Intracardiac pacemaker programming interface unit

Definition

An external, electronic device intended to interface a dedicated patient lead (cable with skin surface electrodes) with a pacemaker programmer (from which it draws its power), to enable noninvasive interrogation and programming of an implanted intracardiac pacemaker using high frequency electrical pulses (as an alternative to wireless communication); it is also intended to collect electrocardiogram (ECG) data for observation of pacemaker function. Pacemaker communication and ECG data collection is achieved via the patient cable/electrodes which are typically included. The device is intended to be used by a healthcare professional in a clinical setting.

GUDID devices

1

Last updated

2023-03-13 08:40:58