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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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Alert Indications, Safety, and Warnings

Reveal LINQ™ Insertable Cardiac Monitor

The Reveal LINQ insertable cardiac monitor (ICM) is a wireless and powerfully small insertable cardiac monitor ideal for patients experiencing infrequent symptoms that require long-term monitoring or ongoing management.

Download Brochure
Close-up view of the front side of the Reveal LINQ insertable cardiac monitor
Alert Indications, Safety, and Warnings

Overview

The World's Smallest, Most Accurate Insertable Cardiac Monitor1,2

The Reveal LINQ ICM system provides innovative ways to allow you to focus on what matters most — patient care.

Product Features

Powerfully Small and Simple

  • The Reveal LINQ ICM is one-third the size of a AAA battery (1.2 cc).
  • It has a minimally invasive, simplified insertion procedure.
  • The device is 1.5T and 3T MRI conditional.*

*Reveal LINQ has demonstrated to pose no known hazards in a specified MRI environment with specified conditions of use. Please see the Reveal LINQ MRI Technical Manual for more details.

Proven ICM Technology

  • TruRhythm™ Detection inside Reveal LINQ ICM features the world's most accurate AF detection algorithm.2
  • 700+ published clinical articles and abstracts for the Reveal™ family of ICMs.3

View the ICM Insertion Procedure Animation

Patient Monitoring Solutions

Exclusive Services and Solutions

Horizontal diagram that shows the exclusive services and solutions that correspond with the Reveal LINQ ICM

1. Streamline Device Programming and Interrogation

Reveal LINQ Mobile Manager
A single, app-based solution for managing:

  • Device registration, activation, and CareLink™ pre-enrollment
  • Guided workflow animations
  • Integrated patient education
Discover More

2. World's Smallest, Most Accurate ICM1,2

Reveal LINQ ICM with TruRhythm Detection
The Reveal LINQ ICM is part of the exclusive services and solutions designed to get you back to caring for patients.

3. Direct Support for Patient Monitor Connectivity Issues

Medtronic Stay Connected Service
A specialized patient service for monitor troubleshooting, connectivity issues, and other questions:

Direct patient line for fast service (1-866-470-7709)

7 a.m.–7 p.m. CT, Monday–Friday

4. Customize Alerts for Clinically Actionable Reports

CareLink Network
A remote monitoring network that enables data-driven care decisions:

  • CareAlert™ notifications allow for customized reports by clinic and/or individual patient
  • Cardiac Compass™ report provides a 90-day view of patient cardiac data
View Details

5. Expert Operational Support to Help Manage Patients

Medtronic FocusOn℠ Monitoring Service†
A remote monitoring service that helps optimize your time:

  • Ensures data transmissions through patient management and communication
  • Patient cardiac data review by certified technicians
  • Clinically actionable reporting to inform treatment decisions
Learn More

†Medtronic FocusOnSM Monitoring Service is provided by Medtronic Monitoring Inc., a wholly owned subsidiary of Medtronic.

Monitoring Data

Long-term Monitoring for Better Patient Outcomes

The Reveal LINQ ICM continuously monitors patients for up to 3 years.‡ Learn more about long-term heart monitoring for suspected AF, syncope, and cryptogenic stroke.

 

30 Days Is Not Enough

2 Years Is Not Enough

Superior Diagnostic Yield

Informed Treatment Decisions

Cryptogenic Stroke
(CRYSTAL-AF Study)§

 

88%

of patients who had AF would have been missed if only monitored for 30 days ll4

30%

of cryptogenic stroke AF diagnoses occur between years 2 and 34

8.8x

more AF detected at 36 months with ICM vs. conventional follow-up¶4

97%

of patients in whom AF was detected received oral anticoagulants at 12 months4

Syncope

ICM recommended for syncopal episodes
> 30 days apart5

20%

of syncope diagnoses occur between years 2 and 37

3.6x

more likely to reach a syncope diagnosis with ICM vs. conventional care#8

82%

of Reveal ICM guided diagnoses led to treatment10

Suspected AF (REVEAL AF Study)**

84.5%

of patients with AF would have been missed if only monitored for 30 days6

16%

of patients with ICM-detected AF would be missed if monitoring stopped at 2 years6

4.3x

more likely to reach a diagnosis with ICM in 12 months vs. one-time, 30-day monitor9

76%

of patients with ICM-detected AF had a change in clinical management6

‡Reference the Reveal LINQ ICM Clinician Manual for usage parameters.
§The CRYSTAL-AF Study was a randomized, controlled study conducted on 441 patients to assess whether long-term monitoring with Reveal XT is more effective than conventional follow-up (control) for detecting atrial fibrillation in patients with cryptogenic stroke.
llBased on Kaplan-Meier estimates.
In the CRYSTAL-AF study, the control group included 88 conventional ECGs, 20 24-hour Holters, and 1 event recorder.
#2018 ESC Guidelines for Diagnosis and Management of Syncope defined conventional testing as undefined physician discretion for monitoring excluding ICM, External Loop Recorder, Tilt Test, EP Study, Recurrent 12-lead ECG, or 7-day Holter monitor.
**The REVEAL AF Study was a prospective, single-arm, multicenter study to quantify the incidence of AF in patients at high risk for but without previously known AF using an ICM (Reveal LINQ or Reveal XT).

Advanced Detection Algorithms

Unmatched Accuracy

Reduce false episode review burden while maintaining high sensitivity.11

Discover more about the device innovations that provide leading detection accuracy.

Industry-leading TruRhythm Algorithms

Our TruRhythm detection algorithms streamline episodes without sacrificing sensitivity.

Small box with the words bradycardia and pause detection on blue backgrounds

Smart Filtering

Second sensing filter analyzes rhythms for possible undersensing in bradycardia and pause detection.

Small navy blue box with the letters AF inside

Self-learning

AF algorithm learns and adapts to patients with sinus arrhythmia.

pdf TruRhythm Detection Technical Overview (.pdf)

View the PDF to learn more about TruRhythm detection inside the Reveal LINQ insertable cardiac monitor.

161KB

Document thumbnail

Superior Accuracy in AF Detection

Experience fewer false alerts11 with the Reveal LINQ ICM with TruRhythm Detection.

Lowest Published Rate of  AF False Episodes††11-14

4.7%

AF False Positive Rate††11

Chart demonstrating that the Reveal LINQ ICM has the lowest published rate of AF false episodes

Disclaimer: A controlled, head-to-head study evaluating the comparative performance of these devices has not been done.

††Based on AF episodes ≥ 2 minutes and in known AF patients. % of false positives = (1 – episode PPV). AF episodes PPV may vary between gross and patient average.
‡‡Lux-Dx™ ICM, Confirm Rx™ with SharpSense™ technology, and BIOMONITOR™ III have no published clinical evidence showing AF episode PPV or AF sensitivity.

TruRhythm Global Grand Rounds Webinar

An electrophysiologist, a device nurse, and a Medtronic scientist discuss the TruRhythm algorithms and their impact from an EP and nurse perspective.

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Model Specifications

pdf Reveal LINQ ICM Specifications (.pdf)

Download the specifications sheet for details on the Reveal LINQ insertable cardiac monitor.

Document thumbnail

Indications

The Reveal LINQ Insertable Cardiac Monitor 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, which may suggest a cardiac arrhythmia

This device has not been specifically tested for pediatric use.

Additional Resources

Manuals and Technical Guides

Access prescriber, implant, MRI, and other manuals on the Medtronic Manual Library. Search by the product name (Reveal LINQ) or model number (LNQ11). You may also call 800-961-9055 for a copy of a manual.

Product manuals

Access product manuals from the Medtronic Manual Library by searching for the product name or model number.

Visit Library

References

1

ICM Size Comparison Guide. Medtronic data on file. 2021. 

2

ICM Accuracy Comparison Guide. Medtronic data on file. 2021.

3

Medtronic Reveal™ Publications. Medtronic data on file. 2021.

4

Sanna T, Diener H-C, Passman RS, et al. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. June 26, 2014;370(26):2478-2486.

5

Writing Committee Members, Schoenfeld MH, Barrett C, et al. 2018 ACC/AHA/HRS guideline on the evaluation and management of patients with bradycardia and cardiac conduction delay: Executive summary: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines, and the Heart Rhythm Society. Heart Rhythm. September 2019;16(9):e227-e279.

6

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.

7

Furukawa T, Maggi R, Bertolone C, Fontana D, Brignole M. Additional diagnostic value of very prolonged observation by implantable loop recorder in patients with unexplained syncope. J Cardiovasc Electrophysiol. January 2012;23(1):67-71.

8

Brignole M, Moya A, de Lange FJ, et al. 2018 ESC Guidelines for the diagnosis and management of syncope. Eur Heart J. June 1, 2018;39(21):1883-1948.

9

Reiffel JA, Verma A, Kowey PR, et al. Rhythm monitoring strategies in patients at high risk for atrial fibrillation and stroke: A comparative analysis from the REVEAL AF study. Am Heart J. January 2020;219:128-136.

10

Edvardsson N, Frykman V, van Mechelen 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.

11

Pürerfellner H, Sanders P, Sarkar S, et al. Adapting detection sensitivity based on evidence of irregular sinus arrhythmia to improve atrial fibrillation detection in insertable cardiac monitors. Europace. November 2018;20(FI_3):f321-f328.

12

Confirm Rx™ ICM DM3500 FDA Clearance Letter. 2017.

13

Nölker G, Mayer J, Boldt L-H, et al. Performance of an Implantable Cardiac Monitor to Detect Atrial Fibrillation: Results of the DETECT AF Study. J Cardiovasc Electrophysiol. December 2016;27(12):1403-1410.

14

BIOTRONIK BioMonitor™ 2 Technical Manual. 2017.