Device Dossier

Senza Bluetooth Trial Stimulator Kit (EXTS3000) - Analgesic spinal cord electrical stimulation system pulse generator

Device Dossier for Senza Bluetooth Trial Stimulator Kit (EXTS3000) - Analgesic spinal cord electrical stimulation system pulse generator (Analgesic…

Intended purpose

The Trial simulator kit is an externally worn SCS device that delivers therapy, stops delivering therapy, increases or decreases therapy intensity, or changes therapy types (“programs”) in response to commands that you send it using the Remote Control. The Trial Stimulator kit is a component of the Senza® Bluetooth® Trial System. The Senza® Bluetooth® Trial System 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: o Failed back surgery syndrome o Intractable low back pain o Upper back pain o Leg pain o Upper limb and neck pain

Functional description

The Trial Stimulator is an externally worn SCS device that delivers therapy, stops delivering therapy, increases or decreases therapy intensity, or changes therapy types (“programs”) in response to commands that you send it using the Remote Control.

TGA Public Summary