Device Dossier

ReActiv8 Magnet - Implantable stimulator control magnet

Device Dossier for ReActiv8 Magnet - Implantable stimulator control magnet (Implantable stimulator control magnet, Class III, sponsor Mainstay Medical).…

Intended purpose

The patient magnet is used to turn an implanted pulse generator (IPG) (Reactiv8) on and off. 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 magnet that when held in close proximety to an implanted pulse generate is used to stop an active therapy session.

TGA Public Summary