Boston Scientific SC-2016 Series Manual

Percutaneous Leads
Directions for Use
92469115-02
Content: MP92469115-02 REV A
Directions for Use
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Percutaneous Leads Directions for Use
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Guarantees
Boston Scientic Corporation reserves the right to modify, without prior notice, information relating to its products in order to improve their reliability
or operating capacity.
Drawings are for illustration purposes only.
Trademarks
All trademarks are the property of their repective holders.
Additional Information
For Indications and related information, see the Indications DFU or Clinician Manual for your System. For contraindications, warnings, precautions,
adverse events summary, physician instructions, sterilization, component disposal, and contact information for Boston Scientic, refer to the
Information for Prescribers DFU or Clinician Manual for your System. For other device-specic information not included in this manual, labeling
symbols, and warranty, refer to the appropriate DFU as listed on your Reference Guide.
Product Model Numbers
Model Numbers Description
SC-2016-xx Innion™ 16 Lead and Splitter 2x8 Kit
SC-2016-xxE Innion 16 Lead and Splitter 2x8 Trial Kit
SC-2138-xx Linear™ xxcm 8 Contact Lead
SC-2158-xx Linear xxcm 8 Contact Lead
SC-2158-xxE Linear xxcm 8 Contact Trial Lead
SC-2208-xx Linear ST xxcm 8 Contact Lead
SC-2218-xx Linear ST xxcm 8 Contact Lead
SC-2218-xxE Linear ST xxcm 8 Contact Trial Lead
SC-2352-xx Linear 3-4 xxcm 8 Contact Lead
SC-2352-xxE Linear 3-4 xxcm 8 Contact Trial Lead
SC-2366-xx Linear 3-6 xxcm 8 Contact Lead
SC-2366-xxE Linear 3-6 xxcm 8 Contact Trial Lead
SC-3138-xx xxcm 8 Contact Extension
SC-3304-xx D4 Splitter 2x4
SC-3354-xx W4 Splitter 2x4
SC-2316-xx Innion 16 xxcm 16 Contact Lead Kit
SC-2316-xxE Innion 16 xxcm 16 Contact Trial Lead Kit
SC-3400-xx xxcm Splitter 2x8 Kit
SC-2317-xx Innion CX xxcm 16 Contact Lead Kit
SC-2317-xxE Innion CX xxcm 16 Contact Trial Lead Kit
Note: xx = length (cm), xxE = length (cm) Trial Lead

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Description........................................................................................................................................................................... 1
Percutaneous Leads...........................................................................................................................................................1
Trial Leads ..........................................................................................................................................................................1
Lead Extension...................................................................................................................................................................1
Innion 16 Lead ..................................................................................................................................................................1
Innion CX Lead .................................................................................................................................................................1
Lead Splitters......................................................................................................................................................................1
Package Contents ............................................................................................................................................................... 2
Specications and Technical Data..................................................................................................................................... 3
Registering the Leads......................................................................................................................................................... 4
Instructions for Use............................................................................................................................................................. 4
Lead, Lead Extension, and Splitter Handling and Storage.................................................................................................4
Innion CX Lead .................................................................................................................................................................4
Entrada™ Needle ...............................................................................................................................................................4
Fully Assembled Entrada Needle ................................................................................................................................. 4
Components ................................................................................................................................................................. 5
Assembling and Reassembling the Entrada Needle .................................................................................................... 5
Lead Placement for Spinal Cord Stimulation (SCS) ...........................................................................................................5
Innion CX Lead Placement for SCS Using the Entrada Needle .......................................................................................6
Peripheral Nerve Stimulation (PNS) ...................................................................................................................................8
Lead Placement for PNS ....................................................................................................................................................8
Innion CX Lead Placement with Entrada™ Needle for PNS.............................................................................................8
Lead Connection to Splitter ................................................................................................................................................9
Intraoperative Stimulation Testing.....................................................................................................................................10
Securing the Trial Lead.....................................................................................................................................................11
Securing the Trial Innion CX Lead ..................................................................................................................................11
Permanent Lead Anchoring and Tunneling.......................................................................................................................11
Removing the Insertion Needle .................................................................................................................................. 11
Removing the Entrada Needle.................................................................................................................................... 12
Anchoring the Lead for SCS ....................................................................................................................................... 12
Anchoring the Lead for PNS ....................................................................................................................................... 13
Tunneling the Lead or Lead Extension ....................................................................................................................... 13
Connecting the Lead Extension........................................................................................................................................14
Lead/Extension/Splitter Removal......................................................................................................................................15
Option A: Lead Removal after Temporary Trial .......................................................................................................... 15
Option B: Lead Extension Removal After Permanent Trial ......................................................................................... 15
Option C: Splitter Removal ......................................................................................................................................... 16
Option D: Permanent Lead Removal for PNS ............................................................................................................ 16
Programming with the Innion 16 Lead and Innion CX Lead ..................................................................................... 16
Table of Contents

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Description
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Description
Leads function as a component of the Boston Scientic Systems by delivering electrical stimulation to nerve structures in the dorsal aspect of the
spinal cord and to peripheral nerves of the trunk, resulting in an inhibition of pain sensation.
The Entrada™ Needle (Model SC-4220-XX) functions as a component of the Boston Scientic Systems.
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 Implantable Pulse Generator (IPG) for 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.
Innion 16 Lead
The Innion 16 percutaneous Lead is available in lengths of 50 cm and 70 cm. Each Lead has 16 contacts located near the distal end. The Innion
16 Lead can be connected directly to a 1x16 OR Cable when using the External Trial Stimulator. When connecting to an IPG or a 1x8 or 2x8 OR
Cable, a single Innion 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.
Innion CX Lead
The Innion CX percutaneous Lead is available in lengths of 50 cm and 70 cm. Each Lead has 16 contacts located near the distal end and two tails
with 8 proximal contacts. The Innion CX Lead can be connected directly to a 2x8 OR Cable when using the External Trial Stimulator. The Innion
CX Lead may be connected directly to the IPG’s 8 contact ports.
Lead Splitters
The 2x4 Lead Splitters are designed to connect multiple percutaneous Leads to the IPG. The Linear Leads may be inserted into a Splitter for a
maximum of four Linear Leads per 2-port IPG or a maximum of eight Leads per 4-port IPG IPG. Four of the eight contacts of each Linear Lead will be
activated. Two congurations of Splitter 2x4 are available: Distal 4 (D4) and Wide 4 (W4). The two versions offer different contact congurations.
The Lead Splitter 2x8 is required to connect the Innion 16 contact Lead to the IPG. Each Innion 1x16 Lead requires a Splitter 2x8 to be used with
two IPG ports.

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Package Contents
Percutaneous Permanent Lead Kits
(1) Percutaneous Lead with pre-loaded Curved Stylet
(1) Stylet Ring with a Curved and a Straight Stylet
(4) Suture Sleeves
(1) Insertion Needle with Stylet
(1) Lead Blank
(1) Steering Cap
(1) OR Cable Assembly
(2) Lead Position Labels—left and right (non-sterile)
Percutaneous Trial Lead Kit
(1) Percutaneous Lead with pre-loaded Curved Stylet
(1) Suture Sleeve
(1) Insertion Needle with Stylet
(1) Steering Cap
(1) OR Cable Assembly
(2) Lead Position Labels—left and right (non-sterile)
Lead Extension Kit
(1) Lead Extension
(1) Hex Wrench
(1) Tunneling Tool Assembly
2x4 Splitter Kit
(1) Splitter
(1) Hex wrench
Splitter 2x8 Kit
(1) Splitter 2x8
(1) Torque Wrench
Innion 16 Lead Kit
(1) 16 Contact Lead with pre-loaded Curved Stylet
(1) Stylet Ring with a Curved and a Straight Stylet
(1) Straight Stylet
(4) Suture Sleeves
(1) Insertion Needle
(1) Lead blank
(1) Steering Cap
(2) Lead Position Labels—left and right (non-sterile)
Innion 16 Trial Lead Kit
(1) 16 Contact Percutaneous Lead with pre-loaded Curved Stylet
(1) Suture Sleeve
(1) Insertion Needle
(1) Steering Cap
(2) Lead Position Labels—left and right (non-sterile)
Innion 16 Trial Conguration Kit
(1) Innion 16 Trial Lead Kit
(1) 2x8 Splitter Kit
Innion 16 Conguration Kit
(1) Innion 16 Lead Kit
(1) 2x8 Splitter Kit
Innion CX Lead Kit
(1) 16 Contact Percutaneous Innion CX Lead with pre-loaded Curved Stylet
(2) Suture Sleeves
(2) Lead Position Labels—left and right (non-sterile)
(1) Steering Cap
Innion CX Trial Lead Kit
(1) 16 Contact Percutaneous Innion CX Lead with pre-loaded Curved Stylet
(2) Suture Sleeves
(2) Lead Position Labels—left and right (non-sterile)
(1) Steering Cap

Specications and Technical Data
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Specications and Technical Data
Linear Lead
Part Specications
Lead Lengths 30, 50, 70 cm
Lead shape In-line
Lead Diameter 1.3 mm
Number of Electrode Contacts 8
Electrode Length 3 mm
Electrode Spacing 1, 4, or 6 mm
Contact Material Platinum/Iridium
Insulation Material Polyurethane
Conductor Material MP35N-DFT-28% Ag
Innion 16 Lead
Part Specications
Lead Lengths 50, 70 cm
Lead shape In-line
Lead Diameter 1.3 mm
Number of Contacts 16
Contact Length 3 mm
Contact Spacing 1 mm
Contact Material Platinum/Iridium
Insulation Material Polyurethane
Conductor Material 35N LT-DFT-28% Ag
Innion CX Lead
Part Specications
Lead Lengths 50, 70 cm
Lead shape In-line
Lead Diameter 1.3 mm (each segment)
Number of Contacts 16
Contact Length 3 mm
Contact Spacing 1 mm
Contact Material Platinum/Iridium
Insulation Material Polyurethane
Conductor Material 35N LT-DFT-28% Ag
Lead Extension
Part Specications
Extension Lengths 25, 35, 55 cm
Extension Diameter 1.3 mm
Number of Electrode Contacts 8
Contact Material Platinum/Iridium, Stainless Steel
Insulation Material Silicone, Polyurethane
Conductor Material MP35N-DFT-28% Ag
2x4 Splitter
Part Specications
Splitter Length 25 cm
Splitter Diameter 1.3 mm (each segment)
Number of Electrode Contacts 8 (4 per receptacle)
Contact Material Platinum/Iridium, Stainless Steel
Insulation Material Silicone, Polyurethane
Conductor Material MP35N-DFT-28% Ag
Splitter 2x8
Part Specications
Splitter Length 30 cm
Splitter Diameter 1.3 mm (each segment)
Number of Electrode Contacts 16 (8 per tail)
Contact Material Platinum/Iridium, Stainless Steel
Insulation Material Silicone, Polyurethane
Conductor Material MP35N-DFT-28% Ag

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Registering the Leads
In accordance with international practice and regulatory legislation in some countries, a registration form is packed with each Boston Scientic Lead/
Lead extension/Splitter.
The purpose of this form is to maintain traceability of all products and to secure warranty rights. It also allows the institution involved in the evaluation
or replacement of a specic implanted Lead, accessory or device to gain quick access to pertinent data from the manufacturer.
Fill out the registration form included in the package contents. Return one copy to Boston Scientic, keep one copy for patient records, provide one
copy to the patient, and one copy to the physician.
Boston Scientic Neuromodulation Corporation
25155 Rye Canyon Loop
Valencia, California 91355, USA
Attention: Customer Service Department
Instructions for Use
Physician training is required. Boston Scientic also recommends that implanting physicians read all product labeling prior to using our devices.
Lead, Lead Extension, and Splitter Handling and Storage
• Avoid damaging the Lead with sharp instruments or excessive force during surgery.
• Do not sharply bend or kink the Lead, extension, or Splitter.
• Do not tie suture(s) directly to the Lead, extension, or Splitter body; use the provided suture sleeves.
• For the Percutaneous Leads avoid forcing the Lead into the epidural or subcutaneous space by carefully clearing a path using the
Lead blank.
• Avoid pulling an implanted Lead taut; provide a stress relief loop at the insertion site to minimize tension on the Lead.
• Avoid handling the Lead with sharp instruments; use only rubber-tipped forceps.
• Take care when using sharp instruments such as hemostats or scalpels to prevent damaging the Lead.
• Wipe off any body uids from the Lead connector end before connecting it to any other component. Fluid contamination of these
connections could compromise the integrity of the stimulation circuit.
• Wipe off any body uids from the Lead stylet before inserting or reinserting it into the Lead.
Store components between 0 °C and 45 °C (32 °F and 113 °F) in an area where they are not exposed to liquids or excessive moisture.
Temperatures outside of the stated range can cause damage.
Innion CX Lead
The Innion 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 t through a
standard 14 gauge insertion needle or Epimed needle, therefore these needles are not compatible with the Innion CX Lead. Do not use a standard
14 gauge introducer or Epimed needle to introduce the Innion CX Lead.
Use only the Entrada Needle with peelable sheath to introduce the Innion CX Lead into the epidural or subcutaneous space.
An Anchor must be pre-loaded on the distal end of the Innion CX Lead prior to inserting the Lead into the Entrada Needle. When using an Anchor
or suture sleeve with the Innion 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 Innion CX Lead into the epidural or subcutaneous space. The Entrada Needle
may also be used with all percutaneous Leads listed under “Product Model Numbers” on page ii.
Fully Assembled Entrada Needle
5

Instructions for Use
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Components
Components are marked with dots to indicate use order, and the dots should be in the same direction when assembling the needle.
5
5
5
5
Needle Stylet, •
Loss of Resistance (LOR) adaptor, ••
Slotted Needle, •••
Peelable Sheath
Note: Do not mix components between Entrada 4.5 in and 6.0 in needles. Needles are clearly labeled with needle lengths and are also color coded
(as they appear on the product, green=6.0 in and blue=4.5 in).
Assembling and Reassembling the Entrada Needle
CAUTION: Do not insert or reinsert the needle stylet, LOR adaptor, or slotted needle into the sheath while the sheath is inserted within the
patient.
1. Insert the slotted needle into the sheath.
2. Insert the LOR adaptor into the slotted needle.
3. Insert the needle stylet into LOR adaptor and advance forward until fully seated into needle assembly.
Lead Placement for Spinal Cord Stimulation (SCS)
Note: If using an Innion™ CX Lead, proceed to “Innion CX Lead Placement for SCS Using the Entrada Needle” on page 6
1. Position, prep and drape the patient in the usual accepted manner. Inject a local anesthetic at the needle insertion site.
2. Under uoroscopic guidance, place the insertion needle into the epidural space with the bevel facing up using an angle of 45° or less.
CAUTION: Use only an insertion needle provided by Boston Scientic. Other needles may damage the Lead. The stamped number “14” on the
needle hub (or the triangle on the hub of the curved Epimed needle, sold separately) corresponds to the orientation of the bevel, which must face
up. Turning the bevel ventral (down) may result in Lead damage. An angle of more than 45° increases the risk of Lead damage.
WARNING: The angle of the insertion needle should be 45° or less. Steep angles increase the insertion force of the stylet and also present more
of an opportunity for the stylet to pierce the Lead and cause tissue damage.
3. Remove the needle stylet from the insertion needle and verify entry into the epidural space using the standard technique.

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4. OPTIONAL. Under uoroscopic guidance, insert the Lead blank through the insertion needle and into the epidural space. Advance the Lead blank
to verify entry into the epidural space, then withdraw the blank.
5. While holding the Lead stylet handle, place the steering cap over the proximal end of the stylet handle with moderate force until it is held in place.
Then slowly insert the Lead, with stylet, through the insertion needle. The Lead stylet should extend to the tip of the Lead.
6. OPTIONAL. If exchange of the Lead stylet is desired, carefully pull out the existing stylet and insert the preferred stylet. While inserting the stylet
into the Lead, if resistance is encountered, withdraw the stylet approximately 3 cm, rotate the Lead and/or stylet, and gently advance the stylet. If
resistance is still encountered, repeat the above procedure until the stylet can be fully inserted.
WARNING: Do not exchange the Lead stylet while the electrode array of the Lead is in the bevel of the insertion needle. If the electrode array
is in the bevel area, remove the Lead from the insertion needle before exchanging the stylet. Inserting the Lead stylet in the Lead while the
electrode array is in the bevel of the insertion needle increases the risk of Lead and tissue damage.
WARNING: If the Lead stylet is removed and reinserted, do not use excessive force when inserting the stylet into the Lead. The use of
instruments, such as forceps, to grasp the stylet during insertion is not recommended as this could result in applying excessive force and could
increase the risk of Lead and tissue damage.
7. Advance the Lead to the appropriate vertebral level under uoroscopic guidance. A sufcient length of Lead (for example, at least 10 cm, or
approximately three vertebrae) should reside in the epidural space to aid in Lead stabilization.
8. If using a Splitter, proceed to “Lead Connection to Splitter” in this manual. If not using a Splitter, proceed to the instructions for connecting Leads
or extensions to the OR Cable assembly in the appropriate DFU for your SCS System, as listed in your Reference Guide.
Innion CX Lead Placement for SCS Using the Entrada Needle
1. Position, prep and drape the patient in the usual accepted manner. Inject a local anesthetic at the needle insertion site.
2. Verify that the Entrada needle is fully assembled by holding onto the sheath hub and applying forward pressure on the stylet cap cover.
CAUTION: Do not bend the Entrada needle. Bending the Entrada needle may cause the stylet or LOR adapter to become jammed in the needle
assembly and difcult to remove.
3. Recommended for permanent or permanent-trial procedures: Cut down prior to inserting the Entrada Needle and insert needle into incision.
Creating the incision before inserting the Entrada Needle provides a clear path for sliding the Anchor into the incision.
If cutting down after inserting the Entrada Needle, ensure that the sheath is in place and do not damage the sheath.
4. Under uoroscopic guidance, place the Entrada Needle into the epidural space with the 14G marking facing up using an angle of 45° or less.
CAUTION: Use only an Entrada Needle provided by Boston Scientic. Other needles may damage the Lead. Turning the bevel ventral (down)
may result in Lead damage. An angle of more than 45° increases the risk of Lead damage.
WARNING: The angle of the insertion needle should be 45° or less. Steep angles increase the insertion force of the stylet and also present more
of an opportunity for the stylet to pierce the Lead and cause tissue damage.
Note: If the needle must be repositioned during this procedure, or if the sheath becomes damaged, reassemble the needle outside of the
body with a new sheath, see “Assembling and Reassembling the Entrada Needle” section of this manual.