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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

LINQ II™ insertable cardiac monitor for cardiac monitoring

The LINQ II™ insertable cardiac monitor (ICM) with AccuRhythm™ AI algorithms is used for long-term heart monitoring.

Download brochure
LINQ II™ insertable cardiac monitor on transparent background
Alert Indications, Safety, and Warnings

Overview

Accuracy matters

The LINQ II™ ICM is the most advanced ICM system, featuring enhanced artificial intelligence (AI) algorithms, remote programming, and 4.5-year† longevity.1

LINQ II™ ICM is ideal for patients experiencing infrequent symptoms that require long-term monitoring or ongoing management. AccuRhythm™ AI algorithms are a groundbreaking platform that applies deep learning artificial intelligence algorithms to LINQ II™ data flowing into the CareLink™ network.

† Nominal settings.

AccuRhythm™ AI algorithms

Advanced algorithms enabling optimal outcomes

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

Clinically meaningful and actionable alerts

Developed over one million ECGs, the cloud-based Atrial Fibrilation and Pause AccuRhythm™ AI algorithms enhance the accuracy of LINQ II™ ICM data, reducing false alerts, while retaining true alerts, so you can maintain diagnostic yield and spend more time on the human side of care. 2-4

View AccuRhythm™ AI brochure
Graphic showing data flowing from the LINQ II™ ICM to a cloud representing AccuRhythm™ AI to the CareLink™ network

Reduce false alerts while maintaining sensitivity

AccuRhythm™ AI algorithms further address the two most common sources of these ICM false alerts — AF and Pause.2,3,5

Validation data from real-world LINQ II™ ICM patients demonstrated:

  • 97.4% reduction in false Pause alerts. 
  • 88.2% reduction in false AF alerts.

Preserved true alerts2:

  • 99% true AF alerts preserved
  • 100% true Pause alerts preserved
91% reduction in LINQ II™ ICM false alerts.

Reduce false alerts2,3

Chart showing data for false Pause and AF alert reduction with the LINQ II™ ICM

The AccuRhythmTM AI Algorithms can save clinicians approximately 200 hours of false alert review yearly for every 100 LINQ IITM ICM patients. ‡,§,2

View summary

‡ The validation study performance and time study results were projected onto 16,301 LINQ II™ patients to calculate the time saved per year in 100 LINQ II™ ICM patients.

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

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Remote programming

First ICM with remote programming◊,1

LINQ II ICM enables remote programming capability for all device parameters post-insertion from the clinic, which saves 211 hours per year by reducing alerts and patient face-to-face follow-ups.9

LINQII Carelink Network
Clinician initiates reprogramming via CareLink™ network.
LINQII monitor
Monitors act as a pass-through.
LINQ II Connect
Device settings are
automatically updated
without the need for
an office visit.

◊ First European-approved (TÜV-notified body) remote programmable device.

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Innovative PVC algorithm

PVC algorithm

The innovative PVC detector may help identify high-risk patients.7,8

Enlarge chart

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Seamless experience and connectivity

Increased connectivity. Seamless experience.

BlueSync™ technology within LINQ II™ ICM enables secure, wireless communication via Bluetooth®* Low Energy without compromising device longevity.1

  1. Reveal LINQ™ mobile manager
  2. LINQ II™ device
  3. MyCareLink Heart™ mobile app on patient’s smartphone or tablet, or
  4. MyCareLink Relay™ home communicator for bedside use
  5. CareLink™ network
  6. BeConnected Patient Service
  7. FocusOn™ Monitoring & Triaging Service
AI Image 1
AI Image 2

Effortless connectivity

  • Portable Bluetooth®* monitoring
  • Monitor automatically detects if new data is available
  • Event notification triggers an actionable alert

No manual transmissions

  • Remote access to full ECGs eliminates the need for manual transmissions1
  • Decreases patient action and confusion

Enhanced patient compliance

  • Automatic smartphone notifications help patients stay connected
  • Reduces clinic time spent on patient follow-up

MRI conditions for use

LINQ II™ insertable cardiac monitor (ICM) system

Conditionally safe MRI access SureScan™ technology
LINQ II™ ICM is MR Conditional at ≤ 3 T with no post-insertion waiting required.

Healthcare professional smiling down at patient who is entering an MRI scanner surrounded by abstract blue dots and particles

Watch this video to learn more about LINQ II™ ICM.  

Watch a real-life
LINQ IITM and remote monitoring story

Educational resources on Medtronic Academy
Find out more about the LINQ system

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*® Third-party brands are trademarks of their respective owners.

† Nominal settings.

‡ The validation study performance and time study results were projected onto 16,301 LINQ II™ patients to calculate the time saved per year in 200 LINQ II™ ICM patients.

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

◊ First European-approved (TÜV-notified body) remote programmable device.

1. LINQ II™ LNQ22 ICM clinician manual.

2. Radtke A, Hall M. AccuRhythm™ AI AF & Pause algorithms [white paper]. April 2023. Medtronic data on file.

3. Cheng YJ, Ousdigian KT, Koehler J, Cho YK, Kloosterman M. Innovative artificial intelligence application reduces false Pause alerts while maintaining perfect true Pause sensitivity for insertable cardiac monitors. Presented at HRS 2021.

4. AccuRhythm™ AI clinical manual supplements.

5. Radtke AP, Ousdigian KT, Haddad TD, Koehler JL, Colombowala IK. Artificial intelligence enables dramatic reduction of false atrial fibrillation alerts from insertable cardiac monitors. Heart Rhythm. 2021;18(S8):S47. Presented at HRS 2021.

6. Seiler A, Biundo E. Di Bacco M, 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. doi: 10.2196/27720.

7. Penela D, Fernández-Armenta J, Aguinaga L, et al. Clinical recognition of pure premature ventricular complex-induced cardiomyopathy at presentation. Heart Rhythm. 2017;14(12):1864–1870. doi: 10.1016/j.hrthm.2017.07.025.

8. Penela D, Van Huls Van Taxis C, Aguinaga L, et al. Neurohormonal, structural, and functional recovery pattern after premature ventricular complex ablation is independent of structural heart disease status in patients with depressed left ventricular ejection fraction: a prospective multicenter study. J Am Coll Cardiol. 2013;62(13):1195–1202. doi: 10.1016/j.jacc.2013.06.012.

9. Seiler A., et al. Utilization of Remote Reprogramming to Manage Insertable Cardiac Monitor Arrhythmia Alert Burden. J Cardiovasc Electrophysiol, 2024.

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