Device Dossier

Senza II IPG Kit- Analgesic spinal cord electrical stimulation system pulse generator implantable

Device Dossier for Senza II IPG Kit- Analgesic spinal cord electrical stimulation system pulse generator implantable (Analgesic spinal cord electrical…

Intended purpose

The Senza neuromodulation systems are intended to aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain, upper back pain and leg pain.

Functional description

The Implantable Pulse Generator (IPG) is a rechargeable implantable device capable of stimulating the spinal cord nerves through the electrodes of the leads connected to any combination of the output terminals, using one programmable current source. The kit includes an IPG, a torque wrench, and 2 port plugs.

TGA Public Summary