ReActiv8 Application Software - Implantable electrical stimulation device management software

Intended purpose

A software program intended to assist with the management of a ReActiv8 Implantable Pulse Generator. The Application Software provides a user interface that is used to program the IPG (change the value of the programmable parameters), interrogate the IPG (ask for the actual value of the programmable parameters, battery voltage, logged information and IPG status) and read the lead impedance (command the IPG to perform the procedure that allows it to calculate the lead impedance). The ReActiv8 System is indicated for bilateral stimulation of the L2 medial branch of the dorsal ramus as it crosses the L3 transverse process as an aid in the management of intractable chronic low back pain associated with multifidus muscle dysfunction, as evidenced by imaging and associated physiological presentation.

Functional description

A software program that is installed on a compatible computer used to program the ReActiv8 implantable neurostimulator system. The software interrogates the ReActiv8 system, permits the download of historical data, permits the analysis of that data, permits the testing of stimulator settings and impedance, and permits the programming of final device settings for home use of the neurostimulator.