Your browser is out of date

With an updated browser, you will have a better Medtronic web site experience. Update my browser now.

×

Indications, Safety, & Warnings

Indications, safety, and warnings
Cardiac diagnostics and monitoring systems

Quick links to sections:

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.

MAJ_72929

Menu
United States of America
United States of America
Contact & Support

LINQ II™ Insertable Cardiac Monitor

Find answers for your younger patients.†

The LINQ II insertable cardiac monitor (ICM) is now available for pediatric patients two years and older.

Alert Indications, Safety, and Warnings

Why the LINQ II ICM for pediatric patients?

Medtronic remains committed to expanding patient access for insertable cardiac monitors, and is excited to announce that the LINQ II ICM is now available for patients as young as two years old. Insertion of a LINQ II ICM typically takes less than five minutes. It involves making a small < 1 cm incision with a preloaded insertion tool.

If you would like to learn more about the LINQ II ICM and the insertion procedure, please complete this short form to be contacted by a Medtronic representative.

Request a demo

† Indicated for patients two years and older.

Young girl in pink in doctor's office sitting on a table smiling and talking to the pediatrician

Cardiac monitoring for pediatric patients.

Trust the most accurate ICM1–13 on the market for your pediatric patients.

The LINQ II ICM is one of the smallest14,15 insertable cardiac monitors, making it the optimal choice for pediatric patients who need cardiac monitoring. The device delivers 24/7 heart monitoring with no patches or wires in the way, letting kids be kids and granting peace of mind for parents and caregivers. The LINQ II ICM can help your pediatric patients enjoy a better quality of life and get back to their active lifestyle.

Insertable cardiac monitors are useful for monitoring arrhythmias in pediatric patients. As part of a retrospective study, it was reported ICM monitoring led to a change in management in one-third of patients.16

Learn more about the LINQ II ICM.

Find out more about the LINQ II ICM to better manage your younger patients who experience infrequent symptoms that require long-term monitoring or ongoing management.

Learn more

Stay connected.

Opt in to get the latest updates on ICM products, events, and training.

Email sign-up

Training and education

Visit Medtronic Academy to access a variety of training and education resources. Registration and/or login required.

Visit Medtronic Academy (opens new window)

Follow us on social media.

Stay up to date on product updates and events.

*

™Third-party brands are trademarks of their respective owners.

References

1

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.

2

Nölker G, Mayer J, Boldt L, 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.

3

Confirm Rx™* ICM K163407 FDA clearance letter. 2017.

4

Confirm Rx ICM K182981 FDA clearance letter. 2019.

5

Jot Dx™* ICM K212206 FDA clearance letter. 2021.

6

Monitoring Devices Merlin™* PCS Help Manual for SJM Confirm™*, Confirm Rx ICM, Jot Dx Manual. 2021.

7

BIOTRONIK BioMonitor™* 2 technical manual. 2017.

8

BIOTRONIK BIOMONITOR III technical manual. 2020.

9

BIOTRONIK BIOMONITOR IIIm technical manual. 2020.

10

BIOTRONIK BIOMONITOR III. K190548 FDA clearance. 2019.

11

BIOTRONIK BIOMONITOR IIIm. K201865 FDA clearance. 2020.

12

Lux-Dx™* ICM K212206 FDA clearance letter. 2020.

13

Lux-Dx ICM user manual. 2020.

14

LINQ II™ LNQ22 ICM clinician manual M032283C001.

15

Assert-IQ™ Model DM5000, DM5300, DM5500, Insertable Cardiac Monitor manual. 2023.

16

Utilization of remote reprogramming to manage insertable cardiac monitor arrhythmia alert burden. Medtronic data on file.

There are items that require your attention.
There are items that require your attention.
There are items that require your attention.
There are items that require your attention.
There are items that require your attention.

Your information will be used and protected in accordance with our {link}

There are items that require your attention.
United States

Customer Care Team

Hours: 8:00 a.m. - 8:00 p.m. EST 

 

Phone: 763-514-4000

Toll-free: 800-633-8766

There are items that require your attention.
There are items that require your attention.
There are items that require your attention.

Just to confirm, is this the product or product type that interests you?

{{productNamePlaceholder}}

OR

There are items that require your attention.

OR

There are items that require your attention.
There are items that require your attention.

OR

There are items that require your attention.
There are items that require your attention.
There are items that require your attention.
There are items that require your attention.

OR

There are items that require your attention.

Before we get started, what best describes you?

OR

There are items that require your attention.

OR

OR

There are items that require your attention.

Before we get started, what best describes you?

OR

There are items that require your attention.
There are items that require your attention.
There are items that require your attention.
There are items that require your attention.
There are items that require your attention.

Your personal data will be used to manage your relationship with Medtronic in accordance with our {link}

There are items that require your attention.

Before we get started, what best describes you?

OR

There are items that require your attention.
There are items that require your attention.
There are items that require your attention.
There are items that require your attention.
There are items that require your attention.
There are items that require your attention.

If you consent to receive emails, you can unsubscribe anytime via the link in each email. We use technology that measures email opens and clicks, to improve our communications and provide relevant content. For details, see our {link}