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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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

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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.

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5. Remove the needle stylet from the insertion needle and verify entry into the epidural space using the standard technique.
Remove needle stylet Verify entry into the epidural space.
6. OPTIONAL. Under uoroscopic guidance, insert the Lead blank through the LOR adaptor and into the epidural space. Advance the Lead blank to
verify entry into the epidural space, then withdraw the blank.
7. The LOR adaptor must be removed prior to inserting the Lead. Pull the LOR adaptor straight out from the slotted needle without twisting or
bending.
Recommended: Hold the slotted needle in place while removing the LOR adaptor.
Note: An Anchor must be loaded over the distal end of the Innion CX Lead prior to inserting the Lead into the Entrada Needle.
8. 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. The Lead stylet should be fully inserted into the Lead. Slowly insert the Innion CX Lead into the slotted needle, directing the distal Lead
tip into the needle lumen.
OPTIONAL. Cover slotted needle with nger to aid in insertion of Innion CX Lead into slotted needle lumen.
OPTIONAL. If needle steering within the slotted needle is not needed, remove slotted needle and insert Lead directly into sheath.
9. OPTIONAL. If exchange of the Lead stylet is desired, carefully pull out the existing stylet and insert the preferred stylet. The stylet must be
inserted into the Innion CX Lead tail with one marker band. 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.
The stylet must be inserted into the Innion CX Lead tail with one marker band

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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.
10. Advance the Lead to the appropriate vertebral level under uoroscopic guidance. A sufcient length of Lead (at least 10 cm, or approximately
three vertebrae) should reside in the epidural space to aid in Lead stabilization.
11. Proceed to the instructions for connecting to the OR Cable assembly in the appropriate DFU for your SCS System, as listed in your Reference
Guide.
Peripheral Nerve Stimulation (PNS)
When using the Boston Scientic Systems for PNS, the pre-loaded, curved Lead stylet is not recommended. Replace the curved Lead stylet with a
straight Lead stylet before starting the PNS procedure. Carefully pull out the curved Lead stylet and insert the preferred straight Lead stylet. If using
the Innion CX Lead, insert the straight stylet into the Lead tail that has one marker band. If resistance is encountered while inserting the Lead stylet,
withdraw the Lead stylet approximately 3 cm, rotate the Lead and/or Lead stylet and gently advance the Lead stylet. If resistance is still encountered,
repeat this step until the straight Lead stylet can be fully inserted.
WARNING: Do not exchange or insert the Lead stylet while the electrode array of the Lead is in the bevel of the insertion needle. 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. If the
electrode array is in the bevel area, remove the Lead from the insertion needle before exchanging the stylet.
WARNING: Do not use excessive force when inserting the Lead stylet into the Lead. The use of instruments, such as forceps, to grasp the stylet
during insertion could result in applying excessive force and increase the risk of Lead and tissue damage.
CAUTION: Proceed with care, because the proximal Lead tail is susceptible to contamination and could cause infection.
Note: If using an Innion CX Lead, see “Innion CX Lead Placement with Entrada™ Needle for PNS” on page 8.
Lead Placement for PNS
1. Position, prep, and drape the patient in the usual accepted manner. Inject a local anesthetic at the needle insertion site. Be careful to avoid
anesthetizing the target nerve(s) (minimize lateral injections, minimize injection volume).
2. With the needle stylet inserted, insert the needle provided in the Lead Kit into the subcutaneous tissue plane and advance the needle to the target
location. The needle can be advanced slightly beyond the target location to allow for more proximal repositioning during intraoperative testing.
Pinching supercial tissue away from the fascial layer helps guide the needle within the subcutaneous fat.
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, corresponds to the orientation of the bevel.
Note: To avoid engaging the dermis, place the bevel of the needle face down from the dermal interface and pinch the skin.
CAUTION: If electrodes are too close to (or through) the fascia, the patient may experience painful direct muscle stimulation. If electrodes are too
supercial, the risk of electrode erosion is increased.
3. Remove the needle stylet from the insertion needle.
4. Slowly introduce the Lead, with straight Lead stylet, through the insertion needle to the tip of the needle.
5. Carefully withdraw the insertion needle to expose the Lead contacts by slowly pulling the needle towards the proximal end of the Lead while
keeping the Lead in the desired location.
WARNING: Only advance the needle with the needle stylet in place. Failure to do so may result in tissue coring.
CAUTION: If the Lead is exposed beyond the tip of the needle, do not advance the needle or withdraw the Lead back through the needle.
Advancing the needle after the Lead is exposed beyond the tip of the needle may cause damage to the Lead or inadequate stimulation.
CAUTION: Do not completely remove the needle. Only remove the needle enough to expose the contacts.
CAUTION: Do not withdraw the needle past the anchoring site prior to creating the anchor site incision.
6. If performing a temporary Lead Trial procedure, connect to the OR Cable assembly and External Trial Stimulator. Follow the instructions in the
appropriate DFU for your Boston Scientic System as listed in your Reference Guide.
Innion CX Lead Placement with Entrada™ Needle for PNS
1. Position, prep, and drape the patient in the usual accepted manner. Inject a local anesthetic at the needle insertion site. Be careful to avoid
anesthetizing the target nerve(s) (minimize lateral injections, minimize injection volume).
Note: 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.
2. Verify that the Entrada Needle is fully assembled by holding the sheath hub and applying forward pressure on the stylet cap cover.

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CAUTION: Do not bend the Entrada Needle. Bending the Entrada Needle may cause the stylet or Loss of Resistance (LOR) adaptor 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. Avoid damaging the sheath.
4. Insert the Entrada Needle into the subcutaneous tissue plane. The “14G” marking corresponds to the orientation of the bevel. Advance the
needle to the target location. The needle can be advanced slightly beyond the target location to allow for more proximal repositioning during
intraoperative testing. Pinching supercial tissue away from the fascial layer helps guide the needle within the subcutaneous fat.
CAUTION: Use only the Entrada Needle provided by Boston Scientic. Other needles may damage the Innion CX Lead.
WARNING: Steep angles increase the insertion force of the stylet and also increase the risk of the stylet piercing the Lead and causing 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. Follow the instructions in your Percutaneous Leads DFU.
Note: To avoid engaging the dermis, place the bevel of the needle face down from the dermal interface and pinch the skin.
CAUTION: If electrodes are too close to (or through) the fascia, the patient may experience painful direct muscle stimulation. If they are too
supercial, the risk of electrode erosion is increased.
5. Remove the needle stylet from the insertion needle.
6. Pull the LOR adaptor straight out from the slotted needle without twisting or bending.
Recommended: Hold the slotted needle in place while removing the LOR adaptor.
Note: The LOR adaptor and steering cap are not needed for PNS; however, the full needle should remain assembled for initial Lead insertions.
7. If using an anchor, load the anchor over the distal end of the Innion CX Lead.
8. Slowly insert the Innion CX Lead into the slotted needle, directing the distal Lead tip into the needle lumen.
–Optional– Cover the slotted needle with nger to aid in insertion of the Innion CX Lead into the slotted needle lumen.
–Optional– If needle steering within the slotted needle is not needed, remove the slotted needle and insert the Lead directly into sheath.
9. Carefully withdraw the insertion needle to expose the Lead contacts by slowly pulling the needle towards the proximal end of the Lead while
keeping the Lead in the desired location.
WARNING: Only advance the needle with the needle stylet in place. Failure to do so may result in tissue coring.
CAUTION: If the Lead is exposed beyond the tip of the needle, do not advance the needle or withdraw the Lead back through the needle.
Advancing the needle after the Lead is exposed beyond the tip of the needle may damage the Lead or cause inadequate stimulation.
CAUTION: Do not completely remove the needle. Only remove the needle enough to expose the contacts.
CAUTION: Do not withdraw the needle past the anchoring site prior to creating the anchor site incision.
10. For temporary Lead trials, connect to the OR Cable assembly and External Trial Stimulator. Follow the instructions in the appropriate DFU for
your Boston Scientic System as listed in your Reference Guide.
Lead Connection to Splitter
1. Carefully withdraw the stylets from the Leads to be inserted into the Splitter.
2. Wipe clean the proximal connector ends of the Leads.
3. Select the desired Splitter model.
Note: A Splitter 2x8 must be used when implanting the Innion 16 Lead.
4. Check that the Lead connector end can be easily inserted into the Splitter without obstruction. If obstruction is encountered, loosen the set screws
of the Splitter by using the hex wrench provided, turning counterclockwise.
Note:
• The set screw should only be loosened to an amount sufcient to insert a Lead.
• Do not excessively loosen the set screw. This may cause the set screw to dislodge rendering the Splitter unusable.
5. Insert proximal connector ends of desired Leads into Splitter receptacles until they are fully seated - each Lead bottoms out in receptacles and
retention sleeves (long ring) are under the set screw blocks of the Splitter receptacles. Do not tighten set screw at this time.
6. Proceed to instructions to connect the Leads to the OR Cable Assembly in the appropriate DFU for your system as listed in your Reference
Guide.

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7. Check connections with an impedance measurement. If the impedance is satisfactory proceed to “Intraoperative Stimulation Testing” on
page 10 to conrm proper Lead location.
Note: Do not tighten set screw mechanical lock before intraoperative stimulation testing,
Note: On the 2x4 Splitter, the shorter Splitter receptacle corresponds to contacts 1-4, while the longer receptacle corresponds to contacts 5-8.
Make note of which Lead is connected to each Splitter receptacle.
Note: On the Splitter 2x8, one tail is laser-marked with bands, and corresponds to contacts 1-8 on the 16 contact percutaneous Leads; the
unmarked tail corresponds to contacts 9-16.
8. If Lead repositioning is required, disconnect the Splitter and reinsert the stylet before advancing the Lead. Repeat steps 5 to 7 until satisfactory
Lead position is achieved.
9. Use the hex wrench supplied to tighten down the setscrews until the wrench clicks.
Medical Adhesive
10. If using the Splitter 2x8, prior to closing the wound, clean the top of the Splitter set-screw seal plug and use silicone medical adhesive (e.g. Dow
Corning Silastic® Medical Adhesive Silicone, Type A - Sterile, as available from Boston Scientic, part number SC-4320) to coat and seal the top
of the seal plug that has been penetrated by the hex wrench.
Note: Inadvertent damage to the septum seal may Lead to unintended stimulation at the Splitter 2x8 if the Medical Adhesive is not used as
intended.
11. To connect to a Trial Stimulator for intraoperative testing, or to connect to an IPG, proceed to the applicable instructions in the appropriate DFU
for your System as listed in your Reference Guide.
Intraoperative Stimulation Testing
Note: The following steps are for procedural reference only. For detailed stimulation testing procedures and guidelines refer to the appropriate
programming manual for your system as listed in the Reference Guide.
1. If using a Splitter
• Visually check Splitter to Leads connection
• Check impedance
Note: If using the 2x4 Splitter, make note of Splitter conguration in the Programming software. Refer to the appropriate programming manual
for your System as listed in your Reference Guide.
2. After linking the Clinician Programmer to the Trial Stimulator, check impedances to verify that components are properly connected. Lead impedance
is measured and displayed for each of the IPG’s contacts. Impedances, indicated by an x or an orange circle in your Programming Software, are
considered to be resultant from open or unconnected wires. Refer to your Programming Manual for additional information.
3. Using test stimulation, enlist patient feedback to verify Lead placement and pain coverage.
Note: If Lead repositioning is necessary, turn stimulation off before proceeding.
4. Reposition Leads as necessary. If using a Splitter, gently pull on Lead attached to Splitter to reposition caudad or disconnect Splitter from Leads,
re-insert stylet, and advance Leads to reposition cephalad.
CAUTION: Do not force stylet into Lead.
5. Steer Lead to new position.
6. Remove stylet, wipe proximal ends of Leads, and reconnect Splitter.
7. Check impedances.
8. Repeat steps 1-3 if Lead has been repositioned.
9. When the desired Lead placement is achieved:
a) Turn the Trial Stimulator off.
b) Unlock each OR cable connector and disconnect from the Lead(s).
c) For percutaneous Lead(s) - Slowly withdraw the stylet(s).

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10. Record the Lead position by capturing a uoroscopic image to be sure the Leads have not moved. Retest if necessary.
11. If using a Splitter disconnect Splitter from Leads. Insert the hex wrench and turn the set screw counter clockwise to loosen.
Note: • The set screw should only be loosened to an amount sufcient to insert a Lead.
• Do not excessively loosen the set screw. This may cause the set screw to dislodge, rendering the Splitter unusable.
Option A: For a Temporary Trial, proceed to “Securing the Trial Lead” on page 11.
Option B: For a Permanent Trial, proceed to “Permanent Lead Anchoring and Tunneling” on page 11.
Option C: For a Permanent IPG Implantation using percutaneous Leads, proceed to “Permanent Lead Anchoring and Tunneling” on page 11.
Option D: For SCS only - For a Permanent IPG Implantation using paddle Leads, proceed to “Permanent Lead Anchoring and Tunneling” in the
Surgical Leads DFU.
Before receiving a permanent system, it is recommended that patients undergo a trial procedure so that they can experience stimulation to evaluate
if SCS or PNS is effective at treating their chronic pain.
Securing the Trial Lead
Note: If using an Innion CX Trial Lead, proceed to “Securing the Trial Innion CX Lead”.
1. Carefully withdraw the insertion needle from the epidural or subcutaneous space by slowly pulling the needle up towards the proximal end of the
Lead while holding the Lead in place.
2. Once the insertion needle tip is exposed, hold the Lead as close to the percutaneous exit site as possible, then carefully pull the needle
completely from the Lead.
3. If desired, a suture may be used to close the wound and stabilize the Lead.
4. Place and tape a stress relief loop and dress the wound.
5. If using a Splitter, see “Lead Connection to Splitter” section of this manual.
For temporary Lead trials, refer to the instructions for connecting to the OR Cable Assembly and External Trial Stimulator in the appropriate DFU for
your System as listed in your Reference Guide.
Securing the Trial Innion CX Lead
1. Carefully withdraw the slotted needle by slowly pulling the needle towards the proximal end of the Lead while stabilizing Lead in line with the slot
to keep Lead in place.
Note: Do not reinsert the slotted needle into the sheath while the sheath is within the body.
2. Snap sheath wings apart and peel sheath out of insertion site.
3. Remove the stylet from the Lead.
4. If desired, a suture may be used to close the wound and stabilize the Lead.
5. Place and tape a stress relief loop and dress the wound.
For temporary Lead trials, refer to the instructions for connecting to the OR Cable assembly and External Trial Stimulator in the appropriate DFU for
your System as listed in your Reference Guide.
Permanent Lead Anchoring and Tunneling
Removing the Insertion Needle
Note: If using an Entrada Needle, proceed to “Removing the Entrada Needle”.
1. Cut down around the insertion needle to provide access for Anchoring the Lead.
2. Carefully withdraw the insertion needle from the epidural or subcutaneous space by slowly pulling the needle up towards the proximal end of the
Lead while holding the Lead in place.

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3. Once the insertion needle tip is exposed, hold the Lead as close to the exit site as possible, then carefully pull the needle completely from the
Lead.
Removing the Entrada Needle
1. Carefully withdraw the slotted needle by slowly pulling the needle towards the proximal end of the Lead while stabilizing Lead in line with the slot
to keep Lead in place.
Note: Do not reinsert the slotted needle into the sheath while the sheath is within the body.
15a
Stabilize Lead in line with the slot. Slowly remove slotted needle.
2. Snap sheath wings apart and peel sheath out of insertion site.
Snap sheath wings apart and peel sheath
3. Remove the stylet from the Lead.
Anchoring the Lead for SCS
Leads can be permanently Anchored with a suture sleeve or with an Anchor.
Note: When using the Innion CX Lead, the Anchor or suture sleeve must be loaded over the distal end of the Lead prior to inserting the Innion CX
Lead into the Entrada Needle. For the Innion CX Lead, the stylet may be in place within the Lead when the Anchor is loaded on the Lead,
however, the stylet must be removed before the Anchor is locked down.
Refer to the Directions for Use for your Boston Scientic Anchor as listed in your Reference Guide, or continue with the following steps to Anchor
using a suture sleeve.
1. For percutaneous Leads, carefully remove the Lead stylet using uoroscopy to ensure the Lead position does not change.
2. Place a suture sleeve over the Lead and down to the supraspinous ligament or deep fascial tissue.
3. Ligate the suture sleeve onto the Lead by tying a 2-0 silk or other nonabsorbable suture around the center groove of the sleeve to prevent sliding.
Circumferential stitches may be tied at the compression slots.
CAUTION: Do not use polypropylene sutures as they may damage the suture sleeve. Do not suture directly onto the Lead, Splitter, or use a
hemostat on the Lead body. This may damage the Lead insulation.
Note: The 4 cm and 2.3 cm Suture Sleeves each have three (3) compression slots, which are designed to reduce slippage.
4. Suture the sleeve to the supraspinous ligament or deep fascia through the suture sleeve holes.
5. Tie multiple sutures as tightly as possible around the suture sleeve to secure it to the Lead.
CAUTION: Tightening sutures directly on the Lead can damage the Lead.

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6. For Permanent Trials, proceed to “Tunneling the Lead or Lead Extension” on page 13.
7. For permanent IPG implantation refer to IPG instructions in the appropriate DFU for your system as listed in your Reference Guide.
Anchoring the Lead for PNS
Leads can be permanently anchored with a suture sleeve or with an anchor.
Note: When using the Innion CX Lead, the anchor or suture sleeve must be loaded over the distal end of the Lead prior to inserting the Innion
CX Lead into the Entrada Needle. For the Innion CX Lead, the Lead stylet may be in place within the Lead when the anchor is loaded on the
Lead, but the stylet must be removed before the anchor is locked down.
Refer to the Directions for Use for your Boston Scientic Anchor as listed in your Reference Guide, or continue with the following steps to Anchor
using a suture sleeve.
1. Using standard surgical technique, cut down to the anchoring site.
CAUTION: Avoid damaging the Lead when cutting down to the anchoring site.
2. Remove the needle while keeping the Lead in place, see “Removing the Insertion Needle” on page 11.
IMPORTANT: Once the insertion needle tip is exposed, hold the Lead as close to the percutaneous exit site as possible, then carefully pull the
needle completely from the Lead.
3. For all percutaneous Leads except the Innion CX Leads, place an anchor over the Lead and ensure correct location.
4. Secure the anchor to the appropriate tissue.
CAUTION: Do not suture directly onto the Lead or use a hemostat on the Lead body. Suturing directly onto the Lead or using a hemostat on the
Lead body may damage the Lead.
5. Secure the Lead with a suture sleeve by tightening the sleeve around the Lead with a non-absorbable suture.
6. For Permanent Trials, proceed to “Tunneling the Lead or Lead Extension” on page 13.
7. For permanent IPG implantation refer to IPG instructions in the appropriate DFU for your system as listed in your Reference Guide.
Tunneling the Lead or Lead Extension
1. Attach the tunneling tool handle to the shaft by turning the locking mechanism clockwise.
Tool Handle
Locking Mechanism
Shaft
2. Mark the desired route of the tunnel.
3. Administer the appropriate local anesthetic along the tunneling path.
4. OPTIONAL. If necessary, bend the tool shaft to conform to the patient’s body.

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5. Make a small incision at the desired exit site.
6. Create a subcutaneous tunnel between the midline or anchor incision and the exit site until the straw is visible and accessible at the exit point.
7. Unscrew and remove the tunneling tool handle.
8. Grasp the tip of the tool with one hand while holding the straw in place with the other hand. Pull the tunneling tool shaft out through the straw.
9. Push the Lead or extension proximal ends through the straw, then withdraw the straw.
CAUTION: Do not tunnel Splitter.
Note: If using the 2x8 Splitter and performing a permanent trial, the Splitter tails may be tunneled to the exit site.
10. For Permanent Trials: If using the Innion 1x16 Lead, proceed to “Lead Connection to Splitter” on page 9. Otherwise, proceed to “Connecting
the Lead Extension” on page 14.
11. For Permanent IPG Implantation, if extensions are used, proceed to the instructions for “Connecting the Lead Extension” on page 14.
12. For Permanent IPG Implantation, if Splitters are used, proceed to the instructions for “Lead Connection to Splitter” on page 9.
13. For permanent IPG implantation, refer to the IPG instructions in the appropriate DFU for your system as listed in your Reference Guide.
Note: The following Codman Disposable Catheter Passers may be used in place of the Boston Scientic tunneling tool except when tunneling
the Innion CX Lead:
REF 82-1515 (36 cm); REF 82-1516 (55 cm); REF 82-1517 (65 cm)
Note: When using a Codman Disposable Catheter Passer, tunnel from the IPG pocket to the midline or anchor incision using the standard
technique.
Connecting the Lead Extension
1. Wipe clean the proximal end of the Lead, then insert the proximal end into the Lead extension connector or Splitter until it stops and the retention
ring (long ring) is under the setscrew.
Note: If there appears to be an obstruction when inserting the Lead into the Lead extension connector, use the hex wrench to loosen
(counterclockwise) the setscrew and/or gently rotate the Lead to help advance the proximal end.
2. Ensure that the Lead is fully inserted before tightening the set screw to prevent Lead damage.
3. Using the hex wrench supplied, turn the extension connector setscrew clockwise until it clicks, indicating lock.

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Note: Ensure that the hex wrench is fully seated in the setscrew before tightening.
Note: The hex wrench is torque-limited and cannot be overtightened.
4. Form an appropriately-sized pocket using blunt dissection on either side of midline or anchor incision for coiled excess Lead and extension
connectors.
5. Place a small loop at the Lead for slack. If necessary, loosely tie a suture around the Lead-loop, but do not tighten onto the Lead.
CAUTION: Tightening sutures directly on the Lead can damage the Lead.
6. Carefully remove excess slack by gently pulling the extensions from the exit wound.
7. For Permanent Trials, if desired, a small suture may be used to close the exit wound of the extension. Place and tape a stress relief loop and
dress the wound. Proceed to the instructions for connecting to the OR Cable Connector or External Trial Stimulator in the appropriate DFU for
your System, as listed in your Reference Guide.
8. For permanent Implant, close the midline or anchor incision and proceed to instructions to instructions for connecting to the IPG in the appropriate
DFU for your System, as listed in your Reference Guide.
Lead/Extension/Splitter Removal
Remove bandages and properly cleanse the exit site. The method of removal depends upon whether a temporary trial or permanent trial was
performed.
Option A: Lead Removal after Temporary Trial
1. Clip sutures if used to secure the trial Lead(s) in place.
2. Remove the Lead(s) and discard.
3. To replace the trial Lead(s) with permanent percutaneous Lead(s), proceed to the instructions for “Lead Placement for Spinal Cord Stimulation
(SCS)” on page 5 or “Lead Placement for PNS” on page 8.
4. For SCS only - To replace the trial Lead(s) with a paddle Lead proceed to instructions for “Surgical Paddle Lead Placement in the Epidural Space”
in the Surgical Leads DFU.
Option B: Lead Extension Removal After Permanent Trial
1. Open the midline or anchor incision to expose the Lead extension and connector.
2. Cut the Lead extension at the connector. Do not cut the implanted Lead.

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3. Remove the extension, being careful not to contact non-sterile portions to the patient’s body.
4. Loosen the extension connector setscrew using the hex wrench. Disconnect and remove the connector without moving the implanted Lead.
5. Proceed to the IPG Implantation instructions in the appropriate DFU for your system as listed in your Reference Guide.
Option C: Splitter Removal
1. If the Splitter has been implanted, open the incision to expose the Lead and Splitter junction.
2. Loosen the connector set screw on the Splitter receptacles using the hex wrench provided.
3. Disconnect and discard the Splitter components.
Option D: Permanent Lead Removal for PNS
1. Using standard surgical technique, re-open the implant wound.
CAUTION: Avoid damaging the Lead when cutting down to the anchoring site.
2. Clip sutures used to secure the Lead and undo anchoring.
3. Disconnect the Lead from the IPG or extension.
CAUTION: Avoid damaging the Lead when clipping sutures.
4. Remove the Lead and follow the instructions for Component Disposal in the appropriate DFU for your Boston Scientic System as listed in your
Reference Guide.
–or–
Remove the Lead and revise the Lead placement, see “Lead Placement for PNS” on page 8.
Programming with the Innion 16 Lead and Innion CX Lead
For detailed programming instructions, refer to the appropriate Bionic Navigator Software Guide or the Bionic Navigator 3D System Programming
Manual.
If using the Bionic Navigator 3D software:
When the Innion 16 Lead is used with the Splitter 2x8 and placed properly into the ports of the 4-port IPG (the Splitter tail with laser etched
bands to the left ports A or C and the unmarked Splitter tail to the right ports B or D) the laser marked Splitter tail corresponds to contacts
1-8 on the distal end of the Innion 16 Lead and the unmarked Splitter tail corresponds to contacts 9-16 of the Innion 16 Lead.
When the Innion CX Lead is placed properly into the ports of the 4-port IPG (tail with one marker band to the left ports A or C
and tail with two marker bands to the right ports B or D) the tail with one marker band corresponds to contacts 1-8 on the distal
end of the Innion CX Lead and the tail with two marker bands corresponds to contacts 9-16 of the Innion CX Lead.
If using Bionic Navigator Software:
When the Innion 16 Lead is used with the Splitter 2x8 and placed properly into the Precision IPG ports (laser-marked tail
of Splitter 2x8 connecting to IPG port “1-L”), the distal 8 contacts of the Innion 16 Lead (contacts 1-8) will correspond with
contacts 1-8 on the left side of the Bionic Navigator™ software display. Likewise, the proximal 8 contacts of the Innion 16
Lead (contacts 9-16) will correspond with contact 9-16 on the right side of the Bionic Navigator software display.
When the Innion CX Lead is placed properly into the Precision IPG ports (tail with one marker band connecting to IPG port “1-L”), the distal 8 contacts
of the Innion CX Lead (contacts 1-8) will correspond with contacts 1-8 on the left side of the Bionic Navigator software display. Likewise, the proximal
8 contacts of the Innion CX Lead (contacts 9-16) will correspond with contact 9-16 on the right side of the Bionic Navigator software display.
The diagram below depicts this wiring. Using test stimulation, enlist patient feedback to verify Lead placement and pain coverage. The user may
program with the Innion 16 Lead and Innion CX Lead using all the functions available in Bionic Navigator for the Linear family of Leads (E-Troll,
Navigator, etc.). For complete instructions on programming, see the appropriate Programming manual for your system as listed in your Reference
Guide.