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    • Atrial fibrillation (AF) management

    Learn more about how our portfolio can help you detect, reduce, and respond to atrial fibrillation (AF), and treat paroxysmal AF in your patients.

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    Bradyarrhythmia management

    Gain a better understanding of bradyarrhythmia management for your patients.

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    Cardiac ablation and mapping

    Discover cardiac ablation and mapping solutions for atrial fibrillation from Medtronic.

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    Cardiac diagnostics and monitoring

    Explore indications, clinical evidence, and resources for the LINQ™ family of insertable cardiac monitors (ICMs).

    To view the indications, safety, and warnings, scroll down or click on one of the links below to jump you down the page to that product.

    LINQ II™ ICM ISW

    Brief statement for LINQ II™ insertable cardiac monitor system (ICM) and accessories

    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 two 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.

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

    Potential adverse events or potential complications

    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 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) or 800-551-5544 (patient services).

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

    MAJ_90968

    Reveal LINQ™ ICM ISW

    Brief statement for Reveal LINQ™ insertable cardiac monitor (ICM) system and accessories

    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.

    Contraindications

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

    Warnings and 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. 

    Accessories available for use with Reveal LINQ™ ICM may experience connectivity or performance issues. See product manuals for details and troubleshooting instructions.

    Potential adverse events or 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.  

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

    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 (Technical Services) or (800) 551-5544 (Patient Services).

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

    MAJ_90968

    AccuRhythm™ AI Algorithms ISW

    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, 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.

    MAJ_84705

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