Device Dossier
M8 Lead Adaptor Kit - Electrode/lead, stimulator, implantable, neurological
Device Dossier for M8 Lead Adaptor Kit - Electrode/lead, stimulator, implantable, neurological (Neural-tissue electrical stimulation lead, Class III,…
- GMDN category: Neural-tissue electrical stimulation lead
Intended purpose
The M8 Lead Adaptor is intended to be used when an implantable pulse generator (IPG) from Medtronic is replaced with a new Nevro Senza IPG. The M8 Lead Adaptor is designed to link compatible Medtronic leads to a Nevro IPG.
Functional description
The M8 Lead Adaptor will be chronically implanted. One end will be connected to the Medtronic 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.