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Important Safety Information

Important safety information
LINQ family of insertable cardiac monitors (ICMs) systems and accessories

The Reveal LINQ™ ICM is an insertable automatically-activated and patient-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

This device has not been tested specifically for pediatric use.

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

Possible risks associated with the implant of a LINQ Family ICM (LINQ II ICM or Reveal LINQ ICM) include, but are not limited to, infection at the surgical site, device migration, erosion of the device through the skin and/or sensitivity to the device material. Accessories available for use with LINQ Family ICMs may experience connectivity or performance issues. See product manuals for details and troubleshooting instructions.

LINQ Family ICMs are prescribed by your physician and are not for everyone. Please talk to your doctor to see if it is right for you. Your physician should discuss all potential benefits and risks with you. Although many patients benefit from the use of this product, results may vary. For further information, please call the Medtronic toll-free number at 1-800-551-5544 (7:00 a.m. to 7:00 p.m., Monday-Friday, Central Time) or see the Medtronic website at www.medtronic.com.

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Managing heart conditions

The link between heart health and stroke

Woman wearing a red shirt with her hands together in a yoga pose and smiling

Atrial fibrillation and stroke

Atrial fibrillation, or AFib, is a heart problem many people experience without knowing. It can happen rarely and without symptoms, and it can increase the risk of stroke.

Patients with AFib are 5x more likely to have a stroke.1

AFib-related stroke is twice as likely to be fatal than non-AFib-related stroke.2

Most AFib episodes are asymptomatic, meaning you don't feel them.3

If you’ve had a stroke, understanding your heart health is important to prevent your risk of having another one.

One in four stroke survivors will experience another stroke within five years.4

Stroke survivors are at high risk of AFib after their stroke.3,5

AFib is treatable, and treating AFib can lower your risk of another stroke.6

An insertable heart monitor can help.

Advanced solutions, such as long-term heart monitoring, are available for continuous monitoring after a cryptogenic stroke, large-vessel stroke, or small-vessel stroke. The automatic detection in the monitor can catch abnormal heart rhythms as they happen and send that information directly to your doctor. Information sent from an implanted heart monitor can help your doctor determine if you have AFib, or other possible underlying conditions.

Getting a heart monitor

References

1

Preventing Another Stroke. American Stroke Association. Available at: https://www.stroke.org/en/life-after-stroke/preventing-another-stroke. Accessed September 13, 2022.

2

Lin HJ, Wolf PA, Kelly-Hayes M, et al. Stroke severity in atrial fibrillation. The Framingham Study. Stroke. October 1996;27(10):1760-1764.

3

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

4

Mohan KM, Wolfe CD, Rudd AG, et al. Risk and cumulative risk of stroke recurrence: a systematic review and meta-analysis. Stroke. May 2011;42(5):1489-1494.

5

Bernstein RA, Kamel H, Granger CB, et al; for the STROKE-AF Investigators. Effect of Long-term Continuous Cardiac Monitoring vs Usual Care on Detection of Atrial Fibrillation in Patients With Stroke Attributed to Large- or Small-Vessel Disease. JAMA. June 1, 2021;325(21):2169-2177.

6

Stroke Prevention in Atrial Fibrillation Study. Final results. Circulation. August 1991;84(2):527-539.