IMPORTANT SAFETY INFORMATION HEART MONITORS

Reveal LINQ ICM System and Reveal XT ICM

IMPORTANT SAFETY INFORMATION

Additional Device Information 

REVEAL LINQTM Insertable Cardiac Monitor

The Reveal LINQ Insertable Cardiac Monitor 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.

Possible risks associated with the implant of the Reveal LINQ Insertable Cardiac Monitor 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.

Treatment with a Reveal LINQ Insertable Cardiac Monitor is prescribed by your physician. This treatment is 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 treatment, results may vary. For further information, please call the Medtronic toll-free number at 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

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.

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.

Medtronic MyCareLink Patient Monitor

The Medtronic MyCareLink™ Patient Monitor is a prescription product 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 MyCareLink Patient Monitor transmissions to the CareLink™ Network are subject to cellular service availability. The MyCareLink Patient Monitor must be on and in range of the device in order to wirelessly receive data from your implanted device. This product is not a substitute for appropriate medical attention in the event of an emergency and should only be used as directed by a physician.

The Medtronic CareLink Service is prescribed by your physician. This service is 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 service, results may vary. For further information, please call the Medtronic toll-free number at 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

RevealTM XT Insertable Cardiac Monitor

The Reveal XT Insertable Cardiac Monitor 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.

Possible risks associated with the implant of a Reveal XT Insertable Cardiac Monitor 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.

Treatment with a Reveal XT Insertable Cardiac Monitor is prescribed by your physician. This treatment is 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 treatment, results may vary. For further information, please call the Medtronic toll-free number at 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