Device Dossier

SenSight™ Depth Stop and Cranial Tunneller Kit -Model B31010 - Surgical procedure kit, neurosurgical, single-use, non-medicated

Device Dossier for SenSight™ Depth Stop and Cranial Tunneller Kit -Model B31010 - Surgical procedure kit, neurosurgical, single-use, non-medicated…

Intended purpose

The Medtronic Model B31010 SenSight™ Depth Stop and Cranial Tunneler kit are components used during a lead implant procedure for a deep brain stimulation (DBS) system. The Depth Stop is an external device intended to retain the DBS lead position during implant. The Cranial Tunneler is a device intended to create a subcutaneous path for tunneling the DBS lead to the intended location during implant.

Functional description

The SenSight Depth Stop and Cranial Tunneler Kit includes components which can be used during delivery and implantation of the SenSight directional lead. The Depth Stop is an external device intended to retain the lead position during implant. The Cranial Tunneler, which is an assembly of a Tunneling Rod, a Sharp Tip, and a Passing Tube, is intended to create a subcutaneous path for tunneling the proximal end of the lead to the intended location during implant.

TGA Public Summary