INDICATIONS, SAFETY, AND WARNINGS Reveal LINQ™ Insertable Cardiac Monitor with TruRhythm™ Detection
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:
This device has not specifically been tested for pediatric use.
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.
There are no known contraindications for the implant of the Reveal LINQ Insertable Cardiac Monitor. However, the patient's particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated.
Patients with the Reveal LINQ Insertable Cardiac Monitor 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.
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.
Potential complications include, but are not limited to, device rejection phenomena (including local tissue reaction), device migration, infection, and erosion through the skin.
The Medtronic MyCareLink™ Patient Monitor and CareLink™ Network are 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 CareLink™ Mobile Application is intended to provide current CareLink Network customers access to CareLink Network data via a mobile device for their convenience. The CareLink Mobile Application is not replacing the full workstation, but can be used to review patient data when a physician does not have access to a workstation. These products are not a substitute for appropriate medical attention in the event of an emergency and should only be used as directed by a physician. CareLink Network availability and mobile device accessibility may be unavailable at times due to maintenance or updates, or due to coverage being unavailable in your area. Mobile device access to the Internet is required and subject to coverage availability. Standard text message rates apply.
There are no known contraindications.
The MyCareLink Patient Monitor must only be used for interrogating compatible Medtronic implantable devices.
See the device manual for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult the Medtronic website at www.medtronic.com.
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.