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View Indications, Safety, and Warnings

Indications, safety, and warnings
Cardiac diagnostics and monitoring systems

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Brief statement for Medtronic LINQ II insertable cardiac monitor system (ICM) and remote monitoring

Indications
The LINQ II ICM is an insertable automatically-activated and patient-activated monitoring system that records subcutaneous ECG and is indicated in adult patients, and in pediatric patients who are at least 2 years old, 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

Contraindications
There are no known contraindications for the insertion of the LINQ II ICM or its accessories. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically inserted device can be tolerated.

Warnings and Precautions
Patients with the LINQ II ICM should avoid sources of diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, therapeutic ultrasound and radiofrequency ablation to avoid electrical reset of the device, and/or inappropriate sensing as described in the Medical procedure and EMI Warnings, Precautions and Guidance Manual. MRI scans should be performed only in a specified MR environment under specified conditions as described in the LINQ II MRI Technical Manual.

Wireless accessories available for use with LINQ II may experience connectivity or performance issues. See product manuals for details and troubleshooting instructions.

Potential Adverse Events
Potential adverse events from the LINQ II ICM include, but are not limited to, device rejection phenomena (including local tissue reaction), device migration, infection, and erosion through the skin.

There are no known adverse events associated with the use of any LINQ II ICM wireless accessory.

See the device manuals for detailed information regarding the implant procedure, indications/intended use, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 800-328-2518 (Technical Services), 800-551-5544 (Patient Services), and/or consult Medtronic’s website at www.medtronic.com.

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

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 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.

Reveal LINQ Insertable Cardiac Monitor

Warnings/Precautions: Patients with the Reveal LINQ ICM should avoid sources of diathermy, high sources of radiation, electrosurgical cautery, external defibrillation, lithotripsy, therapeutic ultrasound, and radiofrequency 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.

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 6 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 2 m (6 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.

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.

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 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 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 manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 800-929-4043 and/or consult the Medtronic website at medtronic.com.

AccuRhythm AI ECG classification system brief statement

Indications: The intended use of the system is to reduce false positive cardiac arrhythmia episodes.

Contraindications: There are no known contraindications for AccuRhythm AI Models ZA400, ZA410, or ZA420.

Precautions: The AccuRhythm AI ECG classification system may incorrectly adjudicate a true positive episode as an AI false episode, causing that episode to be suppressed in the remote monitoring system.

See the device manual for detailed information regarding the intended use, contraindications, warnings, precautions, and potential complications/adverse events. For further information, call Medtronic Technical Services at 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.

The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Medtronic is under license.

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Atrial Fibrillation Patient

SUSPECTED ATRIAL FIBRILLATION CARDIAC DIAGNOSTICS & MONITORING

Make the connection between atrial fibrillation and heart palpitations for patients at high risk

Atrial Fibrillation & Stroke:
A Global Health Challenge

Atrial fibrillation (AF or AFib) is the most common sustained heart rhythm disorder and increases the risk for heart disease and stroke, both leading causes of death1

15 million people worldwide experience a stroke each year

AF Detection and Treatment Matters

  

5-fold increase in ischemic stroke risk for AF patients - 2x more likely for AF-related ischemic stroke to be fatal as non-AF stroke - 67% decrease in AF patient stroke risk with oral anticoagulants

DIFFICULTIES IN AF DETECTION

  

~90% of AF episodes may be asymptomatic - ~30% of AF is paroxysmal - Stroke is the first symptom for -20% of patients who have an AF-related stroke

Short-term and intermittent cardiac monitoring may miss many patients with paroxysmal AF7-9

  • Short-term monitoring via 24-hour Holter has low sensitivity and negative predictive value for AF detection.7
  • Intermittent and symptom-based monitoring has a significantly lower sensitivity and negative predictive value for AF detection compared with continuous monitoring.8

Longer, continuous monitoring periods result in higher AF detection.9

Are you monitoring high-risk patients long enough?

Detection rate of patients with AF of ≥ 6 minutes in duration10

AF detection Rate (%) over number of months post-insertion
40% AF detection rate in high-risk patients at 30 months - 123 Days was the median time to AF detection in high-risk patients - 85% of patients with AF would have been missed if only monitored for 30 days

SUPERIOR DIAGNOSTIC YIELD

12 Month Estimated AF Detection Rates for One-time, Repeated, and Continuous Monitoring11-14

Incidence of AF detected (%) over one-time monitoring, repeated monitoring and continuous monitoring
  • The AF incidence rate via ICM at 12 months was 27.1%.
  • This exceeded range of estimated rates from all forms of simulated IM (1.1-13.5%).

95% CI included for ICM and one-time monitoring incidence rates.

Range included for repeated monitoring incidence rates.

AF & STROKE: RISK FACTORS15,16

CHADS2 Score: Evaluates ischemic stroke risk in patients with AF
  • Congestive heart failure
  • Hypertension
  • Age
  • Diabetes
  • Stroke/TIA/ thromboembolism

SOCIETY RECOMMENDATIONS & GUIDELINES

INSERTABLE CARDIAC MONITORING

EHRA Recommendations17

The European Heart Rhythm Association (EHRA) recommends insertable loop recorders (insertable cardiac monitors) like Reveal LINQ™ ICM for palpitations for the following indications:

  • Increasing monthly in frequency
  • Associated with hemodynamic compromise
  • Other listed examinations prove inconclusive
  • Non-compliant patients without hemodynamic compromise when a clinically significant arrhythmic cause is likely or must be ruled out
ERHA recommendations flow chart

ACC/AHA Ambulatory ECG Guidelines 200018

These guidelines represent some of the current common clinical uses of ambulatory ECG.

For Assessment of Symptoms of Cardiac Arrhythmias

Class Recommended Use

I
  1. Patients with unexplained syncope, near syncope, or episodic dizziness without obvious cause.
  2. Patients with unexplained recurrent palpitation.

IIb
  1. Patients with episodic shortness of breath, chest pain, or fatigue that is not otherwise explained.
  2. Patients with neurologic events when transient atrial fibrillation or flutter is suspected.
  3. Patients with symptoms such as syncope, near syncope, episodic dizziness, or palpitation in whom a probable cause other than an arrhythmia has been identified but in whom symptoms persist despite treatment of this other cause.

Indications for AECG to Assess Symptoms Possibly Related to Rhythm Disturbances

Class Recommended Use

I
  1. Patients with unexplained syncope, near syncope, or episodic dizziness without obvious cause.
  2. Patients with unexplained recurrent palpitation.

IIb
  1. Patients with episodic shortness of breath, chest pain, or fatigue that is not otherwise explained.
  2. Patients with neurologic events when transient atrial fibrillation or flutter is suspected.
  3. Patients with symptoms such as syncope, near syncope, episodic dizziness, or palpitation in whom a probable cause other than an arrhythmia has been identified but in whom symptoms persist despite treatment of this other cause.

Evidence for Cardiac monitoring

Reveal ICM: Clinical and Cost Effectiveness19

Higher Diagnostic Yield, Lower Cost for Palpitations Diagnosis

Reveal ICM has been shown to be both clinically effective and cost effective when treating palpitations.

Results of the RUP study show:

  • A 73% diagnostic yield for Reveal ICM, compared to a 21% yield for conventional tests
  • Conventional testing arm was 121% more expensive than ICM arm.
rup study palpitation chart
CLICK TO SEE THE EVIDENCE
1

World Heart Federation statistics. http://www.world-heart-federation.org/cardiovascular-health/stroke/.

2

Benjamin EJ, Blaha MJ, Chiuve SE, et al. Heart Disease and Stroke Statistics — 2017 Update. A Report From the American Heart Association. Circulation. March 7, 2017;135(10):e146-e603.

3

Lin HJ, Kelly-Hayes M, Beiser AS, et al. Stroke severity in atrial fibrillation: The Framingham Study. Stroke. October 1996;27(10):1760-1764.

4

Stroke Prevention in Atrial Fibrillation Study. Final results. Circulation. August 1991;84(2):527-539.

5

Strickberger SA, Ip J, Saksena S, et al. Relationship between atrial tachyarrhythmias and symptoms. Heart Rhythm. February 2005;2(2):125-131.

6

Chiang CE, Naditch-Brûlé L, Murin J, et al. Distribution and risk profile of paroxysmal, persistent, and permanent atrial fibrillation in routine clinical practice: insight from the real-life global survey evaluating patients with atrial fibrillation international registry. Circ Arrhythm Electrophysiol. August 1, 2012;5(4):632-639.

7

Hanke T, Charitos EI, Stierle U, et al. Twenty-four-hour holter monitor follow-up does not provide accurate heart rhythm status after surgical atrial fibrillation ablation therapy: up to 12 months experience with a novel permanently implantable heart rhythm monitor device. Circulation. September 15, 2009;120(11 Suppl):S177-S184.

8

Ziegler PD, Koehler JL, Mehra R. Comparison of continuous versus intermittent monitoring of atrial arrhythmias. Heart Rhythm. December 2006;3(12):1445-1452.

9

Jabaudon D, Sztajzel J, Sievert K, Landis T, Sztajzel R. Usefulness of ambulatory 7-day ECG monitoring for the detection of atrial fibrillation and flutter after acute stroke and transient ischemic attack. Stroke. July 2004;35(7):1647-1651.

10

Reiffel JA, Verma A, Kowey PR, et al. High Incidence of Previously Unknown (“Silent”) Atrial Fibrillation in Patients at High Risk for Atrial Fibrillation and Stroke: Primary Results from the REVEAL AF Study. Abstract presented at Heart Rhythm Society Annual Scientific Sessions. 2017.

11

Reiffel JA, Verma A, Kowey PR, et al. Incidence of Previously Undiagnosed Atrial Fibrillation Using Insertable Cardiac Monitors in a High-Risk Population: The REVEAL AF Study. JAMA Cardiol. October 1, 2017;2(10):1120-1127.

12

Nasir JM, Pomeroy W, Marler A, et al. Predicting Determinants of Atrial Fibrillation or Flutter for Therapy Elucidation in Patients at Risk for Thromboembolic Events (PREDATE AF) Study. Heart Rhythm. July 2017;14(7):955-961.

13

Healey JS, Alings M, Ha A, et al. Subclinical Atrial Fibrillation in Older Patients. Circulation. October 3, 2017;136(14):1276-1283.

14

Philippsen TJ, Christensen LS, Hansen MG, Dahl JS, Brandes A. Detection of Subclinical Atrial Fibrillation in High-Risk Patients Using an Insertable Cardiac Monitor. JACC Clin Electrophysiol. December 26, 2017;3(13):1557-1564.

15

January CT, Wann LS, Alpert JS, et al. 2014 AHA/ACC/HRS guideline for the management of patients with atrial fibrillation: executive summary: a report of the American College of Cardiology/American Heart Association Task Force on practice guidelines and the Heart Rhythm Society. Circulation. December 2, 2014;130(23):2071-2104.

16

Kirchhof P, Benussi S, Kotecha D, et al. 2016 ESC Guidelines for the management of atrial fibrillation developed in collaboration with EACTS. Europace. November 2016;18(11):1609-1678.

17

Raviele A, Giada F, Bergfeldt L, et al. Management of patients with palpitations: a position paper from the European Heart Rhythm Association. Europace. July 2011;13(7):920-934.

18

ACC/AHA Guidelines for Ambulatory Electrocardiography: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines (Committee to Revise the Guidelines for Ambulatory Electrocardiography). JACC. 1999.

19

Giada F, Gulizia M, Francese M, et al. Recurrent unexplained palpitations (RUP) study comparison of implantable loop recorder versus conventional diagnostic strategy. J Am Coll Cardiol. May 15, 2007;49(19):1951-1956.