Device Dossier

D4 Splitter 2x4 - Electrode/lead, stimulator, implantable, neurological

Device Dossier for D4 Splitter 2x4 - Electrode/lead, stimulator, implantable, neurological (Neural-tissue electrical stimulation lead, Class III, sponsor…

Intended purpose

The Boston Scientific Distal 4 (D4) Splitter 2x4 is used with the Precision System as an aid in the management of chronic intractable pain. The Splitter 2x4 is an extension like adaptor used to connect multiple Linear leads to the Boston Scientific Implantable Pulse Generator (IPG).

Functional description

The proximal end of the Splitter has 8 ring contacts to form an electrical connection when inserted into the IPG. The distal end of the Splitter has 2 headers, each with 4 active contacts to form an electrical connection when a linear lead is inserted. 2 linear leads can be inserted to stimulate 2 different areas using 4 active contacts on each lead. On the D4 Splitter 4 of the 8 contacts (electrodes 1, 2, 3 & 4) of each Linear Lead are active providing a close contact spacing configuration.

TGA Public Summary