Instructions for Use
Percutaneous Leads Directions for Use
en
Infinion CX Lead Placement in the Epidural Space with Entrada™ Needle
Infinion CX Lead
The Infinion CX Lead has two tails to enable insertion into 8-contact IPG ports without the use of a
Splitter 2x8. The two tails will not fit through a standard 14 gauge insertion needle or Epimed needle,
therefore these needles are not compatible with the Infinion CX Lead.
Do not use a standard 14 gauge
introducer or Epimed needle to introduce the Infinion CX Lead.
Use only the Entrada Needle with peelable sheath to introduce the Infinion CX Lead into the epidural
space.
An anchor must be pre-loaded on the distal end of the Infinion CX Lead prior to inserting the lead into the
Entrada Needle. When using an anchor or suture sleeve with the Infinion CX Lead, the stylet may be in
place within the lead when the anchor is loaded on the lead. Ensure that stylet is removed from the lead
prior to securing the anchor.
Entrada™ Needle
The Entrada Needle with peelable sheath is required to insert the Infinion CX Lead into the epidural space.
The Entrada Needle may also be used with all percutaneous leads listed under “Product Model Numbers”
Fully Assembled Entrada Needle
5
Components
Components are marked with dots to indicate use order, and the dots should be in the same direction
when assembling the needle.
5
Needle Stylet, •
Loss of Resistance (LOR) adaptor, ••
Slotted Needle, •••
Peelable Sheath
