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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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