Boston Scientific Precision 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
97035873-01
Content: MP97035873-01 REV B

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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.

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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
Precision System Clinical Summary ................................................................................................4
Safety Information..........................................................................................................................9
Instructions for the Patient................................................................................................................9
Warnings ..........................................................................................................................................9
Precautions ....................................................................................................................................10
Adverse Effects ..............................................................................................................................11
Instructions for the Physician .........................................................................................................12
Essential Performance ...................................................................................................................13
Telemetry Information ....................................................................................................................13
Package Contents .......................................................................................................................14
IPG Kit ...........................................................................................................................................14
Percutaneous Permanent Lead Kit ................................................................................................14
Percutaneous Trial Lead Kit............................................................................................................14
Lead Extension Kit .........................................................................................................................14
2x4 Splitter Kit.................................................................................................................................15
Surgical Paddle Lead Kit ...............................................................................................................15
Innion 16 Lead Kit.........................................................................................................................15
Innion 16 Trial Lead Kit .................................................................................................................15
Innion CX Lead Kit........................................................................................................................15
Innion CX Lead Trial Lead Kit .......................................................................................................16
Splitter 2x8 Kit.................................................................................................................................16
Innion 16 Trial Conguration Kit....................................................................................................16
Innion 16 Conguration 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
Innion CX Lead Placement in the Epidural Space with Entrada™ Needle...................................21
Lead Connection to Splitter ............................................................................................................26
Surgical Paddle Lead Placement in the Epidural Space .......................................................... 28
Connecting the OR Cable Assembly ......................................................................................... 29
Intraoperative Stimulation Testing .............................................................................................30
Securing the Trial Lead ............................................................................................................... 31

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Securing the Innion CX Trial Lead ...........................................................................................32
Permanent Lead Anchoring and Tunneling ............................................................................... 33
Anchoring the Lead ........................................................................................................................34
Tunneling the Lead or Lead Extension ..........................................................................................35
Connecting the Lead Extension .....................................................................................................37
Connecting to the Trial Stimulator ............................................................................................. 39
Removal of Trial Leads, Extensions, and Splitters ................................................................... 41
Option A: Percutaneous Lead Removal after Temporary Trial .......................................................41
Option B: Lead Extension Removal after Permanent Trial ............................................................41
Option C: Splitter Removal after Trial .............................................................................................41
IPG Implantation .......................................................................................................................... 42
Connecting to the IPG ................................................................................................................. 43
For Percutaneous Lead - Dual Lead Connection ..........................................................................43
For Innion™ 16 Lead Connection.................................................................................................43
For Innion CX Lead Connection....................................................................................................43
For Percutaneous Lead - Single Lead Connection ........................................................................43
For Surgical Paddle Lead Connection ...........................................................................................43
Programming with the Innion 16 Lead and Innion CX Lead........................................................45
IPG Explant or Replacement ......................................................................................................46
Rechargeable Stimulator System .............................................................................................. 47
IPG Battery Status .........................................................................................................................47
Charging Steps ..............................................................................................................................48
Patient Remote Control ..................................................................................................................50
Device Linking ...............................................................................................................................54
Searching .......................................................................................................................................55
Clinician Options.............................................................................................................................55
Remote Control Battery Life ...........................................................................................................60
Specications and Technical Data .............................................................................................61
Materials ........................................................................................................................................61
Max Current Amp. per Electrode vs. Impedance ...........................................................................62
Registration Information.............................................................................................................. 65
Registering the Stimulator and Leads ............................................................................................65
Technical Service ........................................................................................................................66
Electromagnetic Compatibility.................................................................................................... 67
EN 60601-1-2 Classication Information ........................................................................................67
Limited Warranty - IPG ................................................................................................................ 72
Limited Warranty - Leads ............................................................................................................ 73
Limited Warranty - Externals.......................................................................................................74
Patient Identication ...................................................................................................................75

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 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
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.

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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 Boston Scientic Precision Spinal Cord Stimulator (SCS) System is indicated as an aid in the
management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain
associated with the following:
• failed back surgery syndrome,
• Complex Regional Pain Syndrome (CRPS) Types I and II,
• intractable low back pain and leg pain,
• Diabetic Peripheral Neuropathy of the lower extremities,
• Radicular pain syndrome,
• Radiculopathies resulting in pain secondary to failed back syndrome or herniated disc,
• Epidural brosis,
• Degenerative disc disease (herniated disc pain refractory to conservative and surgical interventions),
• Arachnoiditis,
• Multiple back surgeries.
Note: CRPS I was previously referred to as Reex Sympathetic Dystrophy (RSD) and CRPS II was
previously referred to as causalgia.
Precision System Clinical Summary
Determination of the safety and effectiveness of the PRECISION System was based on available published
clinical studies for similar implanted spinal cord stimulation systems. The PRECISION System is similar to the
SCS systems reported in published literature in intended use, target patient population, technology, device
design, and output characteristics. Therefore, the clinical data from the published literature described below
represents evidence supporting the safety and effectiveness of the PRECISION System for the treatment
chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the
following: failed back surgery syndrome, intractable low back and leg pain.
Efcacy Evaluation
Three (3) clinical literature studies were used to support the effectiveness of the PRECISION System
(Ohnmeiss et al. 1996, Villavicencio et al. 2000, Hassenbusch SJ et al. 1995). The studies included a total
of 116 patients that were implanted with an SCS system. A total of approximately 3166 device months
of experience was depicted from the retrospective clinical evaluation. All three studies examined the
effectiveness of SCS on patients with chronic pain of the trunk and/or limbs including unilateral or bilateral
pain associated with the following: failed back surgery syndrome or intractable low back and leg pain. In
all studies, a totally implantable spinal cord stimulator was used in association with a percutaneous and/or
surgical lead. These studies provide the same diagnostic or therapeutic intervention for the same disease/
conditions and patient population as the PRECISION System.
The prospective study by Ohnmeiss et al. 1996, examined the long-term effectiveness of SCS in patients
with intractable leg pain. Forty patients were implanted with SCS systems and evaluated at 6 weeks,
12 months, and 24 months follow-up. Outcome measures included the VAS, pain drawings, medication use,
SIP (Sickness Impact Prole), isometric lower extremity testing, and patient questionnaires. An intent-to-treat
analysis was performed. After patients had SCS for 24 months, leg pain, pain when walking, standing pain,
pain’s effect on overall lifestyle, and the total analog scale scores were signicantly improved from baseline.
In this study, 25% of the implanted patients had greater than 50% improvement in pain rating.

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In addition, 3 patients from this study had their stimulators repositioned due to pain at the original location.
Three patients had reoperations to adjust lead position; 1 patient required 2 reoperations, 1 patient had
the device removed due to infection and later to have a new device implanted. A diabetic patient had skin
problems which required device removal; a new device was later implanted. Two patients had the device
removed due to unsatisfactory pain relief.
The prospective study performed by Villavicencio et al. 2000 included 41 patients with pain of various
etiologies. The majority of the patients, 24 (59%), had Failed Back Surgery Syndrome (FBSS), 7 (17%) had
Complex Regional Pain Syndrome (CRPS I and II), 4 (10%) had neuropathic pain syndrome, and 6 (15%)
were diagnosed as stroke or other. Patients underwent an initial trial period for SCS with temporary leads.
If the trial resulted in greater than 50% reduction in the patient’s pain, as measured by the VAS, the patient
was implanted with a SCS system. In this study, 27/41 patients, 66%, had permanent implants. All patients
were examined after 6 weeks. Pain measurements were assessed at 3-6 month intervals for the rst year and
annually thereafter. The median long-term follow-up was 34 months. A total of 24/27 (89%), reported greater
than 50% reduction in pain. Since the majority of the patients were treated for FBSS, this article supports the
use of SCS for the treatment of FBSS.
In this study, one patient required a revision because of electrode fracture. One patient required removal of
the system due to local infection. One patient required replacement of the IPG due to mechanical failure.
Overall, 16 of 27 (59%) patients required a total of 36 repositioning procedures.
A retrospective analysis performed by Hassenbusch SJ et al. 1995 included patients with chronic lower body
pain, predominately neuropathic pain and pain either midline lower back and/or unilateral or bilateral leg pain
treated over a 5 year period. The study was a comparison of SCS to spinal infusion of opioids. For patients
with radicular pain involving one leg with or without unilateral buttock pain, a trial of SCS was recommended
rst. For patients with midline back pain and /or bilateral leg pain, a trial of long-term spinal infusion was
recommended rst. If the patients failed screening with either of these modalities, the other was then tested.
If the treatment reduced the pain by 50%, the systems were internalized. A retrospective analysis of patients
with unilateral leg and/or buttock pain treated initially with SCS and bilateral leg or mainly low back pain
treated initially with spinal infusions of opioids was then done.
In this study, 42 patients were screened; 26 (62%) patients received spinal stimulation; 16 (38%) received
opioids via a spinal infusion pump. Five patients did not receive adequate pain relief with SCS; 3 (7%) of
these patients underwent trial spinal infusions and had effective pain relief. There were 4 (10%) patients who
underwent a trial of spinal infusion of opioid but did not receive adequate pain relief; these patients were not
tested with SCS. Pain severity was rated using a verbal digital pain scale: “On a scale of 0 to 10 where 0 is
no pain and 10 is the worst pain you could ever imagine, what is your pain now?” 16/26 patients (62%) had
greater than 50% pain relief with SCS. In this study, 2/16 (13%) had greater than 50% pain relief with opioids.
Mean follow-up was 2.1 ± 0.3 years. This analysis supports the use of SCS for intractable low back and
leg pain.
In this study, 7 (17%) patients suffered complications after implantation of the device; 5 (12%) patients
required repositioning of catheter type electrodes and 2 patients required revision of the stimulator generator.
Safety Evaluation
Eleven studies were identied based on the detailed inclusion/exclusion criteria to demonstrate the safety of
the PRECISION System. The studies included a total of 1056 patients that were trialed with SCS systems
and 880 patients that received implants. The table below depicts the number of patients, the number of
events, and the percentage of occurrences of each event compared to the total number of patients. It should
be noted that citations cover both IPG and RF systems. The clinical experience reported in the literature on
RF systems is relevant to determining the safety of totally implantable IPG systems.

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Table 1: Summary of Risks Identied in the Retrospective Clinical Studies
Risks # Patients With
Adverse Event
Intent-to-Treat Basis
N = 1056
Implanted Patient
Basis N = 880
Lead Migration 175 16.6% 19.9%
Infection 39 3.7% 4.4%
Epidural Hemorrhage 0 0% 0%
Seroma 0 0% 0%
Hematoma 1 0.1% 0.1%
Paralysis 0 0% 0%
CSF Leak 5 0.5% 0.6%
Over/Under Stimulation,
Ineffective Pain Control
46 4.4% 5.2%
Intermittent Stimulation 0 0% 0%
Pain Over Implant 16 1.5% 1.8%
Allergic Reaction 6 0.6% 0.7%
Skin Erosion 0 0% 0%
Lead Breakage 35 3.3% 4.0%
Hardware Malfunction 22 2.1% 2.5%
Loose Connection 0 0% 0%
Battery Failure 2 0.2% 0.2%
Other 45 4.3% 5.1%
Clinical Experience-Safety
Clinical data has been collected during a clinical study of the PRECISION System. As of January 15, 2004, 35
subjects were enrolled in the study at multiple sites and 26 subjects had a successful trial stimulation period
and were implanted with the PRECISION System. The follow-up period for the 26 implanted patients ranged
from 2 weeks to 6 months. The following major adverse events were reported.
Table 2: Clinical Experience Safety
Type Number of
Patients
Resolution
Lead Migration 1 Lead repositioning and subsequent replacement
Output malfunction 1 Device replaced
Infection 1 Infection treated
Pain 1 Lead explanted
Other minor adverse events reported by at least one patient included: receiver malfunction, skin irritation,
unpleasant stimulation, CSF leak, infection at implant site, lead migration, and OR cable malfunction. Two of
the subjects reported multiple events.

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References
Burchiel, K.J., V.C. Anderson, F.D. Brown, R.G. Fessler, W.A. Friedman, S. Pelofsky,
R.L. Weiner, J. Oakley,and D. Shatin. “Prospective, Multicenter Study of Spinal Cord Stimulation for Relief of
Chronic Back and Extremity Pain.” Spine, 21:2786-2793, 1996.
Hassenbusch, S.J., M. Stanton-Hicks, E.C. Covington. “Spinal cord stimulation verses spinal infusion for low
back and leg pain”. Acta Neurochirgica, 64:109-115, 1995.
Kemler, M.A., G.A.M. Barendse, M. Van Kleef, H.C.W. De Vet, C.P.M. Rijks, C.A. Furnee and F.A.J.M. Van
den Wilderberg. “Spinal Cord Stimulation in Patients with Chronic Reex Sympathetic Dystrophy.” New
England J of Medicine, 343: 618-24, 2000.
Kim S. H., R.R. Tasker, and M.Y. Oh. “Spinal Cord Stimulation for Nonspecic Limb Pain versus Neuropathic
Pain and Spontaneous versus Evoked Pain.” Neurosurgery, 48(5): 1056-1064, 2001.
Kumar, K., C. Toth, R. Nath, and P. Lang. “Epidural Spinal Cord Stimulation for Treatment of Chronic Pain-
Some Predictors of Success. A 15 year experience.” Surg Neurol, 50: 110-120, 1998.
Lang, P. “The Treatment of Chronic Pain by Epidural Spinal Cord Stimulation.” AXON, 18(4): 71-73, 1997.
Ohnmeiss, D., R. Rashbaum, M. Bogdanffy. Prospective Outcome Evaluation of Spinal Cord Stimulation in
Patients With Intractable Leg Pain. Spine, 21:1344 1351, 1996.
Rainov, N.G., V. Heidecke, and W. Burkert. “Short Test-Period Spinal Cord Stimulation for Failed Back
Surgery Syndrome.” Minim Invasive Neurosurg, 39(2):41-44, 1996.
Segal, R., B. Stacey, T. Rudy, S. Basser, J. Markham. “Spinal Cord Stimulation Revisited.” Neurological
Research, 20:391-396, 1998.
Spieglemann, R. and W.A. Friedman. “Spinal Cord Stimulation: A Contemporary Series.” Neurosurg 28:65-71,
1991.
Villavicencio, A.T., J.C. Leveque, L. Rubin, K. Bulsara, and J.P. Gorecki. “Laminectomy versus percutaneous
electrode placement for spinal cord stimulation.” Neurosurgery, 46:399-406, 2000.
Subperception Therapy – Clinical Summary
Determination of the safety and effectiveness of the Boston Scientic Spinal Cord Stimulator (SCS) Systems
for subperception therapy was based on a prospective, randomized, multicenter, crossover study with the
primary endpoint of responder rate (proportion of subjects with 50% or greater improvement in overall pain) at
3 month post-device activation. A crossover design provided a within-subject comparison between the supra-
perception and subperception settings.
The primary objective of this study was to demonstrate sustained clinically signicant pain relief in patients
with chronic pain when using the Boston Scientic SCS Systems at subperception amplitude.
Of the 197 subjects that provided consent to participate in the study, 136 were randomized to either receive
subperception followed by supra-perception settings or vice versa for 90 days post-activation. The study
cohort was comprised of subjects who have been treated successfully with paresthesia-inducing stimulation
for at least six months.
Efcacy Outcomes
The study successfully met its primary effectiveness endpoint, demonstrating that the proportion of overall
pain responders at 90 days post-activation with subperception settings is non-inferior compared to supra-
perception settings at a statistically signicant level (p < 0.001). The study also successfully demonstrated
non-inferiority in the Per Protocol group indicating the robustness of the study.

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At the end of the crossover period, subjects were asked to choose between supra-perception and
subperception settings. Of the 70 subjects included in the primary effectivenss cohort, 53 subjects (76%)
chose subperception whereas only 17 (24%) chose supra-perception as their preferred treatment settings.
Additionally, 40 subjects (57%) preferred to keep both the stimulation treatments if given the option.
Safety Outcomes
A total of 27 adverse events were reported among 20 subjects across the entire study experience. Of the
27 adverse events, 12 were serious adverse events (SAEs) and 15 nonserious adverse events. All serious
adverse events were unrelated to the study-device and/or study-procedure. There were no unanticipated
events.
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
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). Patients implanted with the Precision SCS system should not be
subjected to MRI. 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. If using therapy that does not produce a
sensation (subperception), postural changes are less likely to affect the patient.
Electromagnetic Interference. Strong electromagnetic elds can potentially turn the Stimulator off, cause
temporary unpredictable changes in stimulation, or interfere with the Remote Control communication.
Patients should be counseled to avoid or exercise care around the following:
• Theft detectors, tag deactivators and RFID devices, such as those used at department stores,
libraries, and other public establishments. The patient should proceed with caution, ensuring to move
through the center of the detector as quickly as possible.
• Security screeners, such as those used in Airport Security or at entrances to government buildings,
including hand-held scanners. The patient should request assistance to bypass the device. If the
patient must pass through the security screener, they should move quickly through the device staying
as far from the physical device as allowable.
• Power lines or power generators.
• Electric steel furnaces and arc welders.
• Large magnetized stereo speakers.
• Strong magnets.
• Automobiles or other motorized vehicles using a LoJack system or other anti-theft systems that can
broadcast a radio frequency (RF) signal. The high energy elds produced by these systems may
interfere with the operation of the Remote Control and its ability to control stimulation.

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• Other sources of electromagnetic disturbance, such as RF transmitters at television or radio
broadcast stations, Amateur Radio or Citizens Band radio transceivers, or Family Radio Service band
transceivers.
Note: When in close proximity, equipment that generates strong electromagnetic elds might cause
unintended stimulation or interfere with wireless communication even if they comply with International
Special Committee on Radio Interference (CISPR) requirements.
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 12
• 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 12 .
Ultimately, however, the device may require explantation as a result of damage to the device.
Subperception Therapy. Subperception stimulation has been demonstrated to be safe and effective in
patients who have been treated successfully with conventional, paresthesia-inducing stimulation for at least
six months. Full stimulation parameter ranges and options for both paresthesia-based and subperception
therapy are available for clinician’s use throughout the patient’s experience and treatment with SCS.
Automobiles and Other Equipment. Patients using therapy that generates paresthesia should not operate
motorized vehicles such as automobiles or potentially dangerous machinery and equipment with the
stimulation on. Stimulation must be turned off rst in such cases. For these patients, any sudden stimulation
changes may distract patients from proper operation of the vehicle, machinery, or equipment. For therapy that
does not generate paresthesia (i.e., subperception therapy) it is less likely that sudden stimulation changes
resulting in distraction could occur while having stimulation on when operating moving vehicle, machinery,
and 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 2.5 kilograms (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.

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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 therapy at the intended
pain site can be lost. If this occurs, consult your physician who may able to restore therapy 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.
Operating Temperature. The operating temperature of the Trial Stimulator and Remote Control is 5–40 °C
(41–104 °F). For proper operation, do not use the Charger if the ambient temperature is above 35 °C (95 °F).
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.
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 “” on page 68.)
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, and External Trial Stimulator 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. Do not clean any of the
accessories while they are directly or indirectly connected to a power outlet.
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 E󰀨ects
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.

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• 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.
• Changes in blood glucose levels in response to any adverse event.
In any event, instruct the patient to contact their physician to inform him/her.
Note: Diabetic patients may have increased risks of infection, problems healing around the surgical site, and
complications common to any surgical procedure. The severity of any surgical complication may be
greater in diabetic patients, particularly those with inadequate pre-operative glycemic control.
Instructions for the Physician
WARNING: Use in diabetic patients - Surgical complications and adverse events may be more
frequent and severe in diabetic patients. The following additional considerations should be made for
diabetic patients including:
• A preoperative risk assessment should be performed for patients with diabetes who are at high risk
for ischemic heart disease, those with autonomic neuropathy or renal failure, and patients with a
Hemoglobin A1C (HbA1c) ≥ 8% (64 mmol/mol).
• Monitor the patient’s blood glucose levels in the perioperative period and instruct the patient to
continue to monitor levels as they may uctuate as a response to surgery or to complications.
Implanting physicians and/or anesthesiologists should consult practice guidelines for the
intraoperative management of diabetic patients.
• Closely monitor patient for signs of infection, delayed wound healing, or cerebrospinal uid (CSF)
leakage as the severity of these complications may be greater in diabetic patients.
WARNING: Stimulation modes. Only paresthesia-based stimulation mode has been evaluated for
effectiveness in the diabetic peripheral neuropathy (DPN) population.
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. If using therapy that does not produce a sensation (subperception), postural
changes are less likely to affect the patient.

Safety Information
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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.
Essential Performance
Failure of the external electrical components will not result in an unacceptable risk to the user.
Telemetry Information
Frequency Band: 119 – 131 kHz
Modulation type: FSK
Effective Radiated Power: 0.4 mW (-4 dBm) maximum
Magnetic Field Strength (at 3 m distance): 94 μA/m

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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 Card
Lead Extension Kit
(1) Lead Extension
(1) Hex Wrench
(1) Tunneling Tool Assembly
(1) Device Registration Form/Temporary Patient Identication Card
(1) Manual

Package Contents
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2x4 Splitter Kit
(1) Splitter
(1) Hex wrench
(1) Manual and Insert
(1) Device Registration Form/Temporary Patient Identication Card
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
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

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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 Trial Conguration Kit
(1) Innion™ 16 Trial Lead Kit
(1) 2x8 Splitter Kit
Innion 16 Conguration Kit
(1) Innion™ 16 Lead Kit
(1) 2x8 Splitter Kit