Boston Scientific Precision Spinal Cord Stimulator System User manual

Precision™Spinal Cord
Stimulator System Clinician
Manual
SC-1110 Precision Implantable Pulse Generator
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 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-2316-xx Innion™ 16 xx cm 16 Contact Lead Kit
SC-2316-xxE Innion™ 16 xx cm 16 Contact Trial Lead Kit
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-3400-xx xxcm Splitter 2x8 Kit
SC-5210 or SC-5212 Precision Remote Control
SC-5305 Precision Base Station
SC-5312 Precision Charger
SC-8216-xx Artisan 2x8 Surgical Lead
SC-8120 xx Artisan 2x8 Surgical Lead
Note: xx = length (cm), xxE = length (cm) Trial Lead
CAUTION: Federal law restricts this device to sale,
distribution and use by or on the order of a physician.
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Table of Contents
SC-1110 Precision Implantable Pulse Generator
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 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-2316-xx Innion™ 16 xx cm 16 Contact Lead Kit
SC-2316-xxE Innion™ 16 xx cm 16 Contact Trial Lead Kit
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-3400-xx xxcm Splitter 2x8 Kit
SC-5210 or SC-5212 Precision Remote Control
SC-5305 Precision Base Station
SC-5312 Precision Charger
SC-8216-xx Artisan 2x8 Surgical Lead
SC-8120 xx Artisan 2x8 Surgical Lead
Note: xx = length (cm), xxE = length (cm) Trial Lead
Manual Overview ...........................................................................................7
Device and Product Description ..................................................................8
Implantable Pulse Generator .............................................................................................8
Leads .................................................................................................................................8
Lead Extension ..................................................................................................................9
Lead Splitter........................................................................................................................9
Indications for Use ......................................................................................10
Contraindications.............................................................................................................. 10
Safety Information........................................................................................ 11
Instructions for the Patient................................................................................................ 11
Warnings .......................................................................................................................... 11
Precautions ......................................................................................................................12
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Adverse Effects ................................................................................................................13
Instructions for the Physician ...........................................................................................14
Package Contents .......................................................................................15
IPG Kit .............................................................................................................................15
Percutaneous Permanent Lead Kit ..................................................................................15
Percutaneous Trial Lead Kit..............................................................................................15
Lead Extension Kit ...........................................................................................................15
2x4 Splitter Kit...................................................................................................................15
Surgical Paddle Lead Kit ..................................................................................................15
Innion™ 16 Contact Lead Kit.......................................................................................... 16
Innion™ 16 Contact Trial Lead Kit..................................................................................16
Splitter 2x8 Kit...................................................................................................................16
Innion™ 16 Lead and Splitter 2x8 Trial Kit......................................................................16
Innion™ 16 Lead and Splitter 2x8 Kit .............................................................................16
Sterilization, Handling, and Storage ..........................................................17
Sterilization ......................................................................................................................17
IPG Handling and Storage ...............................................................................................17
Lead, Lead Extension, and Splitter Handling and Storage ..............................................18
Pre-Op Instructions .....................................................................................19
Percutaneous Lead Placement in the Epidural Space .............................20
Lead Connection to Splitter ..............................................................................................21
Surgical Paddle Lead Placement in the Epidural Space ..........................23
Connecting the OR Cable Assembly .........................................................24
Intraoperative Stimulation Testing .............................................................25
Securing the Trial Lead ...............................................................................27
Permanent Lead Anchoring and Tunneling ...............................................28
Anchoring the Lead ..........................................................................................................28
Tunneling the Lead or Lead Extension ............................................................................29
Connecting the Lead Extension .......................................................................................30
Connecting to the Trial Stimulator .............................................................32
Removal of Trial Leads, Extensions, and Splitters ...................................33
Option A: Percutaneous Lead Removal after Temporary Trial ......................................... 33
Option B: Lead Extension Removal after Permanent Trial ..............................................33
Option C: Splitter Removal after Trial ............................................................................... 33
IPG Implantation ..........................................................................................34

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90607862-22 Rev A 5 of 303
Connecting to the IPG .................................................................................35
For Percutaneous Lead - Dual Lead Connection ............................................................35
For Innion™ Lead Connection........................................................................................ 35
For Percutaneous Lead - Single Lead Connection ..........................................................35
For Surgical Paddle Lead Connection .............................................................................35
Programming with the Innion™ 16 Lead......................................................................... 37
IPG Explant or Replacement ......................................................................38
Rechargeable Stimulator System ..............................................................39
IPG Battery Status ...........................................................................................................39
Charging Steps ................................................................................................................40
Patient Remote Control ....................................................................................................42
Device Linking .................................................................................................................46
Searching .........................................................................................................................47
Clinician Options............................................................................................................... 48
Specications and Technical Data .............................................................53
Materials ..........................................................................................................................53
Max Current Amp. per Electrode vs. Impedance .............................................................54
Registration Information..............................................................................57
Registering the Stimulator and Leads .............................................................................. 57
Technical Service ........................................................................................57
Labeling.........................................................................................................58
Limited Warranty - IPG ................................................................................61
Limited Warranty - Leads ............................................................................62
Limited Warranty - Externals.......................................................................63
Appendix .......................................................................................................64

Precision™ Spinal Cord Stimulator System Clinician Manual
Clinician Manual
90607862-22 Rev A 6 of 303
Copyright
© 2015 Boston Scientic Corporation or its afliates. All rights reserved.
These documents are the property of Boston Scientic Corporation and shall not be
reproduced, distributed, disclosed, or used for manufacture or sale of device without the
express written consent of Boston Scientic Corporation.
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
Artisan, Linear, BionicNavigator, and Precision are trademarks of Boston Scientic Corporation.
Velcro is a trademark of Velcro Industries, Manchester, New Hampshire. Other Brands and their
products are trademarks of their respective holders and should be noted as such.

Manual Overview
Clinician Manual
90607862-22 Rev A 7 of 303
Manual Overview
This manual provides basic information
for the trial, implantation, and operation of
the Boston Scientic Precision Spinal Cord
Stimulator (SCS) system.
General surgical guidelines are
presented in this manual for temporary
and permanent implantation of Boston
Scientic percutaneous leads, lead
extensions, splitters, surgical paddle leads,
and implantable pulse generator (IPG).
These products are designed to aid in the
management of chronic intractable pain.
This manual also provides an overview of
accessories for programming and charging
the IPG, clinical and surgical considerations,
storage and handling requirements, and
relevant precautions concerning an implanted
neurostimulator. Additional information on
system components and operation can be
found in the BionicNavigator Software Guide.

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Device and Product
Description
The Precision system consists of an
implantable pulse generator, temporary and
permanent percutaneous leads, surgical
paddle leads, and lead extensions, each
packaged as a separate kit. Single use
accessories and disposable tools are also
included in these kits.
Features of the Precision SCS System
include:
• Stimulation electrode eld navigation
• Sixteen independent current-controlled
electrodes
• Four programmable stimulation areas per
program; four possible
programs
• Long-life operation
• High-range parameter capability
• Small size
• Two-foot programming range
• This product contains no detectable latex
Implantable Pulse Generator
The Precision Implantable Pulse Generator
(IPG) system is intended to treat chronic
pain by electrically stimulating the spinal
cord. The multi-channel, multi-electrode
device capability provides exibility in
conjunction with ease of programming. A
rechargeable battery increases IPG longevity
and output capability while reducing size
and device replacement surgeries. The
IPG is controlled by a handheld Remote
Control, and can be engaged by a clinician
computer using proprietary BionicNavigator
software. Periodically, the IPG battery
requires replenishing with an RF charging
device provided separately in the Patient
Charging Kit.
Leads
The percutaneous and surgical paddle
leads function as a component of the
Precision SCS system by delivering electrical
stimulation to the nerve structures in the
dorsal aspect of the spinal cord, resulting in
an inhibition of pain sensation.
Surgical Paddle Lead
The 2x8 Surgical Paddle Lead is available
in lengths of 50 cm and 70 cm. The distal
(paddle) end of the lead has two columns of
eight evenly spaced planar electrodes. Each
electrode is 3x2 mm2in area. On the proximal
side, this lead employs 2 lead tails. The end
of each tail has eight evenly spaced contacts,
identical to the percutaneous leads. The right
tail of the Paddle Lead is laser-etched to
allow for ease of right and left identication.
Each tail can be inserted into an IPG or into a
lead extension.
Percutaneous Leads
Percutaneous Leads are available in lengths
of 30 cm, 50 cm, and 70 cm. Each 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. 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. Each contact is 3 mm in
length and is spaced 1 mm from the adjacent
contact. The 16 contact lead must be inserted
into a Splitter 2x8 which then connects to a

Device and Product Description
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90607862-22 Rev A 9 of 303
Precision™ IPG’s 8 contact ports or 8 contact
OR Cables.
Percutaneous Trial Leads
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 and paddle leads to the
Precision 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 3 mm 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 Precision IPG.
Lead Splitter
The 2x4 Splitters are designed to connect
multiple percutaneous leads to the Precision
IPG. The Linear leads may be inserted
into a splitter for a maximum of four Linear
leads per IPG. Four of the eight contacts
of each Linear lead will be activated. Two
congurations of 2x4 splitters 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. Only
one Innion™ 16 lead through one Splitter
2x8 can be connected to a Precision IPG.

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Indications for Use
The Precision Spinal Cord Stimulator System
(Precision System) is indicated as an aid in
the management of chronic intractable pain.
Contraindications
Patients contraindicated for permanent SCS
therapy are those who:
• are unable to operate the SCS system
• have failed trial stimulation by failing to
receive effective pain relief
• are poor surgical risks
• are pregnant

Safety Information
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90607862-22 Rev A 11 of 303
Safety Information
Instructions for the Patient
Warnings
Heat Due to Charging. Do not charge while
sleeping. This may result in a burn.While
charging, the Charger may become warm. It
should be handled with care. Failure to use
the Charger with either the Charging Belt or an
adhesive patch, as shown, may result in a burn.
If you experience pain or discomfort, cease
charging and contact Boston Scientic.
Magnetic Resonance Imaging (MRI). The
Precision SCS System is “MR Conditional”
when exposed to the magnetic resonance
imaging (MRI) environment under the specic
conditions dened in the supplemental manual
“1.5 Tesla MRI Guidelines to Physicians
for Patients with Precision Spinal Cord
Stimulator System”. It is important to read this
information in its entirety before conducting
or recommending an MRI examination on a
patient with a Precision SCS System. This
supplemental manual relates specically to the
use of a transmit/receive radio frequency (RF)
head coil of a 1.5 Tesla horizontal bore MRI
system for patients implanted with the
Boston Scientic Precision SCS System.
The 1.5 Tesla MRI Guidelines to Physicians
for Patients with Precision Spinal Cord
Stimulator System supplemental manual also
appears on the Boston Scientic website
(www.bostonscientic.com). MRI exposure
may result in dislodgement of implanted
components, heating of the neurostimulator,
damage to the device electronics and/or voltage
induction through the leads and Stimulator
causing an uncomfortable or “jolting” sensation.
Pediatric Use. The safety and effectiveness of
spinal cord stimulation has not been established
for pediatric use.
Diathermy. Shortwave, microwave and/or
therapeutic ultrasound diathermy should not be
used on SCS patients. The energy generated
by diathermy can be transferred through the
Stimulator system, causing tissue damage at
the lead site and resulting in severe injury or
death. The IPG, whether it is turned on or off,
may be damaged.
Implanted Stimulation Devices. Spinal cord
stimulators may interfere with the operation
of implanted sensing stimulators such as
pacemakers or cardioverter debrillators. The
effects of implanted stimulation devices on
neurostimulators is unknown.
Stimulator Damage. Burns may result if the
pulse generator case is ruptured or pierced and
patient tissue is exposed to battery chemicals.
Do not implant the device if the case is
damaged.
Postural Changes. Patients should be advised
that changes in posture or abrupt movements
may cause decreases, or uncomfortable or
painful increases in the perceived stimulation
level. Patients should be advised to turn down
the amplitude or turn off the IPG before making
posture changes. If unpleasant sensations
occur, the IPG should be turned off immediately.
Electromagnetic Interference. Strong
electromagnetic elds can potentially turn the
Stimulator off, or cause uncomfortable or jolting
stimulation. Patients should be counseled to
avoid or exercise care around:
• Theft detectors or security screeners
such as those used at entrances/

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exits of department stores, libraries,
and other public establishments, and/
or airport security screening devices. It
is recommended thatpatients request
assistance to bypass the device. If they
must proceed through the device, the
patient should turn off the Stimulator and
proceed with caution, ensuring to move
through the center of the screener as
quickly as possible.
• Power lines or power generators
• Electric steel furnaces and arc welders
• Large, magnetized stereo speakers
Precautions
Physician training is required.
Medical Devices/Therapies. The following
medical therapies or procedures may turn
stimulation off or may cause permanent
damage to the Stimulator, particularly if used in
close proximity to the device:
• lithotripsy
• electrocautery: Do not use monopolar
cautery. See “Instructions for the Physician”
page 14
• external debrillation
• radiation therapy
• ultrasonic scanning
• high-output ultrasound
If any of the above is required by medical
necessity, refer to “Instructions for the
Physician” page 14. Ultimately, however, the
device may require explantation as a result of
damage to the device.
Automobiles and Other Equipment.
Patients should not operate automobiles, other
motorized vehicles, or potentially dangerous
machinery/ equipment with therapeutic
stimulation switched on. Stimulation must be
turned off rst. Sudden stimulation changes, if
they occur, may distract patients from attentive
operation of the vehicle or equipment.
Post Operative. During the two weeks
following surgery, it is important to use extreme
care so that appropriate healing will secure the
implanted components and close the surgical
incisions:
• Do not lift objects of more than ve pounds.
• Do not engage in rigorous physical activity
such as twisting, bending, or climbing.
• If new leads were implanted, do not raise
your arms above your head.
Temporarily, there may be some pain in the
area of the implant as the incisions heal. If
discomfort continues beyond two weeks,
contact your physician.
If you notice excessive redness around the
wound areas during this time, contact your
physician to check for infection and administer
proper treatment. In rare cases, adverse tissue
reaction to implanted materials can occur during
this period.
Be sure to consult your physician before making
lifestyle changes due to decreases in pain.
Stimulator Location. Never attempt to change
the orientation or “ip” the Stimulator. Do
not “nger” or play with the Stimulator. If the
Stimulator ips over in your body, it cannot be
charged. If you know that the device has turned,
or if stimulation cannot be turned on after
charging, contact your physician to arrange an
evaluation of the system. In some cases, the
skin over your Stimulator may become very thin
over time. If this occurs, contact your physician.
Lead Location. In some instances a lead can
move from its original location, and stimulation

Safety Information
Clinician Manual
90607862-22 Rev A 13 of 303
at the intended pain site can be lost. If this
occurs, consult your physician who may able
to restore stimulation by reprogramming the
Stimulator in the clinic or repositioning the lead
during another operation.
Device Failure. Stimulators can fail at any
time due to random component failure, loss
of battery functionality, or lead breakage. If
the device stops working even after complete
charging (up to four hours), turn off the
Stimulator and contact your physician so that
the system can be evaluated.
Storage, Handling and Transport. Do not
expose the Remote Control or Charging
System components to excessively hot or cold
conditions. Do not leave the devices in your
car or outdoors for extended periods of time.
The sensitive electronics can be damaged
by temperature extremes, particularly high
heat. For proper operation, do not use the
Charger if the ambient temperature is above
35 °C (95 °F).
If the Remote Control or the Charging System
is to be stored for a period of time without
batteries, the storage temperature should not
exceed -20 to 60 °C (-4 to 140 °F).
Handle the system components and
accessories with care. Do not drop them or
submerge them in water. Although reliability
testing has been performed to ensure quality
manufacturing and performance, dropping the
devices on hard surfaces or in water, or other
rough handling, can permanently damage the
components. (See “Limited Warranty - IPG”
page 61.)
Component Disposal. Do not dispose of the
Remote Control or Charger in re. The battery
in these devices can explode in re. Dispose
of used batteries in accordance with local
regulations. The IPG should be explanted in
the case of cremation, and returned to Boston
Scientic. External devices to be disposed
of per local regulatory requirements. Please
contact your healthcare professional.
Remote Control, Charging System Cleaning.
The components can be cleaned using alcohol
or a mild detergent applied with a cloth or
tissue. Residue from soapy detergents should
be removed with a damp cloth. Do not use
abrasive cleansers for cleaning.
Cell Phones. While we do not anticipate any
interference with cell phones, the full effects
of interaction with cell phones are unknown
at this time. If there is a concern or a problem
is encountered, the physician should be
contacted.
Adverse Effects
Potential risks are involved with any surgery.
The possible risks of implanting a pulse
generator as part of a system to deliver spinal
cord stimulation include:
• Lead migration, resulting in undesirable
changes in stimulation and subsequent
reduction in pain relief.
• System failure, which can occur at any time
due to random failure(s) of the components
or the battery. These events, which may
include device failure, lead breakage,
hardware malfunctions, loose connections,
electrical shorts or open circuits and lead
insulation breaches, can result in ineffective
pain control.
• Tissue reaction to implanted materials
can occur. In some cases, the formation

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of reactive tissue around the lead in the
epidural space can result in delayed
onset of spinal cord compression and
neurological/sensory decit, including
paralysis. Time to onset is variable, possibly
ranging from weeks to years after implant.
• Skin erosion at the IPG site can occur over
time.
• Possible surgical procedural risks are:
temporary pain at the implant site, infection,
cerebrospinal uid (CSF) leakage and,
although rare, epidural hemorrhage,
seroma, hematoma and paralysis.
• External sources of electromagnetic
interference may cause the device to
malfunction and affect stimulation.
• Exposure to MRI can result in heating of
tissue, image artifacts, induced voltages
in the neurostimulator and/or leads, lead
dislodgement.
• Undesirable stimulation may occur over
time due to cellular changes in tissue
around the electrodes, changes in electrode
position, loose electrical connections and/or
lead failure.
• The patient may experience painful
electrical stimulation of the chest wall as a
result of stimulation of certain nerve roots
several weeks after surgery.
• Over time, the Stimulator may move from its
original position.
• Weakness, clumsiness, numbness or pain
below the level of implantation.
• Persistent pain at the IPG or lead site.
In any event, instruct the patient to contact their
physician to inform him/her.
Instructions for the Physician
Implanted Stimulation Devices. If such
implanted devices are indicated for the patient,
careful screening is required to determine if safe
results can be achieved before permanently
implementing concurrent electrical therapies.
Postural Changes. Depending on the activity
level of the patient, postural changes may
affect stimulation intensity. Instruct patients to
keep the Remote Control on hand at all times,
and ensure that they understand how to adjust
stimulation levels.
Medical Devices/Therapies. If the patient is
required to undergo lithotripsy, electrocautery,
external debrillation, radiation therapy,
ultrasonic scanning, or high-output ultrasound:
• Turn off stimulation at least ve minutes
before the procedure or application.
• All equipment, including ground plates and
paddles, must be used as far away from the
IPG as possible.
• Bipolar electrocautery is recommended. Do
not use monopolar electrocautery.
• Every effort should be taken to keep elds,
including current, radiation, or high-output
ultrasonic beams, away from the IPG.
• Equipment should be set to the lowest
energy setting clinically indicated.
• Instruct patients to conrm IPG functionality
following treatment by turning on the IPG
and gradually increasing stimulation to the
desired level.

Package Contents
Clinician Manual
90607862-22 Rev A 15 of 303
Package Contents
IPG Kit
(1) Precision Implantable Pulse Generator
(1) Hex Wrench
(1) Tunneling Tool Assembly
(1) IPG Pocket Template
(2) Port Plugs
(1) Device Registration Form/Temporary
Patient Identication Card
(1) Manual
Percutaneous Permanent
Lead Kit
(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 Identication 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) Manual
(1) Device Registration Form/Temporary
Patient Identication Car
Lead Extension Kit
(1) Lead Extension
(1) Hex Wrench
(1) Tunneling Tool Assembly
(1) Device Registration Form/Temporary
Patient Identication Card
(1) Manual
2x4 Splitter Kit
(1) Splitter
(1) Hex wrench
(1) Manual and Insert
(1) Device Registration Form/Temporary
Patient Identication Car
Surgical Paddle Lead Kit
(1) Paddle Lead
(4) Suture Sleeves
(2) OR Cable Assemblies
(2) Lead Position Labels—left and right
(non-sterile)
(1) Device Registration Form/Temporary
Patient Identication Card
(1) Manual

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Innion™ 16 Contact 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
(2) Lead Position Labels—left and right
(non-sterile)
(1) Manual
(1) Product Registration Form/Temporary
Patient Identication Card
(1) Steering Cap
Innion™ 16 Contact Trial
Lead Kit
(1) 16 Contact Percutaneous Lead with pre-
loaded Curved Stylet
(1) Suture Sleeve
(1) Insertion Needle
(2) Lead Position Labels—left and right
(non-sterile)
(1) Manual
(1) Product Registration Form/Temporary
Patient Identication Card
(1) Steering Cap
Splitter 2x8 Kit
(1) Splitter 2x8
(1) Torque Wrench
(1) Manual
(1) Product Registration Form/Temporary
Patient Identication Card
Innion™ 16 Lead and Splitter
2x8 Trial Kit
(1) Innion™ 16 Trial Lead Kit
(1) Splitter 2x8 Kit
Innion™ 16 Lead and Splitter
2x8 Kit
(1) Innion™ 16 Lead Kit
(1) Splitter 2x8 Kit

Sterilization, Handling, and Storage
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90607862-22 Rev A 17 of 303
Sterilization, Handling,
and Storage
Sterilization
All Precision system implantable and surgical
components are sterilized with ethylene
oxide.
Inspect the condition of the sterile package
before opening the package and using the
contents. Do not use the contents if the
package is broken or torn, or if contamination
is suspected because of a defective sterile
package seal.
• Do not use any component that shows
signs of damage.
• Do not resterilize the package or the
contents. Obtain a sterile package from
Boston Scientic.
• Do not use the product if the labeled “Use
By” date has passed.
• All components are for single use only. Do
not reuse.
• Do not use if package is opened or
damaged
• Do not use if labeling is incomplete or
illegible.
WARNING: Contents supplied STERILE
using an ethylene oxide (EO) process.
Do not use if sterile barrier is damaged. If
damage is found, call your Boston Scien-
tic representative.
For Single Use Only.
Do Not Reuse.
Do Not Resterilize.
Do not use if package is damaged.
For single patient use only. Do not reuse,
reprocess or resterilize. Reuse, reprocessing
or resterilization may compromise the
structural integrity of the device and/or lead
to device failure which, in turn, may result
in patient injury, illness or death. Reuse,
reprocessing or resterilization may also
create a risk of contamination of the device
and/or cause patient infection or cross-
infection, including, but not limited to, the
transmission of infectious disease(s) from
one patient to another. Contamination of the
device may lead to injury, illness or death of
the patient.
After use, dispose of product and packaging
in accordance with hospital, administrative
and/or local government policy.
IPG Handling and Storage
• Handle the IPG and all components with
care.
• Keep sharp instruments away from the
components.
• Do not use the IPG if it has been dropped
on a hard surface from a height of more
than one foot.
• Do not incinerate an IPG. Improper
disposal of the device could result in an
explosion. Devices should be explanted
in the case of cremation, and returned to
Boston Scientic Neuromodulation. An
explant kit is available.
Store the IPG between 0 °C and 45 °C
(32 °F and 113 °F). Devices should always
be kept in temperature regulated areas within
the acceptable temperature range. IPG
damage can occur at temperatures outside of
this range.

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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 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.

Pre-Op Instructions
Clinician Manual
90607862-22 Rev A 19 of 303
Pre-Op Instructions
1. Ensure that the IPG is fully charged prior to
the permanent implant procedure. The ap-
proximate location of the IPG is marked on
the IPG kit. Turn on the Charger and place
it over the IPG to begin charging.
2. Check that the sterile package is intact.
(See “Sterilization, Handling, and Storage”
page 17.)
3. Ensure that a Trial Stimulator is available
for use. Install a new battery in the Trial
Stimulator.
4. Be sure the Trial Stimulator and Remote
Control stimulation settings have been re-
set. (See “Device Linking” page 46.)
5. For trial procedures, ensure that a Patient
Trial Kit is available, proceed to “Percu-
taneous Lead Placement in the Epidural
Space” page 20.
6. For permanent IPG implantation, proceed
to “Removal of Trial Leads, Extensions,
and Splitters” page 33.

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Percutaneous Lead
Placement in the Epidural
Space
1. Position, prep and drape the patient in the
usual accepted manner. Inject a local an-
esthetic at the needle insertion site.
2. Under uoroscopic guidance, place the in-
sertion 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 nee-
dles 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 nee-
dle should be 45° or less. Steep angles in-
crease 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 inser-
tion needle and verify entry into the epi-
dural space using the standard technique.
4. OPTIONAL. Under uoroscopic guidance,
insert the lead blank through the insertion
needle and into the epidural space. Ad-
vance 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 nee-
dle. 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 resis-
tance 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 elec-
trode array is in the bevel of the insertion