Indications, Safety, and Warnings
Indications
The Reveal LINQ™ insertable cardiac monitor (ICM) 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.
Reveal LINQ™ mobile manager system
The Reveal LINQ™ mobile manager app is intended for programming and interrogating the Reveal LINQ™ ICM LNQ11. The Medtronic patient connector is a portable electronic device using low frequency inductive telemetry to communicate with the Reveal LINQ™ ICM. The patient connector uses Bluetooth® technology to transmit implantable heart device data to the Reveal LINQ™ mobile manager app for further processing. The patient connector is intended to be used by healthcare personnel only in a clinical or hospital environment.
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.
Contraindications
There are no known contraindications for the implant of the Reveal LINQ™ ICM or for the Reveal LINQ™ mobile manager system. However, the patient’s particular medical condition may dictate whether or not a subcutaneous, chronically implanted device can be tolerated.
Reveal LINQ Insertable Cardiac Monitor
Warnings/precautions
Patients with the Reveal LINQ™ ICM 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.
Reveal LINQ™ mobile manager system
Before inserting the Reveal LINQ™ ICM, verify that the patient connector and mobile device are fully charged. The patient connector and mobile device may run out of power during the insertion procedure if they are not fully charged. You will not be able to program or interrogate the patient’s Reveal LINQ™ ICM until the patient connector and the mobile device have power.
Only use the patient connector to communicate with the intended implanted device. Do not use the patient connector to communicate with other implanted devices. Using the patient connector to communicate with other implanted devices can interfere with those devices, potentially affecting the other implanted device’s functionality or therapy delivery.
Use of wireless devices
The patient connector incorporates radiofrequency (RF) communications components which may affect other devices and equipment in the medical environment. The use of wireless devices in the medical environment must be evaluated and authorized by the responsible organization. RF interference may affect device performance. Electromagnetic compliance (EMC) testing shows that the patient connector provides reasonable protection against harmful interference and provides EMC immunity in a typical medical installation. The use of wireless devices in the medical environment must be evaluated and authorized by the responsible organization. However, there is no guarantee that interference will not occur in a particular installation. If the patient connector does cause harmful interference to other devices or is negatively impacted by other devices, correct the interference by one or more of the following measures: reorient or relocate the patient connector and other devices; increase the separation between the patient connector and other devices by at least two meters (approximately 6 feet); and/ or turn off any interfering equipment.
Radiofrequency (RF) interference
Portable and mobile RF communications equipment can interfere with the operation of the patient connector. There is no guarantee that it will not receive interference or that any particular transmission from this system will be free from interference. To avoid interference, do not use the patient connector and mobile device within 2 m (6 feet) of other wireless communications equipment. Using the patient connector near these devices could interfere with communication between the Reveal LINQ™ ICM and the patient connector.
Security
Maintain adequate physical security of the patient connector to prevent unauthorized use that could lead to harm to patients. Bluetooth® communication in the patient connector is encrypted for security. Medtronic inductive telemetry uses short-range communication to protect patient information. If the patient connector should fail, there is no risk of patient harm.
Environmental precautions
To ensure safe and effective operation, use the device with care to avoid damage to the patient connector from environmental factors that may impair its function. Care is exercised in design and manufacturing to minimize damage to devices under normal use. However, electronic devices are susceptible to many environmental stresses. Specifically, the patient connector may be affected by electrostatic discharge (ESD). In an environment likely to cause ESD, such as a carpeted floor, discharge any charge collected on your body before touching the device.
Patient assistant
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
Potential complications of the Reveal LINQ™ device include, but are not limited to, device rejection phenomena (including local tissue reaction), device migration, infection, and erosion through the skin.
See the device manuals 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.
Caution: Federal law (United States) restricts these devices to sale by or on the order of a physician.
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LINQ II™ insertable cardiac monitor
Reveal LINQ™ insertable cardiac monitor