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Indications, Safety, & 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) with AccuRhythm™ AI algorithms is for patients experiencing infrequent symptoms that require long-term monitoring.

View video
Close-up view of the front side of the Reveal LINQ™ insertable cardiac monitor
Alert Indications, Safety, and Warnings

Overview

Accuracy matters 

As one of the world's smallest ICMs,1-3 the Reveal LINQ™ ICM works continuously to capture comprehensive and actionable data up to three years.† The device features AccuRhythm™ AI algorithms, which is a groundbreaking platform that applies deep learning artificial intelligence algorithms to Reveal LINQ™ data flowing into the CareLink™ network.

† Reference the Reveal LINQ™ ICM clinician manual for usage parameters.

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.

One-third the size of a AAA battery

Reveal LINQ™ ICM next to a AAA battery to compare size with purple and blue particles in background

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AccuRhythm AI algorithms

Experience the difference of Reveal LINQ™ ICM now with AccuRhythm™ AI algorithms for AF and pause.

Reveal LINQ™ ICM,4 the most studied ICM in the market — trusted in over 1 million implants4 is now enhanced with proven AI, providing smarter, more actionable data — without compromise. Preserving over 99.9% true pause and 98.2% true AF alerts relative to Reveal LINQ™ ICM, AccuRhythm™ AI algorithms significantly improve the clinic experience.5

Download brochure
Reveal LINQ™ ICM with an ECG strip running through it on navy and orange conceptual background

Watch our video to learn more about AccuRhythm™ AI algorithms.


How are AccuRhythm™ AI algorithms applied?

Data workflow

The AccuRhythm™ AI platform applies deep learning AI algorithms to Reveal LINQ™ ICM data flowing into the CareLink™ network to remove false AF and Pause episodes and significantly reduce clinic review burden.5

Graphic showing data flowing from the Reveal LINQ™ ICM to a cloud representing AccuRhythm™ AI to the CareLink™ network
  1. Reveal LINQ™
  2. Data to the cloud
  3. Medtronic CareLink™ network
  4. AF and Pause
  5. AccuRhythm™ AI algorithms
  6. False events
  7. True/Indeterminate events

Reduce false alerts while maintaining sensitivity

AF and Pause generate ~90% of false alerts in the ICM space.6

The AccuRhythm™ AI algorithms can save clinicians approximately 102 hours of false alert review yearly for every 100 Reveal LINQ™ ICM patients.§,◊,5

85% cumulative reduction in Reveal LINQ™ ICM false alerts.5

  • 99.9% preserved true pause alerts5
  • 98.2% preserved true AF alerts5
Chart showing data for false Pause and AF alert reduction with the Reveal LINQ™ ICM

§ The validation study performance and time study results were projected onto 86,383 Reveal LINQ patients to calculate false alert reduction per year in 100 Reveal LINQ ICM patients.

◊ Estimated time savings was calculated based on 11.3 minutes per non-actionable ICM transmission.6

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Exclusive services and solutions

AI 3.0 PI LINQ Reveal

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. One of the world’s smallest, most accurate
ICMs.1–3

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

 

5. FocusOn™ Monitoring and Triaging Service

Staffed with certified ECG device specialists and cardiologists, our service filters out non-actionable transmissions and alerts you to only the 20% of data that requires clinical action.16-19

Freeing up time for you to concentrate on the patients who need it most.16-19

3. Direct support for patient monitor connectivity issues.

BeConnected Patient Service

Our patient telephone support service frees up clinic time by providing answers to patient ICM and monitoring questions.14,15

 

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

Proven ICM technology

  • TruRhythm™ Detection inside Reveal LINQ™ ICM features the world's most accurate AF detection algorithm3
  • 1,000+ published clinical articles and abstracts for the Reveal™ family of ICMs4

View the ICM insertion procedure animation.

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Monitoring data

Long-term monitoring for better patient outcomes.

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

Benefits of continuous monitoring and automatic arrhythmia detection with ICMs

 

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#,7

17.6%

of cryptogenic stroke AF diagnoses occur after monitoring with an ICM for 1 and 3 years7

8.8x

more AF detected at 36 months with ICM vs. conventional follow-upΔ,7

97%

of patients in whom AF was detected received oral anticoagulants at 12 months7

Syncope

74%

of syncope diagnoses would have been missed if using a 30-day monitor strategy#,8

20%

of syncope diagnoses occur between years 2 and 39

3.6x

more likely to reach a syncope diagnosis with ICM vs. conventional care∞,10

82%

of Reveal™ ICM guided diagnoses led to treatment11

High-risk for AF (REVEAL AF study)††

84.5%

of patients with AF would have been missed if only monitored for 30 days12

16%

of patients with ICM-detected AF would have been missed if monitoring stopped at 2 years12

4.3x

more likely to reach a diagnosis with ICM in 12 months vs. one-time, 30-day monitor13

76%

of patients with ICM-detected AF had a change in clinical management12

Watch an out-of-lab procedure

Practical guide: Reveal LINQTM in a procedure room

Download the guide to learn about best practices for safe implantation and management of Insertable Cardiac Monitors (ICMs) by nurses or other healthcare professionals in a procedure room

Download guide
FIND OUT MORE ABOUT LINQ II™
Visit Medtronic Academy to view all webinars from this series

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† Reference the Reveal LINQ™ ICM clinician manual for usage parameters.

‡ 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.

§ The validation study performance and time study results were projected onto 104,315 Reveal LINQ™ patients to calculate false alert reduction per year in 200 Reveal LINQ™ ICM patients.

◊ Estimated time savings was calculated based on 11.3 minutes per non-actionable ICM transmission.6

¶ 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.

#Based on Kaplan-Meier estimates.

Δ 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).

1. Reveal LINQ™ insertable cardiac monitor clinician manual.

2. Assert-IQ™ Model DM5000, DM5300, DM5500, insertable cardiac monitor manual. 2023.

3. ICM accuracy comparison guide. Medtronic data on file. 2021.

4. Medtronic Reveal™ ICM family data. Data on file. 2024.

5. Radtke A, Ousdigian K, Koehler J, Margetta J, Han J K. AI Enables Significant Reduction of Clinic Review Burden for Legacy ICMs. Presented HRS 2024, Boston, MA.

6. O’Shea CJ, Middeldorp ME, Hendriks JM, et al. Remote monitoring of implantable loop recorders: false-positive alert episode burden. Circ Arrhythm Electrophysiol. 2021;14(11):e009635. doi: 10.1161/CIRCEP.121.009635.

7. Sanna T, Diener H-C, Passman RS, et al. Cryptogenic stroke and underlying atrial fibrillation. N Engl J Med. 2014;370(26):2478–2486. doi: 10.1056/NEJMoa1313600.

8. Rogers J, et al. Abstract 272: Sensitivity of conventional monitoring strategies to diagnose patients with pause arrhythmias relative to insertable cardiac monitors. 2020 AHA QCOR Abstract.

9. 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. 2012;23(1):67–71. doi: 10.1111/j.1540-8167.2011.02133.x.

10. Brignole M, Moya A, de Lange FJ, et al. 2018 ESC guidelines for the diagnosis and management of syncope. Eur Heart J. 2018;39(21):1883–1948. doi: 10.1093/eurheartj/ehy037.

11. 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. 2011;13(2):262–269. doi: 10.1093/europace/euq418.

12. 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. 2017;2(10):1120–1127. doi: 10.1001/jamacardio.2017.3180.

13. 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. 2020;219:128–136. doi: 10.1016/j.ahj.2019.07.016.

14. BeConnected Day to Day Service - Call Time Analysis. June 2022. Medtronic Data On File.

15. BeConnected Onboarding Pilot Results - based on 104 patients. December 2020. Medtronic Data on File.

16. Cronin et al, 2012, Heart Rhythm, vol 9, n°12.

17. Giannola et al, JMIR Cardio 2019;3(2):e9815.

18. Seiler A, et al. Clinic time required for remote and in-person management of patients with cardiac devices: Time and motion workflow evaluation. JMIR Cardio. 2021;5(2):e27720.

19. Nicolle E, et al. Clinic time required to manage remote monitoring of cardiac implantable electronic devices: impact of outsourcing initial data review and triage. EP Europace. 2021;23(Supplement_3):euab116-519.

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