Patient Assistant for LINQ II ICM, PA97000 - Cardiac pulse generator reader, home-use

Intended purpose

The Patient Assistant model PA97000 initiates the recording of cardiac event data in the device memory of compatible Medtronic cardiac implantable electronic devices. The Patient Assistant is intended for unsupervised patient use away from a hospital or clinic.

Functional description

The Patient Assistant Model PA97000 is a hand-held, battery-operated (non-replaceable lithium ioncell battery) device that uses Bluetooth Low Energy (BLE). The Patient Assistant enables the patient to record cardiac information in the LINQ II ICM while experiencing or immediately after a symptomatic event. The clinician uses the recorded information to determine if the symptoms were associated with a cardiac event.