Important Safety Information

Additional Device Information
REVEAL LINQ™ 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 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

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 CareLink Patient Services at 1 (800) 929-4043 (8:00 a.m. to 5:00 p.m., Monday-Friday, Central Time) or see the Medtronic website at www.medtronic.com

Medtronic SEEQ™ Mobile Cardiac Telemetry (MCT) System

Indications
The Medtronic SEEQ™ Mobile Cardiac Telemetry (MCT) System is intended to continuously measure, record and periodically transmit physiological data. The System is indicated for those patients who require monitoring for the detection of non-lethal cardiac arrhythmias such as, but not limited to supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, paroxysmal SVTs), ventricular ectopy, bradyarrhythmias and conduction disorders. The SEEQ™ MCT System monitors, derives and displays: ECG, Heart Rate.

Contraindications

  • Patients with known allergies or hypersensitivities to adhesives or hydrogel
  • Patients with potentially life-threatening arrhythmias, or who require inpatient / hospital monitoring

Warnings and Precautions

  • Do not reapply Wearable Sensor (it is meant for one-time use)
  • For a complete list of precautions, please refer to the Instructions for Use document

See the device manual for detailed information regarding the indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic's website at www.medtronic.com.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.

The SEEQ™ MCT System and the Medtronic Monitoring Center are provided by Medtronic Monitoring Inc., a wholly owned subsidiary of Medtronic.