Device Dossier

LINQ II™ LNQ22 Insertable Cardiac Monitor - Implantable cardiac monitor

Device Dossier for LINQ II™ LNQ22 Insertable Cardiac Monitor - Implantable cardiac monitor (Implantable cardiac monitor, Class III, sponsor Medtronic).…

Intended purpose

The LINQ II ICM is a single-patient-use, minimally invasive, insertable, sterile device intended to provide continuous monitoring of ECG and other physiological parameters. The LINQ II ICM is an insertable 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 that may suggest a cardiac arrhythmia

Functional description

Medtronic LINQ II ICM is a programmable device that continuously monitors a patient’s ECG and other physiological parameters. The device records cardiac information in response to automatically detected arrhythmias and patient-initiated activation or markings. It is a small, leadless device that is inserted under the skin, in the chest. The device uses 2 electrodes on the body of the device to monitor the patient’s subcutaneous ECG continuously.

TGA Public Summary