplified insertion and tight pocket for better signal NEW AF algorithm with increased accuracy AF Reveal™ XT NEW AF algorithm and improved noise discrimination NEW Pause algorithm with diminishing R-wave analysis AF PAUSE With FullView ™ Software Reveal™ XT AF Industry’s first AF detection algorithm Notes for Reps: Medtronic has been the market leader in developing the most advanced and accurate arrhythmia detection algorithms available. Our engineers and scientists have continually improved each Reveal-brand ICM, making the detection algorithms better every few years as we introduced new models or enhanced a model’s capabilities with a firmware update. In 2009, the Reveal brand ICMs contained industry-leading Brady, Pause and Tachy detection algorithms inside an ICM. In 2009, Medtronic also introduced the world’s first AF detection algorithm inside an ICM, expanding a physician’s use of this important diagnostic tool to one of the hardest to detect and diagnose arrhythmias. In 2011, Medtronic introduces FullView Software, giving clinicians improved data viewing and collection capabilities. As part of this upgrade to the Reveal XT ICM, Medtronic also improved its AF detection algorithm, and enhanced the noise discrimination algorithm, allowing for ectopy rejection, and introduced a new Pause algorithm with the ability to analyze diminishing R-waves, among other advancements. In 2014, Medtronic introduced the revolutionary Reveal LINQ ICM, the world’s smallest, and first insertable cardiac monitor. The Reveal LINQ also significantly improved Medtronic’s AF detection algorithm, and improved a clinician’s overall experience with streamlined data management, reporting and patient management.. The Reveal LINQ also introduced daily, automatic wireless transmission of patient’s data from the inserted Reveal LINQ to the Medtronic CareLink network, assuring continuous rhythm information from patients to ensure timely notification of all clinically-relevant arrhythmias. And today, in 2017, Medtronic brings you TruRhythm™ Detection – the most advanced ICM intelligence available. The TruRhythm algorithms are a device firmware upgrade to the Reveal LINQ ICM. The new algorithms include AF, Brady and Pause sensing, filtering and detection algorithms, including new self-learning intelligence built into the TruRhythm AF detection algorithm. This new suite of algorithms has been designed to simplify ICM data and create a more efficient workflow for clinics. 2009 2011 2014 2017 1 TruRhythm™ Detection Efficiency. Medtronic data on file. 2017. 2 TruRhythm™ Detection Algorithms. Medtronic data on file. 2017. TruRhythm™ Detection Inside the Reveal LINQ™ ICM
TRURHYTHM™ Detection inside Work flow evolution Best-in-class data to streamline episode review1,2 TruRhythm™ Detection Improved accuracy and reporting for actionable data1 Reveal LINQ ™ Mobile Manager Reveal LINQSM Monitoring Service* Reveal LINQ ™ Education Programs NEW services and education Customized reports Wireless data enhancements User interface updates CareLink™ advancements All patient and clinical data are fictitious and for demonstration purposes only. Wireless data with CareAlerts Simplified reporting Reveal LINQ™ ICM Rep Notes: In the past few years since we released Reveal LINQ, we’ve worked closely with clinicians to improve several facets of their experience with long-term management of patients who have a Reveal LINQ ICM, including: Significant improvements in simplified data with the new TruRhythm suite of intelligent algorithms; A new patient education system and resources; The new Reveal LINQ Mobile Manager – an app-and-tablet based system for more efficient device management New clinician learning plans on Medtronic Academy to help you streamline the management of data in the CareLink System; and Upgrades and enhancements to the CareLink system to streamline ICM data management. 2014 2015 2016 2017 1 TruRhythm™ Detection Algorithms. Medtronic data on file. 2017. 2 TruRhythm™ Detection Efficiency. Medtronic data on file. 2017. *Available in select U.S. markets. 5 TruRhythm™ Detection Inside the Reveal LINQ™ ICM
TRURHYTHM™ DETECTION INSIDE THE JOURNEY TruRhythmTM Detection NEW exclusive and intelligent algorithms that streamline episode review1 Clinical need Clinicians said streamlined data was biggest need 50,000+ ECGs Over 50,000 real- world ECGs analyzed to increase device accuracy 1 TruRhythm™ Detection Algorithms. Medtronic data on file. 2017. TruRhythm™ Detection Inside the Reveal LINQ™ ICM
TRURHYTHM™ DETECTION INSIDE ACTIONABLE WORK FLOW EFFICIENCY false detects 54%*1 Streamlined episode review and reporting1,2 INTELLIGENT NEW ALGORITHMS Smart filtering Self-learning 1 TruRhythm™ Detection Algorithms. Medtronic data on file. 2017. 2 TruRhythm™ Detection Efficiency. Medtronic data on file. 2017. *Compared with the Reveal LINQ™ ICM without TruRhythm™ Detection TruRhythm™ Detection Inside the Reveal LINQ™ ICM
NEW ALGORITHMS Smart filtering Self-learning intelligence
TRURHYTHM™ INTELLIGENT DETECTION NEW ALGORITHMS SMART FILTERING Self-learning NEW second sensing filter analyzes rhythms for possible undersensing in Brady and Pause Exclusive fifth-generation atrial fibrillation algorithm learns and adapts to patient’s rhythm over time BRADY PAUSE & AF TruRhythm™ Detection Inside the Reveal LINQ™ ICM
TRURHYTHM™ INTELLIGENT DETECTION CLINICAL NEED Brady and pause episodes BRADY PAUSE & Reduce false detects from undersensing of PVCs1 Reduce false detects from undersensing of small R-waves1 PVCs example Small R-waves example Above image: Detection threshold of first sensing filter Result: PVC not detected due to undersensing Above image: Detection threshold of first sensing filter Result: Small R-waves not detected due to undersensing 1 TruRhythm™ Detection Algorithms. Medtronic data on file. 2017. 10 TruRhythm™ Detection Inside the Reveal LINQ™ ICM
TRURHYTHM™ INTELLIGENT DETECTION brady and pause solution Smart filtering algorithm BRADY PAUSE & Exclusive second filter rejects Brady and Pause episodes with: EVIDENCE OF PVCs EVIDENCE OF SMALL R-WAVES PVCs example Small R-waves example Above image: Threshold of new, second filter detects PVCs Result: ECG markers re-classified; false episodes rejected Above image: Threshold of new, second filter detects small R-waves Result: ECG markers re-classified; false episodes rejected 11 TruRhythm™ Detection Inside the Reveal LINQ™ ICM
TRURHYTHM™ INTELLIGENT DETECTION CLINICAL NEED AF Episodes AF Further enhance current AF algorithm to improve AF discrimination in patients with irregular sinus arrhythmias (sick sinus or PACs) CHALLENGE TODAY Algorithm cannot adapt based on a patient’s history AF detection algorithms based on R-wave variability alone inappropriately detect sick sinus or PACs The Reveal LINQ™ ICM’s P-Sense algorithm uniquely identifies P-waves and rejects false AF episodes P-Sense sometimes cannot identify P-waves in patients with irregular sinus rhythms TruRhythm™ Detection Inside the Reveal LINQ™ ICM
TRURHYTHM™ INTELLIGENT DETECTION AF solution Self-learning algorithm AF Exclusive fifth-generation AF algorithm learns and adapts to a patient’s daily rhythm 1. LEARNS 2. ADAPTS 3. REJECTS AF algorithm tracks R-wave variability in a patient and keeps their P-wave evidence history Self-learning algorithm collects P-wave evidence for a patient and adapts Self-learning algorithm rejects false AF in patients with irregular sinus TruRhythm™ Detection Inside the Reveal LINQ™ ICM
Work flow efficiency Episode reduction Report improvements
TRURHYTHM™ ACTIONABLE DETECTION STREAMLINED EPISODE REVIEW1 54% reduction in false detects*1 Significant reduction in episode review1 1 TruRhythm™ Detection Algorithms. Medtronic data on file. 2017. *Compared with the Reveal LINQ™ ICM without TruRhythm™ Detection TruRhythm™ Detection Inside the Reveal LINQ™ ICM
TRURHYTHM™ ACTIONABLE DETECTION FEWER FALSE DETECTS; Maintained SENSITIVITY1 BEST-IN-CLASS DATA Reduce episode review burden with fewer false detects1 Maintain clinical success without sacrificing sensitivity1 Reduction in false detects*1 Relative Sensitivity1 BRADY 95% 98.3%† PAUSE 47% 99.4%† AF** AF episode duration sensitivity used is ≥2 mins. 49% 99.1%† 1 TruRhythm™ Detection Algorithms. Medtronic data on file. 2017. *Compared with the Reveal LINQ™ ICM without TruRhythm™ Detection **In known AF patients † Relative sensitivity compared with the Reveal LINQ™ ICM without TruRhythm™ Detection TruRhythm™ Detection Inside the Reveal LINQ™ ICM
TRURHYTHM™ ACTIONABLE DETECTION Reporting improvements More ACTIONABLE AF reports 30 seconds of ECG for longest AF episodes 2 minutes of markers of longest AF episode AF episodes will show 30 seconds of ECG vs. 10 seconds, from wireless transmissions AF episodes will have ~2 minutes of intervals vs. 10 seconds, from wireless transmissions Notes for Reps: The overall impact of the TruRhythm suite of algorithms in the firmware of the Reveal LINQ ICM is significant. Across several arrhythmia types that you manage, from Brady to Pause and AF, you will experience a 54% relative reduction in the number of false positives episodes you receive. That means fewer calls to patients to request a manual transmission for longer duration strips, which equates to over 70% fewer patient manual transmissions. Also, an average clinic will spend $___ less due to less time committed to reviewing ICM data. And very important as well, a clinician will, on average, save ____% of time reviewing ICM data with Reveal LINQ with TruRhythm, compared with other ICMs. 17 TruRhythm™ Detection Inside the Reveal LINQ™ ICM
TRURHYTHM™ actionable Detection Time savings More efficient review Save clinician time with review of fewer false detects1,2 Estimated time reviewing false detects* Total Device Patients Monitored 56% Notes for Reps: The overall impact of the TruRhythm suite of algorithms in the firmware of the Reveal LINQ ICM is significant. Across several arrhythmia types that you manage, from Brady to Pause and AF, you will experience a 54% relative reduction in the number of false positives episodes you receive. That means fewer calls to patients to request a manual transmission for longer duration strips, which equates to over 70% fewer patient manual transmissions. Also, an average clinic will spend $___ less due to less time committed to reviewing ICM data. And very important as well, a clinician will, on average, save ____% of time reviewing ICM data with Reveal LINQ with TruRhythm, compared with other ICMs. Data Transmitted to Device Clinic less clinician time spent reviewing data*2 True Cardiac Events False Positive Events 1 TruRhythm™ Detection Algorithms. Medtronic data on file. 2017. 2 TruRhythm™ Detection Efficiency. Medtronic data on file. 2017. * Compared with Reveal LINQ™ ICM without TruRhythm™ Detection 18 TruRhythm™ Detection Inside the Reveal LINQ™ ICM
Nightly Data Transmissions TRURHYTHM™ actionable Detection Time savings calculation Average Event review time Manual Transmission (if needed) Clinician Review Physician Review TOTAL TIME + + = TruRhythm™ Detection improves report accuracy, resulting in a reduction of total clinician time spent reviewing false detect data*1,2 Notes for Reps: So, what was the journey that led us to develop this latest innovation in detection algorithms – the TruRhythm suite of algorithms? After the launch of Reveal LINQ in 2014, we incorporated a lot of informal and formal feedback from clinicians on ways we could continue to improve our ICM and the overall experience with long-term monitoring for clinicians. Repeatedly, what we heard was that the #1 way we could improvement the experience for clinicians was to streamline data from our ICMs. So, as part of this process, we formalized feedback from more than 200 physician and nurses focused on ways we could help them streamline data. So, we analyzed over 50,000 separate ECGs from our CareLink network to find most common false detects. The resulting efforts by our scientists and engineers is a completely re-vamped suite of filtering and detection algorithms known as the TruRhythm suite of algorithms in the newly-improved Reveal LINQ ICM. With the TruRhythm upgrade to Reveal LINQ, we’ve redesigned the algorithms inside the firmware of the Reveal LINQ ICM to improve detection specificity without compromising sensitivity to deliver industry-leading ICM detection. What this means is significant reduction in false positives across Brady, Pause and AF without sacrificing the high sensitivity clinicians have come to expect from Reveal LINQ. Why it Matters: With Reveal LINQ with TruRhythm, you can be confident you’re giving your patients the most advanced, accurate ICM available. Clinic review time calculated using data from: 56% 100K+ 1M+ Patients less clinician time spent reviewing data*2 Nightly Data Transmissions Reveal LINQ™ with TruRhythm™ Detection 1 TruRhythm™ Detection Algorithms. Medtronic data on file. 2017. 2 TruRhythm™ Detection Efficiency. Medtronic data on file. 2017. *Compared with Reveal LINQ™ ICM without TruRhythm™ Detection TruRhythm™ Detection Inside the Reveal LINQ™ ICM
Proven solution Clinical rigor Confidence across indications
Reveal™ ICM: Most Studied and Published days of real-world patient follow-up — the most of any ICM manufacturer1 Most clinically validated ICM in cryptogenic stroke, syncope, and atrial fibrillation patients2-4 50+ published detection performance papers5 500+ published clinical articles and abstracts6 1 Reveal LINQ™ ICM Days of Follow-Up. Medtronic data on file. 2017. 2 Sanders P, et al. Heart Rhythm. 2016;13(7):1425-1430. 3 Sanna T, et al. N Engl J Med. 2014;370(26):2478-2486. 4 Edvardsson N, et al. Europace. 2011;13(2):262-269. 5 Medtronic Reveal™ AF Publications. Medtronic data on file. 2016. 6 Medtronic Reveal™ Publications. Medtronic data on file. 2016. TruRhythm™ Detection Inside the Reveal LINQ™ ICM
TRURHYTHM™ PROVEN Detection Confidence across indications Syncope Why Reveal LINQ™ ICM? 78% of patients with recurrent syncope are diagnosed with an ICM3 Why TruRhythm™ Detection? Spend half the time reviewing false detect data, with significant improvement in Brady and Pause detections**2,4 Atrial fibrillation Why Reveal LINQ ™ ICM? Short and intermittent monitoring will likely miss many patients with paroxysmal AF1 Why TruRhythm ™ Detection? Manage AF patients over time with more actionable and accurate reports2 Cryptogenic stroke Why Reveal LINQ™ ICM? 88% percent of AF patients would be missed if monitoring stopped at 30 days*1 Why TruRhythm™ Detection? Don’t miss an AF episode† with high sensitivity and streamlined data review2 The Reveal LINQ ICM is guideline-recommended for Cryptogenic Stroke and Syncope5,6 1 Sanna T, et al. N Engl J Med. 2014;370(26):2478-2486. 2 TruRhythm™ Detection Algorithms. Medtronic data on file. 2017. 3 Edvardsson N, et al. Europace. 2011;13(2):262-269. 4 TruRhythm™ Detection Efficiency. Medtronic data on file. 2017. 5 Kirchhof P, et al. Eur Heart J. Published online August 27, 2016. Accessed online August 31, 2016. 6 Task Force for the Diagnosis and Management of Syncope, et al. Eur Heart J. November 2009;30(21):2631-2671. * Based on Kaplan Meier estimates † Episodes detected are ≥ 2 minutes ** Compared with the Reveal LINQ™ ICM without TruRhythm™ Detection TruRhythm™ Detection Inside the Reveal LINQ™ ICM
new intelligence to guide decisions TRURHYTHM™ DETECTION new intelligence to guide decisions actionable proven INTELLIGENT Exclusive NEW smart filtering and self-learning algorithms1 Best-in-class data to streamline episode review1 Most studied with 500+ clinical articles and abstracts2 1 TruRhythm™ Detection Algorithms. Medtronic data on file. 2017. 2 Medtronic Reveal™ Publications. Medtronic data on file. 2016. TruRhythm™ Detection Inside the Reveal LINQ™ ICM
Thank you
REFERENCES In order of appearance on slides 1 TruRhythm™ Detection Algorithms. Medtronic data on file. 2017. 2 TruRhythm™ Detection Efficiency. Medtronic data on file. 2017. 3 Reveal LINQ ICM Days of Follow-Up. Medtronic data on file. 2017. 4 Sanders P, Pürerfellner H, Pokushalov E, et al. Performance of a new atrial fibrillation detection algorithm in a miniaturized insertable cardiac monitor: Results from the Reveal LINQ Usability Study. Heart Rhythm. July 2016;13(7):1425-1430. 5 Sanna T, Diener HC, Passman RS, et al. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. June 26, 2014;370(26):2478-2486. 6 Edvardsson N, Frykman V, van Mechelin R, et al. Use of an implantable loop recorder to increase the diagnostic yield in unexplained syncope: results from the PICTURE registry. Europace. February 2011;13(2):262-269. 7 Medtronic Reveal™ AF Publications. Medtronic data on file. 2016. 8 Medtronic Reveal™ Publications. Medtronic data on file. 2016. 9 Kirchhof P, Benussi, S, Kotecha D, et al. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Eur J Cardiothorac Surg . November 2016; 50 (5): e1-e88. doi: 10.1093/ejcts/ezw313. First published online: September 23, 2016 . Task Force for the Diagnosis and Management of Syncope, European Society of Cardiology (ESC), European Heart Rhythm Association (EHRA), et al. Guidelines for the diagnosis and management of syncope (version 2009). Eur Heart J. November 2009;30(21):2631-2671. TruRhythm™ Detection Inside the Reveal LINQ™ ICM
Indications, Safety, and Warnings If you are located in the United States, please refer to the brief statement(s) below to review applicable indications, safety and warning information. 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 1.763.514.4000 and/or consult the Medtronic website at www.medtronic.com. If you are located outside the United States, see the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential adverse events. For further information, contact your local Medtronic representative and/or consult the Medtronic website at www.medtronic.com. Consult instructions for use at this website. Manuals can be viewed using a current version of any major Internet browser. For best results, use Adobe Acrobat Reader® with the browser. Important Reminder: This information is intended only for users in markets where Medtronic products and therapies are approved or available for use as indicated within the respective product manuals. Content on specific Medtronic products and therapies is not intended for users in markets that do not have authorization for use. TruRhythm™ Detection Inside the Reveal LINQ™ ICM
The device has not been tested specifically for pediatric use. Brief Statement Medtronic MyCareLinkTM Patient Monitor, CareLinkTM Network, CareLink Mobile Application, Reveal LINQTM Insertable Cardiac Monitor, Patient Assistanct, and Reveal LINQ Mobile Manager The Medtronic MyCareLink patient monitor and the Medtronic CareLink network are indicated for use in the transfer of patient data from Medtronic implantable cardiac devices. These products are not a substitute for appropriate medical attention in the event of an emergency. Data availability and alert notifications are subject to Internet connectivity and access, and service availability. The MyCareLink patient monitor must be on and in range of the device. Alert notifications are not intended to be used as the sole basis for making decisions about patient medical care. Brief Statement Reveal LINQ™ insertable cardiac monitor, Reveal LINQ Mobile Manager system, and Patient Assistant Indications: The Reveal LINQ insertable cardiac monitor (ICM) is an implantable patient-activated and automatically activated monitoring system that records subcutaneous ECG and is indicated in the following cases: Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias Patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia The device has not been tested specifically for pediatric use. Reveal LINQ Mobile Manager System The Reveal LINQ Mobile Manager app is intended for programming and interrogating the Reveal LINQ ICM LNQ11. The Medtronic 24965 patient connector is a portable electronic device using low-frequency inductive telemetry to communicate with the Reveal LINQ ICM. The patient connector uses Bluetooth® technology to transmit implantable heart device data to the Reveal LINQ Mobile Manager app for further processing. The patient connector is intended to be used by healthcare personnel only in a clinical or hospital environment. Patient Assistant The Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant activates the data management feature in the Reveal™ insertable cardiac monitor to initiate recording of cardiac event data in the implanted device memory. Contraindications: There are no known contraindications for the implant of the Reveal LINQ™ ICM or for the Reveal LINQ Mobile Manager system. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated. Warnings/Precautions Reveal LINQ Insertable Cardiac Monitor Patients with the Reveal LINQ ICM should avoid sources of diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, therapeutic ultrasound, and radio frequency ablation to avoid electrical reset of the device, and/or inappropriate sensing as described in the Medical Procedure and EMI Precautions manual. MRI scans should be performed only in a specified MR environment under specified conditions as described in the Reveal LINQ MRI Technical Manual. TruRhythm™ Detection Inside the Reveal LINQ™ ICM
Brief Statement (cont’d) Medtronic MyCareLinkTM Patient Monitor, CareLinkTM Network, CareLink Mobile Application, Reveal LINQTM Insertable Cardiac Monitor, Patient Assistanct, and Reveal LINQ Mobile Manager Reveal LINQ Mobile Manager System Before inserting the Reveal LINQ ICM, verify that the patient connector and mobile device are fully charged. The patient connector and mobile device may run out of power during the insertion procedure if they are not fully charged. You will not be able to program or interrogate the patient’s Reveal LINQ ICM until the patient connector and the mobile device have power. Only use the patient connector to communicate with the intended implanted device. Do not use the patient connector to communicate with other implanted devices. Using the patient connector to communicate with other implanted devices can interfere with those devices, potentially affecting the other implanted device’s functionality or therapy delivery. Use of wireless devices — The patient connector incorporates radiofrequency (RF) communications components which may affect other devices and equipment in the medical environment. The use of wireless devices in the medical environment must be evaluated and authorized by the responsible organization. RF interference may affect device performance. Electromagnetic Compliance (EMC) testing shows that the patient connector provides reasonable protection against harmful interference and provides EMC immunity in a typical medical installation. The use of wireless devices in the medical environment must be evaluated and authorized by the responsible organization. However, there is no guarantee that interference will not occur in a particular installation. If the patient connector does cause harmful interference to other devices or is negatively impacted by other devices, correct the interference by one or more of the following measures: Reorient or relocate the patient connector and other devices; increase the separation between the patient connector and other devices by at least two meters (approximately six feet); and/or turn off any interfering equipment. Radiofrequency (RF) interference — Portable and mobile RF communications equipment can interfere with the operation of the patient connector. There is no guarantee that it will not receive interference or that any particular transmission from this system will be free from interference. To avoid interference, do not use the patient connector and mobile device within two meters (six feet) of other wireless communications equipment. Using the patient connector near these devices could interfere with communication between the Reveal LINQ ICM and the patient connector. Security — Maintain adequate physical security of the patient connector to prevent unauthorized use that could lead to harm to patients. Bluetooth® communication in the patient connector is encrypted for security. Medtronic inductive telemetry uses short-range communication to protect patient information. If the patient connector should fail, there is no risk of patient harm. Environmental precautions — To ensure safe and effective operation, use the device with care to avoid damage to the patient connector from environmental factors that may impair its function. Care is exercised in design and manufacturing to minimize damage to devices under normal use. However, electronic devices are susceptible to many environmental stresses. Specifically, the patient connector may be affected by electrostatic discharge (ESD). In an environment likely to cause ESD, such as a carpeted floor, discharge any charge collected on your body before touching the device. Patient Assistant Operation of the Patient Assistant near sources of electromagnetic interference, such as cellular phones, computer monitors, etc., may adversely affect the performance of this device. TruRhythm™ Detection Inside the Reveal LINQ™ ICM
Brief Statement (cont’d) Medtronic MyCareLinkTM Patient Monitor, CareLinkTM Network, CareLink Mobile Application, Reveal LINQTM Insertable Cardiac Monitor, Patient Assistanct, and Reveal LINQ Mobile Manager Potential Complications: Potential complications of the Reveal LINQ device include, but are not limited to, device rejection phenomena (including local tissue reaction), device migration, infection, and erosion through the skin. Medtronic MyCareLink™ Patient Monitor, Medtronic CareLink™ Network, and CareLink Mobile Application Intended Use: The Medtronic MyCareLink patient monitor and CareLink network are indicated for use in the transfer of patient data from some Medtronic implantable cardiac devices based on physician instructions and as described in the product manual. The CareLink Mobile Application is intended to provide current CareLink network customers access to CareLink network data via a mobile device for their convenience. The CareLink Mobile Application is not replacing the full workstation but can be used to review patient data when a physician does not have access to a workstation. These products are not a substitute for appropriate medical attention in the event of an emergency and should only be used as directed by a physician. CareLink network availability and mobile device accessibility may be unavailable at times due to maintenance or updates, or due to coverage being unavailable in your area. Mobile device access to the Internet is required and subject to coverage availability. Standard text message rates apply. Contraindications: There are no known contraindications. Warnings and Precautions: The MyCareLink patient monitor must only be used for interrogating compatible Medtronic implantable devices. See the device manuals 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 the Medtronic website at medtronic.com. Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician. Medtronic 710 Medtronic Parkway Minneapolis, MN 55432 USA Toll-free in USA: 800.633.8766 Worldwide: +1 763 514 4000 medtronic.com UC201706069a EN ©2017 Medtronic Cardiac Rhythm and Heart Failure Minneapolis, MN. All Rights Reserved. 01/2017 Medtronic, Medtronic logo, and Further, Together are trademarks of Medtronic. ™Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company. TruRhythm™ Detection Inside the Reveal LINQ™ ICM