Percutaneous Leads
Percutaneous Leads
Directions for Use
91078744-02 REV A
CAUTION: Federal law restricts this device to sale,
distribution and use by or on the order of a physician.
Percutaneous Leads Directions for Use
Guarantees
Boston Scientific 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 respective holders. .
Additional Information
For Indications and related information, see the Indications DFU or Clinician Manual for your spinal cord
stimulator system. For contraindications, warnings, precautions, adverse events summary, physician
instructions, sterilization, component disposal, and contact information for Boston Scientific, refer to the
Information for Prescribers DFU or Clinician Manual for your spinal cord stimulator system. For other
device-specific information not included in this manual, labeling symbols, and warranty, refer to the
appropriate DFU as listed on your Reference Guide.
For clinical studies supporting the clinical use of the neurostimulation system, refer to the
Information for Prescribers DFU or Clinician Manual for your spinal cord stimulator system.
Product Model Numbers
Model
Description
SC-2016-xx
Infinion™ 16 Lead and Splitter 2x8 Kit
SC-2016-xxE
Infinion 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 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 Lead
SC-2352-xx
Linear 3-4 xxcm 8 Contact Lead
SC-2352-xxE
Linear 3-4 xxcm 8 Contact Lead
SC-2366-xx
Linear 3-6 xxcm 8 Contact Lead
SC-2366-xxE
Linear 3-6 xxcm 8 Contact Lead
SC-3138-xx
xxcm 8 Contact Extension
SC-3304-xx
D4 Splitter 2x4
SC-3354-xx
W4 Splitter 2x4
SC-2316-xx
Infinion 16 xxcm 16 Contact Lead Kit
SC-2316-xxE
Infinion 16 xxcm 16 Contact Trial Lead Kit
SC-3400-xx
xxcm Splitter 2x8 Kit
SC-2317-xx
Infinion CX xxcm 16 Contact Lead Kit
SC-2317-xxE
Infinion CX xxcm 16 Contact Trial Lead Kit
Note: xx = length (cm), xxE = length (cm) Trial Lead
Percutaneous Leads Directions for Use
91078744-02 REV A ii of iv

Table of Contents
Description................................................................................................................................................1
Percutaneous Leads.............................................................................................................................1
Trial Leads............................................................................................................................................1
Lead Extension.....................................................................................................................................1
Infinion™ 16 Lead................................................................................................................................1
Infinion CX Lead...................................................................................................................................1
Lead Splitters........................................................................................................................................2
Package Contents....................................................................................................................................3
Percutaneous Permanent Lead Kits.....................................................................................................3
Percutaneous Trial Lead Kit.................................................................................................................3
Lead Extension Kit................................................................................................................................3
2x4 Splitter Kit......................................................................................................................................3
Splitter 2x8 Kit......................................................................................................................................3
Infinion 16 Lead Kit...............................................................................................................................4
Infinion 16 Trial Lead Kit.......................................................................................................................4
Infinion 16 Trial Configuration Kit..........................................................................................................4
Infinion 16 Configuration Kit.................................................................................................................4
Infinion CX Lead Kit..............................................................................................................................4
Infinion CX Trial Lead Kit......................................................................................................................4
Specifications and Technical Data..........................................................................................................5
Linear Lead...........................................................................................................................................5
Infinion 16 Lead....................................................................................................................................5
Infinion CX Lead...................................................................................................................................6
Lead Extension.....................................................................................................................................6
2x4 Splitter............................................................................................................................................6
Splitter 2x8............................................................................................................................................7
Registering the Leads..............................................................................................................................8
Instructions for Use..................................................................................................................................9
Lead, Lead Extension, and Splitter Handling and Storage...................................................................9
Percutaneous Lead Placement in the Epidural Space.........................................................................9
Infinion CX Lead Placement in the Epidural Space with Entrada Needle.......................................... 11
Lead Connection to Splitter................................................................................................................15
Intraoperative Stimulation Testing.......................................................................................................17
Securing the Trial Lead.......................................................................................................................18
Securing the Trial Infinion CX Lead....................................................................................................19
Permanent Lead Anchoring and Tunneling........................................................................................19
Tunneling the Lead or Lead Extension...............................................................................................21
Connecting the Lead Extension..........................................................................................................23
Lead/Extension/Splitter Removal.......................................................................................................24
Programming with the Infinion 16 Lead and Infinion CX Lead..........................................................25
Percutaneous Leads Directions for Use
91078744-02 REV A iii of iv
Percutaneous Leads Directions for Use
This page intentionally left blank
Percutaneous Leads Directions for Use
91078744-02 REV A iv of iv
Description
Description
Leads function as a component of Boston Scientific’s Precision, 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.
The Entrada™ Needle (Model SC-4220) functions as a component of Boston Scientific’s Precision,
Precision Novi and Precision Spectra Spinal Cord Stimulation (SCS) 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 Precision, 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™ 16 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 16 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.
Infinion CX Lead
The Infinion 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 Infinion CX lead can be connected
directly to a 2x8 OR Cable when using the Precision Spectra Trial Stimulator or two 1x8 OR Cables
when using the Precision Trial Stimulator. The Infinion CX Lead may be connected directly to the IPG’s 8
contact ports.
Percutaneous Leads Directions for Use
91078744-02 REV A 1 of 27
Percutaneous Leads Directions for Use
Lead Splitters
The 2x4 Lead Splitters are designed to connect multiple percutaneous leads to the Precision, Precision
Novi or Precision Spectra IPG. The Linear leads may be inserted into a splitter for a maximum of four
Linear leads per Precision and Precision Novi IPG and 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
91078744-02 REV A 2 of 27
Package Contents
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)
(1) Device Registration Form/Temporary Patient Identification Card
(1) Manual
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)
(1) Device Registration Form/Temporary Patient Identification Card
(1) Manual
Lead Extension Kit
(1) Lead Extension
(1) Hex Wrench
(1) Tunneling Tool Assembly
(1) Device Registration Form/Temporary Patient Identification Card
(1) Manual
2x4 Splitter Kit
(1) Splitter
(1) Hex wrench
(1) Manual
(1) Device Registration Form/Temporary Patient Identification Card
Splitter 2x8 Kit
(1) Splitter 2x8
(1) Torque Wrench
(1) Manual
(1) Device Registration Form/Temporary Patient Identification Card
Percutaneous Leads Directions for Use
91078744-02 REV A 3 of 27
Percutaneous Leads Directions for Use
Infinion 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) L ead Position Labels—left and right (non-sterile)
(1) Device Registration Form/Temporary Patient Identification Card
(1) Manual
Infinion 16 Trial Lead Kit
(1) 16 Contact Percutaneous Lead with pre-loaded Curved Stylet
(1) Suture Sleeve
(1) Insertion Needle
(1) Steering Cap
(2) L ead Position Labels—left and right (non-sterile)
(1) Device Registration Form/Temporary Patient identification Card
(1) Manual
Infinion 16 Trial Configuration Kit
(1) Infinion 16 Trial Lead Kit
(1) 2x8 Splitter Kit
Infinion 16 Configuration Kit
(1) Infinion 16 Lead Kit
(1) 2x8 Splitter Kit
Infinion CX Lead Kit
(1) 16 Contact Percutaneous Infinion CX Lead with pre-loaded Curved Stylet
(2) Suture Sleeves
(2) Lead Position Labels—left and right (non-sterile)
(1) Manual
(1) Product Registration Form/Temporary Patient Identification Card
(1) Steering Cap
Infinion CX Trial Lead Kit
(1) 16 Contact Percutaneous Infinion CX Lead with pre-loaded Curved Stylet
(2) Suture Sleeves
(2) Lead Position Labels—left and right (non-sterile)
(1) Manual
(1) Product Registration Form/Temporary Patient Identification Card
(1) Steering Cap
Percutaneous Leads Directions for Use
91078744-02 REV A 4 of 27
Specifications and Technical Data
Specifications and Technical Data
Linear Lead
Part
Specifications
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
Infinion 16 Lead
Part
Specifications
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
Percutaneous Leads Directions for Use
91078744-02 REV A 5 of 27
Percutaneous Leads Directions for Use
Infinion CX Lead
Part
Specifications
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
Specifications
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
Specifications
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
Percutaneous Leads Directions for Use
91078744-02 REV A 6 of 27
Specifications and Technical Data
Splitter 2x8
Part
Specifications
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
Percutaneous Leads Directions for Use
91078744-02 REV A 7 of 27
Percutaneous Leads Directions for Use
Registering the Leads
In accordance with international practice and regulatory legislation in some countries, a registration form is
packed with each Boston Scientific 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 specific 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 Scientific, keep
one copy for patient records, provide one copy to the patient, and one copy to the physician.
Boston Scientific Neuromodulation
25155 Rye Canyon Loop
Valencia, California 91355, USA
Attention: Customer Service Department
Percutaneous Leads Directions for Use
91078744-02 REV A 8 of 27
Instructions for Use
Instructions for Use
Physician training is required. Boston Scientific 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 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 fluids 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 fluids 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.
Percutaneous Lead Placement in the Epidural Space
Note: If using an Infinion CX Lead, proceed to “Infinion CX Lead Placement in the Epidural Space
with Entrada Needle” on page 11.
1. Position, prep and drape the patient in the usual accepted manner. Inject a local anesthetic at the
needle insertion site.
2. Under fluoroscopic 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 Scientific. 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.
Percutaneous Leads Directions for Use
91078744-02 REV A 9 of 27
Percutaneous Leads Directions for Use
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.
4. OPTIONAL. Under fluoroscopic 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 fluoroscopic guidance. A sufficient 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.
OR
If not using a splitter, proceed to the instructions for connecting to the OR Cable assembly:
• If using the Precision System, refer to “Connecting the OR Cable Assembly” in the Precision
Spinal Cord Stimulator System Clinician Manual.
• If using the Precision Spectra or Precision Novi System, refer to “Insert the Leads into the
OR Cable Connector” in the Clinician Trial Manual.
Percutaneous Leads Directions for Use
91078744-02 REV A 10 of 27
Instructions for Use
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 the
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.
An Entrada Needle with peelable sheath is required to introduce the Infinion CX Lead into the epidural
space and may be used with all percutaneous leads. Also, 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
Fully Assembled Entrada Needle
A. Peelable sheath
B. Slotted Needle
C. Loss of resistance (LOR)
adaptor
D. Needle stylet
Entrada Needle Assembly
A
B
C
D
A. Peelable Sheath
B. Slotted needle inserts into sheath
C. Insert LOR adaptor into slotted needle and lock on peelable sheath by turning clockwise
D. Needle stylet inserts into LOR adaptor
Percutaneous Leads Directions for Use
91078744-02 REV A 11 of 27
Percutaneous Leads Directions for Use
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 Luer lock collar of the LOR adaptor is locked on the peelable sheath and that the needle
stylet is fully inserted into the LOR adaptor hub before inserting the needle. To do so:
A. Pull back the stylet cap to expose the clear LOR adaptor hub.
B. Apply forward force to the LOR adaptor hub and rotate clockwise to fully engage onto the sheath
luer connection.
C. Straighten metal hub of LOR adaptor so that notch is facing up.
D. Straighten the stylet cap with flat side facing up and advance forward to fully seat into the needle
assembly.
A
B
C
D
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.
4. Under fluoroscopic guidance, place the Entrada Needle into the epidural space with the stylet cap flat
side facing up using an angle of 45° or less.
Percutaneous Leads Directions for Use
91078744-02 REV A 12 of 27
Instructions for Use
CAUTION: Use only an Entrada Needle provided by Boston Scientific. 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.
5. Remove the needle stylet from the insertion needle and verify entry into the epidural space using the
standard technique.
Note: Hold onto sheath wings when attaching syringe to LOR needle.
Note: Maintain positive pressure on the needle while performing LOR.
Remove needle stylet
Verify entry into the epidural space.
6. OPTIONAL. Under fluoroscopic 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 lead. Unscrew Luer lock collar and remove LOR
adaptor assembly from sheath while holding slotted needle in place.
Note: An anchor must be loaded over the distal end of the Infinion CX Lead prior to inserting the
lead into the Entrada Needle
Percutaneous Leads Directions for Use
91078744-02 REV A 13 of 27
Percutaneous Leads Directions for Use
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 extend to the tip of the lead. Slowly
insert the Infinion CX Lead into the slotted needle, directing the distal lead tip into the needle lumen.
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 Infinion 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 Infinion CX Lead tail with one marker band
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 fluoroscopic guidance. A sufficient length of
lead (i.e., at least 10 cm, or approximately three vertebrae) should reside in the epidural space to aid in
lead stabilization.
11.If the needle must be repositioned during the procedure, or if inserting a second Infinion CX Lead
through the same Entrada Needle with a new sheath, re-assemble needle outside of the body.
Reassemble Entrada Needle using new sheath
Percutaneous Leads Directions for Use
91078744-02 REV A 14 of 27
Instructions for Use
A
B
C
D
A. Sheath
B. Insert slotted needle into new sheath
C. Insert LOR adaptor into slotted needle and lock on peelable sheath by turning clockwise
D. Insert needle stylet into LOR adaptor and advance forward until fully seated into needle assembly.
CAUTION: Do not reinsert the needle stylet, LOR adaptor, or slotted needle into the sheath while the
sheath is inserted within the patient.
12.Proceed with needle insertion and lead placement
13.Proceed to the instructions for connecting to the OR Cable assembly:
• If using the Precision System, refer to “Connecting the OR Cable Assembly” in the Precision
Spinal Cord Stimulator System Clinician Manual.
• If using the Precision Spectra or Precision Novi System, refer to “Insert the Leads into the
OR Cable Connector” in the Clinician Trial Manual.
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 Infinion 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 sufficient to insert a lead.
•D
o 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. If using the Precision System, proceed to “Connecting to the OR Cable Assembly” in the Precision
Spinal Cord Stimulator System Clinician Manual.
OR
If using the Precision Spectra or Precision Novi System, proceed to “Insert the Leads into the OR
Cable Connector” in the Clinician Trial Manual.
7. Check connections with an impedance measurement. If the impedance is satisfactory proceed to
“Intraoperative Stimulation Testing” on page 17 to confirm 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.
Percutaneous Leads Directions for Use
91078744-02 REV A 15 of 27
Percutaneous Leads Directions for Use
Note: On the Splitter 2x8, one tail is laser-marked with bands, and corresponds to contacts 1-8 on
the Infinion 16 percutaneous lead; 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 Scientific, 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.For Intraoperative Testing proceed to the instructions for Connecting to the Trial Stimulator:
OR
• If using the Precision System, refer to “Connecting to the Trial Stimulator” in the Precision
Spinal Cord Stimulator System Clinician Manual.
• If using the Precision Spectra or Precision Novi System, refer to “Insert the Leads into the
OR Cable Connector” in the Clinician Trial Manual.
To connect to an IPG, refer to the directions as follows:
• If using the Precision System, refer to “Connecting to the IPG” in the Precision Spinal Cord
Stimulator System Clinician Manual.
Percutaneous Leads Directions for Use
91078744-02 REV A 16 of 27
Instructions for Use
• If using the Precision Spectra System, refer to “Connecting the Lead, Extension, Splitter, or
Connector to the IPG” in the Precision Spectra System Implantable Pulse Generator DFU.
• If using the Precision Novi System, refer to “Connecting the Lead, Extension, Splitter, or
Connector to the IPG” in the Precision Novi System Implantable Pulse Generator DFU.
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:
• If using the Precision System, refer to the Bionic Navigator Software Guide.
• If using the Precision Spectra or Precision Novi System, refer to the Bionic Navigator 3D
System Programming Manual.
1. If using a splitter
• Visually check splitter to leads connection
• Check impedance
Note: If using the 2x4 Splitter, make note of splitter configuration in the Programming software:
• If using the Precision System, refer to the Splitter Programming Guide for Bionic
Navigator software.
• If using the Precision Spectra or Precision Novi System, refer to the Bionic Navigator 3D
System Programming Manual.
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:
• For the Precision System, impedance is measured and displayed for each of the IPG’s 16
contacts. Impedances are displayed with an x on the Bionic Navigator software.
• For the Precision Spectra System impedance is measured and displayed for each of the
IPG’s 32 contacts. For the Precision Novi System, impedance is measured and displayed
for each of the IPG’s 16 contacts. Refer to Bionic Navigator 3D System Programming
Manual for additional information on how impedances are displayed on the Bionic
Navigator 3D System software.
Impedances, indicated by an x on your Bionic Navigator software or indicated by an orange circle on
the Bionic Navigator 3D software are considered to be resultant from open or unconnected wires.
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.
Percutaneous Leads Directions for Use
91078744-02 REV A 17 of 27
Percutaneous Leads Directions for Use
9. When the desired paresthesia 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).
10.Record the lead position by capturing a fluoroscopic 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 sufficient 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 18.
Option B: For a Permanent Trial, proceed to “Permanent Lead Anchoring and Tunneling” on page 19.
Option C: For a Permanent IPG Implantation using percutaneous leads, proceed to “Permanent Lead
Anchoring and Tunneling” on page 19.
Option D: For a Permanent IPG Implantation using paddle leads, proceed to “Permanent Lead Anchoring
and Tunneling” in the Surgical Leads DFU.
Before receiving a permanent SCS system, it is recommended that patients undergo a trial procedure so
that they can experience stimulation to evaluate if SCS is effective at treating their chronic pain.
Securing the Trial Lead
Note: If using an Infinion CX Trial Lead, proceed to “Securing the Trial Infinion CX Lead”.
1. Carefully withdraw the insertion needle from the epidural 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, refer to “Lead Connection to Splitter” on page 15.
6. For temporary lead trials, refer to “Connecting to the Trial Stimulator” in the Precision Spinal Cord
Stimulator System Clinician Manual for instructions on connecting to the OR Cable assembly, or to
“Insert the Leads into the OR Cable Connector” in the Clinician Trial Manual.
Securing the Trial Infinion 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.
Percutaneous Leads Directions for Use
91078744-02 REV A 18 of 27
Instructions for Use
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.
6. For temporary lead trials, refer to “Connecting to the Trial Stimulator” in the Precision Spinal Cord
Stimulator System Clinician Manual for instructions on connecting to the OR Cable assembly, or to
“Insert the Leads into the OR Cable Connector” in the Clinician Trial Manual.
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 space by slowly pulling the needle up
towards the proximal end of the lead while holding the lead in place.
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
Note: It is recommended to cut down prior to inserting the Entrada Needle. If cutting down after
inserting the Entrada Needle, ensure that the sheath is in place and do not damage the
sheath.
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
Percutaneous Leads Directions for Use
91078744-02 REV A 19 of 27
Percutaneous Leads Directions for Use
A) Stabilize lead in line with the slot
B) 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
Leads can be permanently anchored with a suture sleeve or with an anchor.
Note: When using the Infinion CX Lead, the anchor or suture sleeve must be loaded over the
distal end of the lead prior to inserting the Infinion CX Lead into the Entrada Needle. For the
Infinion 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 Scientific 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 fluoroscopy 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.
6. For Permanent Trials, proceed to “Tunneling the Lead or Lead Extension” on page 21.
7. For permanent IPG implantation:
Percutaneous Leads Directions for Use
91078744-02 REV A 20 of 27
Instructions for Use
• If using the Precision System, refer to “IPG Implantation” in the Precision Spinal Cord
Stimulator Clinician Manual.
• If using the Precision Spectra System, refer to “IPG Implantation” in the Precision Spectra
System Implantable Pulse Generator DFU.
• If using the Precision Novi System, refer to “IPG Implantation” in the Precision Novi System
Implantable Pulse Generator DFU.
Tunneling the Lead or Lead Extension
Note: If tunneling Infinion CX Lead(s), it is recommended to use the Long Tunneling Tool (35cm).
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.
5. Make a small incision at the desired exit site.
Percutaneous Leads Directions for Use
91078744-02 REV A 21 of 27
Percutaneous Leads Directions for Use
6. Create a subcutaneous tunnel between the midline 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 Infinion 16 lead, proceed to “Lead Connection to Splitter” on page
15 . Otherwise, proceed to “Connecting the Lead Extension” on page 23.
11.For Permanent IPG Implantation, if extensions are used, proceed to the instructions for “Connecting
the Lead Extension” on page 23.
12.For Permanent IPG Implantation, if splitters are used, proceed to the instructions for “Lead Connection
to Splitter” on page 15.
13.For Permanent IPG Implantation:
• If using the Precision System, refer to “Connecting to the IPG” in the Precision Spinal Cord
Stimulator System Clinician Manual.
Percutaneous Leads Directions for Use
91078744-02 REV A 22 of 27
Instructions for Use
• If using the Precision Spectra System, refer to “Connecting the Lead, Extension, Splitter, or
Connector to the IPG” in the Precision Spectra System Implantable Pulse Generator DFU.
• If using the Precision Novi System, refer to “Connecting the Lead, Extension, Splitter, or
Connector to the IPG” in the Precision Novi System Implantable Pulse Generator DFU.
Note: The following Codman Disposable Catheter Passers may be used in place of the Boston
Scientific tunneling tool except for the Infinion 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 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.
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 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.
Percutaneous Leads Directions for Use
91078744-02 REV A 23 of 27
Percutaneous Leads Directions for Use
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 Trial Stimulator” in the Precision Spinal Cord Stimulator System Clinician Manual or to “Insert the
Leads into the OR Cable Connector” in the Clinician Trial Manual.
8. For Permanent Implant, close the midline incision, and proceed as follows:
• If using the Precision System, refer to “Connecting the IPG” in the Precision Spinal Cord
Stimulator System Clinician Manual.
• If using the Precision Spectra System, refer to “Connecting the Lead, Extension, Splitter, or
Connector to the IPG” in the Precision Spectra System Implantable Pulse Generator DFU.
• If using the Precision Novi System, refer to “Connecting the Lead, Extension, Splitter, or
Connector to the IPG” in the Precision Novi System Implantable Pulse Generator DFU.
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: Percutaneous 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
“Percutaneous Lead Placement in the Epidural Space” on page 9.
4. 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 incision to expose the lead extension and connector.
2. Cut the lead extension at the connector. Do not cut the implanted lead.
Percutaneous Leads Directions for Use
91078744-02 REV A 24 of 27
Programming with the Infinion 16 Lead and Infinion CX Lead
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 as follows:
• If using the Precision System, refer to “IPG Implantation” in the Precision Spinal Cord
Stimulator System Clinician Manual.
• If using the Precision Spectra System, refer to “IPG Implantation” in the Precision Spectra
System Implantable Pulse Generator DFU.
• If using the Precision Novi System, refer to “IPG Implantation” in the Precision Novi System
Implantable Pulse Generator DFU.
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.
Programming with the Infinion 16 Lead and Infinion 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 Infinion 16 lead is used with the Splitter 2x8 and placed properly into the Precision Spectra IPG
ports (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 Infinion
16 lead and the unmarked splitter tail corresponds to contacts 9-16 of the Infinion 16 Lead.
When the Infinion CX Lead is placed properly in the Precision Spectra IPG ports (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 Infinion CX Lead and the tail with two
marker bands corresponds to contacts 9-16 of the Infinion CX Lead.
If using Bionic Navigator Software:
When the Infinion 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 Infinion 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 Infinion 16 lead (contacts 9-16) will correspond with contact 9-16
on the right side of the Bionic Navigator software display.
When the Infinion 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 Infinion 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 Infinion 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 Infinion 16 lead and Infinion 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 Bionic Navigator Software Guide.
Percutaneous Leads Directions for Use
91078744-02 REV A 25 of 27
Percutaneous Leads Directions for Use
Percutaneous Leads Directions for Use
91078744-02 REV A 26 of 27
Programming with the Infinion 16 Lead and Infinion CX Lead
This page intentionally left blank
Percutaneous Leads Directions for Use
91078744-02 REV A 27 of 27
Legal Manufacturer
Boston Scientific Neuromodulation
25155 Rye Canyon Loop
Valencia, CA 91355 USA
(866) 789-5899 in US and Canada
(661) 949-4000, (661) 949-4022 Fax
(866) 789-6364 TTY
www.bostonscientific.com
Email: [email protected]
AUS
Australian Sponsor
Address
Boston Scientific (Australia) Pty Ltd
PO Box 332
BOTANY
NSW 1455
Australia
Free Phone 1800 676 133
Free Fax 1800 836 666
EU Authorised
Representative
Boston Scientific Limited
Ballybrit Business Park
Galway, Ireland
T: +33 (0) 1 39 30 97 00
F: +33 (0) 1 39 30 97 99
© 2015 Boston Scientific Corporation
or its affiliates. All rights reserved.
91078744-02 REV A 2015-08
Was this manual useful for you? yes no
Thank you for your participation!

* Your assessment is very important for improving the work of artificial intelligence, which forms the content of this project

Download PDF

advertisement