Device Dossier

S8 Lead Adaptor Kit - Electrode/lead, stimulator, implantable, neurological

Device Dossier for S8 Lead Adaptor Kit - Electrode/lead, stimulator, implantable, neurological (Neural-tissue electrical stimulation lead, Class III,…

Intended purpose

The S8 Lead Adaptor is intended to be used when an implantable pulse generator (IPG) from St. Jude Medical is replaced with a new Nevro Senza IPG. The S8 Lead Adaptor is designed to link compatible St. Jude Medical’s leads to a Nevro IPG.

Functional description

The S8 Lead Adaptor will be chronically implanted. One end will be connected to the St Jude Medical 8-contact lead / Lead extension and the other will be connected to the Nevro IPG / Lead extension. The entire length of the Lead Adaptor remains subcutaneous. The Lead adaptor kit contains the adaptor and torque wrench which is used to tighten the set screws on the lead extender and on the IPG.

TGA Public Summary