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The Transoma Medical Sleuth Implantable ECG Monitoring System is an implantable, patient- and automatically-activated monitoring system that records subcutaneous ECG and is indicated for: - patients with clinical syndromes or situations at increased risk of cardiac arrhythmias or . - patients who experience transient symptoms that may suggest a cardiac arrhythmia.

The Transoma Medical Sleuth Implantable ECG Monitoring System is designed to measure and store the patient s electrocardiogram (ECG) during symptomatic and asymptomatic events. The Sleuth System consists of the Model 2010 Implantable Monitoring Device (IMD), the Model 4000 Activator, and the Model 5000 Base Station (Bluetooth Modem). The IMD is an anatomically-shaped Litanium structure which is implanted subcutancously, typically in the left pectoral region. The Activator is a hand-held device carried by the patient. The IMD continuously measures the R-R interval and automatically stores ECG segments when this interval falls outside of pre-defined limits. Using the Activator, the patient can also request storage of ECG segments when symptoms are experienced. The IMD stores a limited quantity of events, which are · ansferred to the Activator via telemetry throughout the day. On a daily basis, the Activator transfers events through the Base Station to a service center for review and analysis.