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Description; Percutaneous Leads; Trial Leads; Lead Extension - Boston Scientific SC-2016 Série Mode D'emploi

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Description

Description
Leads function as a component of Boston Scientific's Precision™, Precision with MultiWave Technology,
Precision Novi™, and Precision Spectra™ Spinal Cord Stimulation (SCS) systems by delivering electrical
stimulation to the nerve structures in the dorsal aspect of the spinal cord, resulting in an inhibition of pain
sensation.

Percutaneous Leads

The eight-contact percutaneous leads are available in lengths of 30 cm, 50 cm, and 70 cm. Each Linear
lead has eight electrode contacts located near the distal end. Each contact is 3 mm in length and is
spaced 1, 4 or 6 mm from the adjacent contact.

Trial Leads

The Trial Lead Kit, containing the Linear Lead and the associated components, is intended to be used for
the temporary trial phase.

Lead Extension

Lead Extensions are designed to connect the percutaneous leads to the Precision, Precision with
MultiWave Technology, Precision Novi, or Precision Spectra IPG for spinal cord stimulation. The extension
may be added to a lead to externalize the lead for a trial procedure or to extend the lead when a
permanent IPG is implanted.
Lead extensions are available in lengths of 25 cm, 35 cm, and 55 cm. Each extension has eight electrode
contacts located near the distal end. Each contact is 3mm in length and is spaced 1 mm from the adjacent
contact. The extension can be connected to either the Trial Stimulator (via an OR Cable Assembly
included in the leads kit) or directly to the IPG.

Infinion Lead

The Infinion 16 percutaneous lead is available in lengths of 50 cm and 70 cm. Each lead has 16 contacts
located near the distal end. The Infinion lead can be connected directly to a 1x16 OR Cable when using
the Precision Spectra Trial Stimulator. When connecting to an IPG or a 1x8 or 2x8 OR Cable, a single
Infinion 16 lead must be inserted into a Splitter 2x8, which then connects to the IPG's 8 contact ports or
the 1x8 or 2x8 OR Cable.

Lead Splitters

The 2x4 Lead Splitters are designed to connect multiple percutaneous leads to the Precision, Precision
with MultiWave Technology, Precision Novi, or Precision Spectra IPG. The Linear leads may be inserted
into a splitter for a maximum of four Linear leads per Precision, Precision with MultiWave Technology, and
Precision Novi IPGs or a maximum of eight leads per Precision Spectra IPG. Four of the eight contacts of
each Linear lead will be activated. Two configurations of Splitter 2x4 are available: Distal 4 (D4) and Wide 4
(W4). The two versions offer different contact configurations.
The Lead Splitter 2x8 is required to connect the Infinion 16 contact lead to the IPG. Each Infinion 1x16
lead requires a Splitter 2x8 to be used with two IPG ports.
Percutaneous Leads Directions for Use
90970887-03 Rev A
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