Boston Scientific Precision Spinal Cord Stimulator System Instructions for use

Precision™ Spinal
Cord Stimulator
System
Clinician Manual
CAUTION: Federal law restricts this device to sale,
distribution and use by or on the order of a physician.
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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 respective holders.
Product Models and Description
Model Description
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

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Table of Contents
Manual Overview ...........................................................................................1
Device and Product Description ..................................................................2
Implantable Pulse Generator .............................................................................................2
Leads .................................................................................................................................2
Lead Extension ..................................................................................................................3
Lead Splitter ........................................................................................................................3
Indications for Use ........................................................................................4
Contraindications ................................................................................................................4
Safety Information..........................................................................................5
Instructions for the Patient ..................................................................................................5
Warnings ............................................................................................................................5
Precautions ........................................................................................................................ 6
Adverse Effects ..................................................................................................................8
Instructions for the Physician ............................................................................................. 9
Essential Performance .......................................................................................................9
Telemetry Information ........................................................................................................9
Package Contents .......................................................................................10
IPG Kit ............................................................................................................................. 10
Percutaneous Permanent Lead Kit .................................................................................. 10
Percutaneous Trial Lead Kit .............................................................................................. 10
Lead Extension Kit ........................................................................................................... 10
2x4 Splitter Kit ...................................................................................................................10
Surgical Paddle Lead Kit .................................................................................................. 10
Innion™ 16 Contact Lead Kit .......................................................................................... 11
Innion™ 16 Contact Trial Lead Kit .................................................................................. 11
Splitter 2x8 Kit ................................................................................................................... 11
Innion™ 16 Lead and Splitter 2x8 Trial Kit ...................................................................... 11
Innion™ 16 Lead and Splitter 2x8 Kit ............................................................................. 11
Sterilization, Handling, and Storage ..........................................................12
Sterilization ...................................................................................................................... 12
IPG Handling and Storage ............................................................................................... 12
Lead, Lead Extension, and Splitter Handling and Storage ..............................................13
Pre-Op Instructions .....................................................................................14
Percutaneous Lead Placement in the Epidural Space .............................15
Lead Connection to Splitter .............................................................................................. 16

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Surgical Paddle Lead Placement in the Epidural Space ..........................18
Connecting the OR Cable Assembly .........................................................19
Intraoperative Stimulation Testing .............................................................20
Securing the Trial Lead ...............................................................................22
Permanent Lead Anchoring and Tunneling ...............................................23
Anchoring the Lead ..........................................................................................................23
Tunneling the Lead or Lead Extension ............................................................................24
Connecting the Lead Extension ....................................................................................... 25
Connecting to the Trial Stimulator..............................................................27
Removal of Trial Leads, Extensions, and Splitters ...................................28
Option A: Percutaneous Lead Removal after Temporary Trial .........................................28
Option B: Lead Extension Removal after Permanent Trial ..............................................28
Option C: Splitter Removal after Trial ...............................................................................28
IPG Implantation ..........................................................................................29
Connecting to the IPG .................................................................................30
For Percutaneous Lead - Dual Lead Connection ............................................................ 30
For Innion™ Lead Connection ........................................................................................30
For Percutaneous Lead - Single Lead Connection .......................................................... 30
For Surgical Paddle Lead Connection .............................................................................30
Programming with the Innion™ 16 Lead .........................................................................32
IPG Explant or Replacement ......................................................................33
Rechargeable Stimulator System ..............................................................34
IPG Battery Status ...........................................................................................................34
Charging Steps ................................................................................................................35
Patient Remote Control .................................................................................................... 37
Device Linking ................................................................................................................. 42
Searching .........................................................................................................................43
Clinician Options ............................................................................................................... 43
Specications and Technical Data .............................................................50
Materials .......................................................................................................................... 50
Max Current Amp. per Electrode vs. Impedance ............................................................. 51
Registration Information..............................................................................54
Registering the Stimulator and Leads ..............................................................................54
Technical Service ........................................................................................54
Labeling.........................................................................................................55

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Electromagnetic Compatibility.................................................................... 57
EN 60601-1-2 Classication Information .......................................................................... 57
Limited Warranty - IPG ................................................................................61
Limited Warranty - Leads ............................................................................62
Limited Warranty - Externals.......................................................................63
Appendix .......................................................................................................64

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Manual Overview
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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 Bionic Navigator™ 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 Bionic Navigator
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 mm2 in 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

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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