Device Dossier

Senza Omnia IPG Kit - NIPG2500 - Stimulator, electrical, analgesic, spinal cord

Device Dossier for Senza Omnia IPG Kit - NIPG2500 - Stimulator, electrical, analgesic, spinal cord (Stimulator, electrical, analgesic, spinal cord, AIMD,…

Intended purpose

The Senza Omnia IPG kit is a component of the Senza Omnia neuromodulation system, which is indicated as an 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 IPG is a rechargeable implantable device with 16 output channels capable of stimulating the spinal cord nerves through electrode leads. The IPG is designed to produce current-regulated, charge-balanced, biphasic, capacitively-coupled, rectangular output pulses. The IPG Header contains the charging coil and two ports to allow the insertion of leads. The rechargeable battery is contained inside the IPG titanium enclosure. The kit contains IPG, torque wrench, and two port plugs.

TGA Public Summary