Boston Scientific Precision SCS System Series Manual

CAUTION: Federal law restricts this device to sale,
distribution and use by or on the order of a physician.
Precision™ Spinal Cord
Stimulator System
Clinician Manual
Directions for Use
91173656-02
Content: 92070399 REV B
en defr nl
Directions for Use
Mode d’emploi
Gebrauchsanweisung
Gebruiksaanwijzing
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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.
Additional Information
For other device-specic information not included in this manual or labeling symbols, refer to
the appropriate DFU as listed on your Reference Guide.
Product Model Numbers
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 xxcm 16 Contact Lead Kit
SC-2316-xxE Innion™ 16 xxcm 16 Contact Trial Lead Kit
SC-2317-xx Innion CX xxcm 16 Contact Lead Kit
SC-2317-xxE Innion CX xxcm 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
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Model Description
SC-3304-xx D4 Splitter 2x4
SC-3354-xx W4 Splitter 2x4
SC-3400-xx xxcm Splitter 2x8 Kit
SC-5210 Precision Remote Control
SC-5212 Precision Remote Control
SC-5305 Precision Base Station
SC-5312 Precision Charger
SC-8120-xx Artisan 2x8 Surgical Lead
SC-8216-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
Package Contents .......................................................................................10
IPG Kit ............................................................................................................................. 10
Percutaneous Permanent Lead Kit .................................................................................. 10
Percutaneous Trial Lead Kit .............................................................................................. 10
Lead Extension Kit ........................................................................................................... 11
2x4 Splitter Kit ................................................................................................................... 11
Surgical Paddle Lead Kit .................................................................................................. 11
Innion™ 16 Lead Kit ....................................................................................................... 11
Innion™ 16 Trial Lead Kit ................................................................................................ 12
Innion CX Lead Kit ..........................................................................................................12
Innion CX Lead Trial Lead Kit .........................................................................................12
Splitter 2x8 Kit ...................................................................................................................12
Innion™ 16 Lead and Splitter 2x8 Trial Kit ...................................................................... 12
Innion™ 16 Lead and Splitter 2x8 Kit ............................................................................. 13
Sterilization, Handling, and Storage ..........................................................14
Sterilization ...................................................................................................................... 14
IPG Handling and Storage ............................................................................................... 14
Lead, Lead Extension, and Splitter Handling and Storage ..............................................15
Pre-Op Instructions .....................................................................................16
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Percutaneous Lead Placement in the Epidural Space .............................17
Innion CX Lead Placement in the Epidural Space with Entrada Needle .........................19
Lead Connection to Splitter .............................................................................................. 24
Surgical Paddle Lead Placement in the Epidural Space ..........................27
Connecting the OR Cable Assembly .........................................................28
Intraoperative Stimulation Testing .............................................................30
Securing the Trial Lead ...............................................................................32
Securing the Innion CX Trial Lead............................................................33
Permanent Lead Anchoring and Tunneling ...............................................34
Anchoring the Lead ..........................................................................................................35
Tunneling the Lead or Lead Extension ............................................................................36
Connecting the Lead Extension ....................................................................................... 39
Connecting to the Trial Stimulator .............................................................41
Removal of Trial Leads, Extensions, and Splitters ...................................43
Option A: Percutaneous Lead Removal after Temporary Trial .........................................43
Option B: Lead Extension Removal after Permanent Trial ..............................................43
Option C: Splitter Removal after Trial ...............................................................................44
IPG Implantation ..........................................................................................45
Connecting to the IPG .................................................................................46
For Percutaneous Lead - Dual Lead Connection ............................................................46
For Innion™ 16 Lead Connection ...................................................................................46
For Innion CX Lead Connection ......................................................................................46
For Percutaneous Lead - Single Lead Connection .......................................................... 46
For Surgical Paddle Lead Connection .............................................................................47
Programming with the Innion™ 16 Lead and Innion CX Lead ......................................49
IPG Explant or Replacement ......................................................................50
Rechargeable Stimulator System ..............................................................51
IPG Battery Status ...........................................................................................................51
Charging Steps ................................................................................................................52
Patient Remote Control .................................................................................................... 54
Device Linking ................................................................................................................. 60
Searching .........................................................................................................................62
Clinician Options ............................................................................................................... 62
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Specications and Technical Data .............................................................68
Materials .......................................................................................................................... 68
Max Current Amp. per Electrode vs. Impedance ............................................................. 69
Registration Information..............................................................................73
Registering the Stimulator and Leads ..............................................................................73
Technical Service ........................................................................................74
EN 60601-1-2 Classication Information....................................................75
Limited Warranty - IPG ................................................................................76
Limited Warranty - Leads ............................................................................78
Limited Warranty - Externals.......................................................................80
Appendix .......................................................................................................81
Contact Information .....................................................................................88
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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.
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Device and Product Description
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Percutaneous Leads
The eight-contact 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 16 contact percutaneous
lead (Innion™ 16 Lead and Innion CX 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 Innion 16 lead must be inserted into a Splitter 2x8 which
then connects to a 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
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Safety Information
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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 supple mental 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.
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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/exits of department
stores, libraries, and other public establishments, and/or airport security screening devices. It
is recommended that patients 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” on
page 9.
• 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” on
page 9. 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.
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Safety Information
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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 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” on page 76)
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.
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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 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.
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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.
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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
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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
Innion™ 16 Lead Kit
(1) 16 Contact Lead with pre-loaded Curved Stylet
(1) Stylet Ring with a Curved and a Straight Stylet
(1) Straight Stylet
(4) Suture Sleeves
(1) Insertion Needle
(1) Lead blank
(2) Lead Position Labels—left and right (non-sterile)
(1) Manual
(1) Product Registration Form/Temporary Patient Identication Card
(1) Steering Cap
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Innion™ 16 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
Innion CX Lead Kit
(1) 16 Contact Percutaneous Innion CX Lead with pre-loaded Curved Stylet
(2) Suture Sleeves
(2) Lead Position Labels—left and right (non-sterile)
(1) Manual
(1) Product Registration Form/Temporary Patient Identication Card
(1) Steering Cap
Innion CX Lead Trial Lead Kit
(1) 16 Contact Percutaneous Innion CX Lead with pre-loaded Curved Stylet
(2) Suture Sleeves
(2) Lead Position Labels—left and right (non-sterile)
(1) 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
Boston Scientific Confidential. Unauthorized use is prohibited.
Production
92070399 B.2
Precision Clinician Manual N EU Entrada
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