Boston Scientific Neuromodulation PSC1110W Precision SCS System Implantable Pulse Generator User Manual II Patient Trial

Boston Scientific Neuromodulation Corporation Precision SCS System Implantable Pulse Generator II Patient Trial

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Patient Trial Guide

Patient Trial Handbook

CAUTION:

Federal law restricts this device to sale, distribution and use by or on the order of a physician.

MP9055185 Rev A

DRAFT

Patient Trial Handbook

translation of all or part of the contents of this document without the express written permission of

Advanced Bionics Corporation is strictly forbidden by the provisions of the law of March 11th,

1957.

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noted as such.

Table of Contents

iii

Table of Contents

1 Introduction .......................................................................1

What is Spinal Cord Stimulation? ........................................... 2

Caretaking During the Trial ..................................................... 3

How to Use This Manual During the Trial ................................ 6

2 Overview: The Trial Journal ...........................................7

Pain Profile ............................................................................ 7

The Journal ............................................................................ 8

3 Using the Medical Equipment .........................................9

The Trial Stimulator System ...................................................... 9

Taking Care of Your Trial Equipment ..................................... 11

The Trial Stimulator ............................................................... 12

The Remote Control .............................................................. 14

Basic Operation .................................................................. 15

Stimulation On and Off ........................................................ 17

The Level Screen .................................................................. 17

Stimulation Level Control ....................................................... 20

Selecting Areas for Level Control ........................................... 21

Programs ............................................................................. 22

Patient Trial Handbook

Selecting and Activating Programs ........................................ 23

Saving Program Changes ..................................................... 24

Battery Information ............................................................... 26

4 Safety Information ..........................................................31

Indications for Use ............................................................... 31

Precision System Clinical Summary ........................................ 31

Contraindications ................................................................. 40

Warnings ............................................................................ 41

Precautions .......................................................................... 43

Adverse Effects ..................................................................... 47

5 Help ..................................................................................51

Stimulation ........................................................................... 51

Remote Control Display ........................................................ 53

Accessories ......................................................................... 55

Contacting Advanced Bionics ............................................... 56

Glossary ...........................................................................57

Index..................................................................................61

1Introduction

Welcome to the “Trial Phase” of the Advanced Bionics® Precision™ pain management

program. You’re about to test a pain treatment therapy that could result in a dramatic change

in your life and your lifestyle. The trial you’ve agreed to participate in is intended to give

you and your physician a chance to evaluate spinal cord stimulation (SCS) as an appropriate

and effective long-term therapy option for your chronic pain.

At the end of the trial period (approximately one week) you and your physician will meet to

discuss your experience with spinal cord stimulation. The doctor will also want to explore

your feelings about a permanent SCS implant so that, together, both of you can determine

whether long-term treatment with spinal cord stimulation is an appropriate option for you.

To prepare yourself for this important decision, you may want to spend at least some of the

trial period carefully evaluating spinal cord stimulation.

Patient Trial Handbook

What is Spinal Cord Stimulation?

Most pain signals travel from the source problem or injury area to nerve pathways to the

spine, then up the spine and to the brain. SCS uses electrical stimulation of the spinal cord to

block the perception of those signals. To apply the stimulation, a small electrical pulse

generator is connected to one or two wires, called leads, which are placed along your spinal

cord. The stimulator, internal or external, sends pulses of a low electrical current to a series

of metal contacts, called electrodes, located at the end of the lead(s). The “feeling” produced

by this stimulation is a light sensation called paresthesia. Thousands of SCS patients

consider paresthesia not only a pleasant substitute feeling, but also an effective and welcome

relief from pain.

It’s important to understand that spinal cord stimulation cannot cure pain or eliminate its

cause. It does, however, provide control of and relief from certain types of pain over the area

where the paresthesia is felt. Spinal cord stimulation is a treatment choice designed to

provide you with the most effective pain relief over the widest pain area possible. When that

goal is reached with the Precision™ system, you should experience good to excellent relief

from chronic pain.

Introduction

Caretaking During the Trial

To speed-up your recovery following the surgery, your physician might require bed rest for

the first several hours after the surgery; administer antibiotics; schedule a mid-trial follow-

up visit; and limit your physical activity, including driving.

CAUTION: If your doctor approves of you driving during the trial, always turn off the Trial

Stimulator before getting behind the wheel. Please ask for specific instructions about what

you may do and should not do during the trial, and follow all instructions carefully!

Patient Trial Handbook

Be aware that some changes in posture can cause a decrease or (at times) an uncomfortable

increase in the strength of the stimulation. Keep the Remote Control with you at all times so

that you can make adjustments quickly if necessary.

You can help the recovery process by:

• Keeping your incision dry. Be sure

you understand instructions about

cleaning the incision and sponge-

bathing. You must not bathe or

shower during the trial.

• Checking the wound occasionally

for signs of redness or the presence

of fluid.

• Notifying your physician’s office if

you develop a fever, or if you

experience increased pain at the incision site.

• Limiting most physical activity during the trial.

Introduction

During sleep, bathing or for comfort, turn off the Trial Stimulator, remove it from the

pocket, and disconnect the leads (see “The Trial Stimulator” on page 12 for information on

disconnecting the leads).

The position and stability of your leads is a vitally important part of the trial experience.

Remember that, when they were placed along your spine, the leads were specifically located

according to where you felt stimulation covering your pain. You want the leads to stay in

place! So, to prevent them from moving:

• Do not lift objects of more than 5 pounds.

• Do not engage in rigorous activity such as twisting, bending or climbing.

• Do not raise your arms above your head.

• Do not pull or jiggle the leads.

Again, call your doctor if you have any questions about an activity that you’re not sure is

appropriate for you during the trial.

Patient Trial Handbook

How to Use This Manual During the Trial

You will probably want to refer to this manual often during the trial period. For that reason,

the content is arranged in the order you are most likely to need it.

Overview: The Trial Journal. This section describes the SCS Trial Journal which is

included at the back of this manual. The journal is made up of a brief questionnaire, a simple

chart, and a stimulation activity log. Start your journal the first full day following surgery.

Using the Medical Equipment. Turn to this section when you’re ready to learn about the

many ways available for managing stimulation using the Remote Control unit to program

the Trial Stimulator. Depending upon the instructions you receive from your doctor you may

not need all of the information here during the trial, but it may help you in the future.

2 Overview: The Trial Journal

All trials or tryouts require careful record keeping of times or scores, and your SCS trial is

no exception. In order for you and your doctor to decide to move on to the next step—a

permanent implant— you’ll both need a way to review the details of each of your SCS trial

days. The easiest way to do that is with the help of a journal. Your journal, which can be

found at the back of this manual, consists of the following:

Pain Profile

You may think of the Pain Profile as a way to make a starting point for this trial and for the

journal. The simple questions you answer here will establish a detailed, personal description

of your pain condition. The profile includes a simple graph called a Visual Analog Scale

(VAS), commonly used to measure the before-and-after pain levels of SCS trial patients.

You may have completed a VAS before in your doctor’s office or at a clinic. Once your VAS

Patient Trial Handbook

score is marked, it becomes an important tool for determining your progress at the end of the

trial.

The Journal

Seven log pages are included in your journal. We suggest that you begin keeping the log

starting with the first full day following your surgery. An explanation of the columns

follows:

• Activity: Please name the activity whether it’s getting out of bed, washing the

dishes, or walking the dog.

• Time: Fill in the approximate time (starting, during or ending) of the activity.

• VAS: Use this column to enter a Visual Analog Scale pain score for what your

pain level was during the activity. The VAS score is a number between zero (0)

and ten (10), where 10 is the worst pain imaginable and 0 is no pain. Rate the

pain level you had while doing the activity.

• STIM ON (Program No.) or STIM OFF: Indicate if stimulation was on or off

during the activity. If you know which program you were using, write the

program number (1, 2, 3 or 4).

3 Using the Medical Equipment

The Trial Stimulator System

The Trial Stimulator is a temporary

external spinal cord stimulator that

is connected to the lead(s) placed

along the spinal cord. You will use

this external system to test how

effective stimulation is in relieving

your pain.

Patient Trial Handbook

The Trial System includes:

• Trial Stimulator

•Lead(s)—An implantable wire that sends stimulation pulses to the spinal cord.

You may have one or two leads.

•Remote Control—A small battery powered computer used to adjust stimulation.

•Cable(s)—Thin plastic-coated wire(s) used to attach the Trial Stimulator to the

lead.

•Velcro® Belt—A waist wrap/pocket for wearing the Trial Stimulator.

Using the Medical Equipment

Taking Care of Your Trial Equipment

All of the items that were sent home with you

from the hospital are important to your trial

success, so please follow the instructions

listed.

• Handle the Trial Stimulator and the

Remote Control with care. These items are

well-designed, quality-tested electronic

components. However, they can be

damaged if they’re dropped on a hard

surface.

• Never submerge the Trial Stimulator or the

Remote Control in water, or leave them

outside in the rain, extreme heat, or

extreme cold. Avoid all sources of water

that can come into contact with the Remote Control and the Trial Stimulator.

• Always turn off the Trial Stimulator, remove it from the belt pocket, and disconnect and

secure the leads before taking a sponge bath.

Patient Trial Handbook

• Carry your Temporary Patient Identification card (given to you by your healthcare

provider) throughout the trial.

The Trial Stimulator

To turn stimulation on or off, press the E button

on the stimulator or on the Remote Control.

When the stimulator is on, the indicator light will

blink.

CAUTION: Always turn the stimulator off before

connecting or disconnecting your lead(s).

Disconnecting the Trial Stimulator

The Trial Stimulator has connectors for both left

and right leads, and a third connector for a patch

electrode. Whether you have one or two leads,

your doctor probably placed identifying labels on

them before connecting them to matching plugs

on the stimulator. These labels are intended to

Using the Medical Equipment

make it as easy as possible for you to connect the leads properly. Remember to check the

label(s) each time you need to reconnect the leads.

Note: If you were given a patch electrode for stimulation, an extra one is provided in case the

adhesive wears out. When connecting a new patch electrode, be sure to plug it into the

connector securely.

Patient Trial Handbook

The Remote Control

The Remote Control unit is your direct link to

choices available for tailoring spinal cord

stimulation to suit your comfort and convenience

requirements. Keep the Remote Control with you at

all times.

The Remote Control is used to:

• Turn stimulation on and off

• Change stimulation levels

• Activate or save new programs

Each button on the remote activates one of the

stimulation functions which are described on the

following pages. If you have a successful trial and

later receive the permanent Precision stimulator,

you’ll learn about additional Remote Control

features that are not described here.

Program Button

Area Button

Stimulation On/Off Button

Up/Activate

Down/Save

Using the Medical Equipment

Basic Operation

When it is not being used, the Remote Control sets

itself in a “sleep” or idle mode and the display screen

is blank. When you press any button except E

(stimulation on/off) during this sleep mode, the

Remote Control will “wake up” and display the

screen shown on the right. After you unlock the

buttons by pressing D, the remote will immediately

look for your implant and then connect with it,

allowing you to make adjustments to your

stimulation. When you are finished using it (no

buttons are being pressed), the remote will return to

the sleep mode within a minute or so.

Keys Locked

Press To

Unlock

Patient Trial Handbook

Good communication between the stimulator and the

Remote Control is very important. For that reason,

you will sometimes see the message “Connecting...”

while you are using the Remote Control because it is

always checking for the Trial Stimulator.

Note: If there is a problem communicating with the

stimulator, the message “No Response” will appear

on the Remote Control screen. See “Help” on

page 51 for more information.

The Remote Control unit is your direct link to

choices available for tailoring spinal cord stimulation

to suit your comfort and convenience requirements.

Keep the Remote Control with you at all times.

Using the Medical Equipment

Stimulation On and Off

The Remote Control uses a “dedicated” stimulation

on/off switch.You may press E at any time—even

during the remote’s sleep or idle mode—to turn

stimulation on or off. The remote will briefly display

a message notifying you of the on or off status.

The Level Screen

Whenever stimulation is turned on, or after the

Remote Control is awakened from sleep/idle mode,

the remote display defaults to the Level screen.

When you press the S or T button from this display,

you’re able to increase or decrease the stimulation

strength, or level, of all of your pain areas at once (if

your Trial Stimulator was programmed to treat more

Patient Trial Handbook

than one area). To learn about adjusting the stimulation of individual areas, please see

“Selecting Areas for Level Control” on page 21.

The Level screen also displays a bar graphic in the

upper right corner to indicate the battery charge level

of your stimulator. The graphic is very easy to

understand: Three filled-in bars means that the

battery is fully-charged. As the battery strength

wears down, depending on your stimulation settings

and usage, the bars will “empty” accordingly. For

complete information on maintaining the battery for

uninterrupted delivery of the therapy prescribed for

you, see “Battery Information” on page 26.

Full

Low

Using the Medical Equipment

Note: • Remember, the Level screen will remain on the display for approximately one minute if you

don’t press a button to perform an action with the Remote Control. After a minute, the

remote will go into idle mode and the display will go blank.

•Multiple area control is available only if your

system has been programmed to deliver stimula-

tion to separate areas. If you do not have sepa-

rate area control (for example, left leg vs. right

leg) but feel that separate control might improve

your therapy, contact your health professional to

determine what is possible.

Patient Trial Handbook

Stimulation Level Control

Occasionally, you may see one of the accompanying

messages on the Remote Control screen while

changing the stimulation level. These displays, and a

“beep” from the Remote Control, alert you that you

have reached either a maximum or a minimum level:

The bar replacing the up arrow means that you have

reached the maximum allowable level and can only

decrease the stimulation setting. The bar replacing

the down arrow means that you have reached the

minimum level and can only increase the stimulation

setting.

Using the Medical Equipment

Selecting Areas for Level Control

Your Remote Control may have as many as four

therapy areas stored for your use. Each area will have

a name or a number (1 through 4) which was

assigned during your programming at the clinic.The

stimulation level for each of these areas is controlled

from an individual “area level” screen. To change the

stimulation strength of a single area:

1. From the main Level screen, press the Cbutton

as many times as necessary to cycle through your

programmed area Level screens.

Note: Button presses will move from one area to the next and will eventually return you to the Level

screen.

2. When the named or numbered area that you want to adjust is shown on the screen, press

S (increase) or T (decrease) to change the stimulation level for that area.

When you’ve finished making your change, the Remote Control will return to the Level

screen.

Patient Trial Handbook

Programs

A stimulation program may provide paresthesia to cover a single pain area, or up to four

areas, depending on how the program was set up by your clinician. Your Remote Control

can store up to four programs—numbered 1 through 4—for you to select and activate at any

time. Often, the programs will have certain differences in the settings to allow you to vary

your stimulation in several ways. You may have been encouraged to try using specific

programs for different circumstances, or different body positions, or different times in your

daily routine. Programs and their flexibility give you and your healthcare professional a way

to continually “fine tune” your therapy.

Using the Medical Equipment

Selecting and Activating Programs

1. Press the Dbutton from the Level screen to go to

the Program screen.

From the Program screen, each additional

Dbutton press cycles you through the program

numbers. The black highlight box shows where

you are in the cycle. Pressing Dfrom program 4

returns you to the Level screen.

2. Press Duntil the program you want is

highlighted, then press S to activate the program.

Patient Trial Handbook

Note: • You might not have four programs saved in your

Remote Control. Empty program slots will have

an X beside the program number. If you try to

activate an empty program, nothing will happen

and you will hear an alert beep.

•An underline beneath a program number means

that program was the most recently activated or

saved (see below) program.

Once you have selected and activated a program, the

Remote Control will return to the Level screen. Use

the S or T to adjust the stimulation level of the

program, if you wish.

Saving Program Changes

If you do make a stimulation level adjustment and

decide that you prefer it to the original setting, you

can save the new level and make it a permanent part

of the program:

Using the Medical Equipment

1. After making a change to a program, press D

from any screen to return to the Program screen.

2. From the Program screen, press Das many times

as necessary to select the active program; that is,

the program that is currently running and the one

you’ve just changed.

3. With the active program selected, press T to save

the change in the remote’s memory.

The Remote Control will first ask you to .confirm

that you want to “overwrite” the program; press the

appropriate button.

If you confirm the change (Yes, or D), the program

will be updated and saved. If you decide not to make

a permanent change, pressing Cwill return you to

the Program screen.

Patient Trial Handbook

You may also save a program change as a completely new program if an empty program slot

(X) is available: Simply select the empty slot using D and press T. After saving the new

program, the Remote Control will return to the Level screen.

Battery Information

When the Remote Control batteries are at a low

power level, the message shown here will be

displayed. It is a good idea to replace the batteries at

this point. If you continue to use the remote without

replacing the batteries, you will eventually see the

message “Replace Remote Battery.” Do not ignore

the message to replace the batteries!

When you press Dfrom the Remote Battery Low

screen, the Remote Control will make a check of the

Trial Stimulator’s battery status also.

• If the Trial Stimulator’s battery is full/OK, the Remote Control will return to the

Level screen without displaying a message.

Using the Medical Equipment

• If the stimulator’s battery is low, this

message will be displayed.

• If the stimulator’s battery is very low, this

message will be displayed.

Respond to all battery messages as soon as possible

to prevent an interruption of stimulation therapy

during your trial period.

Patient Trial Handbook

Remote Control Battery Replacement

1. On the rear of the remote, push in slightly and

slide down the battery compartment cover.

2. Remove the old batteries.

3. Place the three new AAA batteries in the slots,

matching the positive (+) and negative (-)

markings.

4. Align the cover on the case and slide the cover

into position until it snaps closed.

The Remote Control will connect to your Trial Stimulator in approximately 30 seconds.

Trial Stimulator Battery Replacement

It’s not likely to happen over the short term of your SCS trial period, but your Trial

Stimulator battery may drain to a very low level. If this happens, install a new battery right

away.

Using the Medical Equipment

Be sure that stimulation is off (the indicator light is not blinking) before opening the Trial

Stimulator’s battery compartment. Replace the old battery with a 6-volt battery (lithium

Duracell 28L) available at most drug and convenience stores.

1. On the rear of the unit, press down on

the ridged area of the battery

compartment cover and push the cover

off of the case.

2. Remove the old battery and place the

new battery in the compartment

matching the positive (+) and negative

(-) markings.

3. Close the compartment by sliding the

cover on the stimulator case in the

opposite direction.

Patient Trial Handbook

When the new battery is installed, you will see this

screen on the Remote Control display. Don’t be

concerned by the “Action Failed” message; simply

press D to continue.

When D is pressed, the Remote Control will go into

idle mode (the display will be blank):

• To turn on stimulation immediately, press E.

• To perform any other action, first press any key to “wake up” the Remote

Control, then press D to unlock the remote’s buttons.

0000008000

4 Safety Information

Indications for Use

The Advanced Bionics Precision™ Spinal Cord Stimulator System (Precision 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, intractable low back pain and leg pain.

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

Patient Trial Handbook

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.

Efficacy Evaluation

Three (3) clinical literature studies were used to support the effectiveness of the

PRECISION System (Ohnmeiss et al. 1996, Villavincencio et al. 2000, Hassenbach 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

Safety Information

included the VAS, pain drawings, medication use, SIP (Sickness Impact Profile), 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 significantly

improved from baseline. In this study, 25% of the implanted patients had greater than 50%

improvement in pain rating.

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

Patient Trial Handbook

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 first 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 opiods. For patients with radicular pain involving

one leg with or without unilateral buttock pain, a trial of SCS was recommended first. For

patients with midline back pain and /or bilateral leg pain, a trial of long-term spinal infusion

was recommended first. 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

Safety Information

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.

Patient Trial Handbook

Safety Evaluation

Eleven studies were identified 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.

Table 1: Summary of Risks Identified 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%

Safety Information

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

CSF Leak 5 0.5% 0.6%

Over/Under Stimula-

tion, Ineffective Pain

Control

46 4.4% 5.2%

Intermittent Stimula-

tion

00%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%

Patient Trial Handbook

a successful trial stimulation period and were implanted with the PRECISION™ System.

The follow-up period for the 26 implanted patients ranged from two weeks to six months.

The following major adverse events were reported.

Table 2: Clinical Experience Safety

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.

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

Safety Information

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 Reflex 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 Nonspecific 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.

Patient Trial Handbook

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.

Contraindications

Patients contraindicated for permanent SCS therapy are those who:

• are unable to operate the SCS system

• have failed trial stimulation by failing to receive effective pain relief

• are poor surgical risks

• are pregnant

Safety Information

Warnings

Magnetic Resonance Imaging (MRI). You should not be exposed to Magnetic Resonance

Imaging (MRI). Exposure to this diagnostic technology may result in dislodgement of your

IPG or leads, heating of the IPG, severe damage to the IPG electronics and/or increased

voltage through the leads or IPG which can cause an uncomfortable or “jolting” sensation.

Pediatric Use. The safety and effectiveness of spinal cord stimulation has not been

established for pediatric use.

Diathermy. As an SCS patient, you should not have any form of diathermy either as

treatment for a medical condition or as part of a surgical procedure. The high energy and

heat generated by diathermy can be transferred through the leads, causing tissue damage at

the lead site and, possibly, severe injury or death. The IPG, whether it is turned on or off,

may be damaged.

Cardiac Pacemakers. Spinal cord stimulators may interfere with the operation of

implanted sensing stimulators, such as pacemakers and implantable cardiac defibrillators

(ICDs). Be sure your physicians are aware of your spinal cord stimulator before going

forward with other implantable device therapies so that medical decisions can be made and

appropriate safety measures taken.

Patient Trial Handbook

Implant 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.

Posture. Changes in posture or abrupt movements may cause decreases, or uncomfortable

or painful increases in the perceived stimulation level. Keep the remote control with you at

all times, and turn the stimulation down or off before making posture changes. If unpleasant

sensations occur, the stimulation should be turned off immediately.

Electromagnetic Interference. Strong electromagnetic fields can potentially turn the

stimulator off, or cause uncomfortable or jolting stimulation. 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 you request assistance to bypass the device.

If you must proceed through the device, turn off the stimulator and proceed with

caution, and move through the center of the screener as quickly as possible.

• Power lines or power generators

• Electric steel furnaces and arc welder

• Large magnetized stereo speakers

Safety Information

As you approach these devices you may become aware of changing stimulation levels. In

rare instances, you could experience an increase in stimulation level to the point that the

sensation is uncomfortably strong or possibly “jolting.” If this happens, turn off the External

Trial Stimulator. If the stimulator suddenly turns off by itself, first move away from the area.

Next, check the stimulation status with the Remote Control by pressing the power button

and observing the screen.

Always be aware of your surroundings, particularly near theft detectors/security screeners.

Ask for assistance to go around these devices if you feel at all uncomfortable.

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 implant, particularly if used in close

proximity to the device:

• lithotripsy — high-output sound or shock waves often used to treat gall stones

and kidney stones

Patient Trial Handbook

• electrocautery — the use of a heated electric probe to stop bleeding during

surgery

• external defibrillation — the use of electrically charged paddles to restart the

heart in an emergency

• radiation therapy — ionizing energy commonly used to treat cancer

• ultrasonic scanning — very high frequency sound waves used to produce images

of internal organs or tissue for diagnostic purposes

• high-output ultrasound — high frequency sound waves which may be applied as

physical therapy to treat certain bone/muscle injuries, or for muscle stimulation,

or to improve blood flow

Before having procedures, medical therapies, or diagnostics, have your healthcare

professional call our Customer Service department at (866) 360-4747 for proper

instructions.

Automobiles and Other Equipment. Do not operate an automobile, other motorized

vehicle, or any potentially dangerous machinery/equipment with therapeutic stimulation

switched on. Turn off stimulation first. Sudden stimulation changes, if they occur, may

distract you from attentive operation of the vehicle or equipment.

Safety Information

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 exercise or attempt to move heavy objects, and avoid deep bending and stretching.

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.

Implant Location. Never attempt to change the orientation or “flip” the implant. Do not

“finger” or play with the implant. If the implant flips 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 implant 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

Patient Trial Handbook

may be able to restore stimulation by reprogramming the implant in the clinic or

repositioning the lead during another operation.

Device Failure. Implants 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 implant and contact your physician so that the

system can be evaluated.

Storage. 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, be careful that the storage temperature does not exceed -20–60

°C (-4–140 °F).

Handling. Handle the system components and accessories with care. Do not drop them or

submerge them in water. Avoid all sources of water which can come into contact with the

Trial Stimulator and the Remote Control. 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.

Safety Information

Component Disposal. Do not dispose of the Remote Control or Charger in fire. The battery

in these devices can explode in fire. Dispose of used batteries in accordance with local

regulations. The IPG should be explanted in the case of cremation, and returned to

Advanced Bionics.

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 don’t anticipate any interference with cell phones, the full effects of

interaction with cell phones are unknown at this time.

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:

• The lead(s) which deliver stimulation may move from their original implanted

location, resulting in undesireable changes in stimulation and subsequent

reduction in pain relief.

Patient Trial Handbook

• System failure, which can occur at any time due to random failure(s) of the

components or the battery. These events, which may include battery leakage,

device failure, lead breakage, hardware malfunctions, loose connections,

electrical shorts or open circuits and lead insulation breaches, can result in

ineffective pain control.

• Your body may react negatively to the materials used to manufacture the

stimulator or the leads. You may notice redness, warmth or swelling of the

implant area.

• The skin over your implant may become thin and increasingly tender over time.

A seroma may be formed.

• The most common surgical procedural risks are temporary pain at the implant

site and infection. However, since the leads are placed in the fluid surrounding

your spinal cord, there is a small risk that spinal fluid may leak from the lead

insertion site following surgery. Very rarely, you may develop an internal blood

clot (hematoma) or blister (seroma); or you may experience brain hemorrhage or

paralysis. Your spinal cord may become compressed.

• External sources of electromagnetic interference may cause the device to

malfunction and affect stimulation.

Safety Information

• MRI. Exposure to magnetic resonance imaging (MRI) can result in noticeable

heat near the implant or the leads; may distort or destroy the image needed for

diagnosis; and may produce enough electromagnetic interference (EMI) to erase

the implant programming, destroy the leads, or cause the leads to move from

their intended location.

• 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.

• You may experience painful electrical stimulation of your chest wall as a result

of stimulation of certain nerve roots several weeks after surgery.

• Over time, your implant may move from its original position.

• You may experience weakness, clumsiness, numbness or pain below the level of

implantation.

• You may experience persistent pain at the IPG or lead site.

Patient Trial Handbook

5Help

Stimulation

No Stimulation

1. When stimulating, the Trial Stimulator indicator

light will blink. If it is not blinking, toggle the E

button on the Trial Stimulator or the Remote

Control. When the Remote Control receives

confirmation from the Trial Stimulator, it will

display “Stimulation On.”

2. When the indicator light is blinking and you still

do not feel stimulation:

Patient Trial Handbook

a. Check to make sure the lead cable is properly connected to the stimulator. Turn

off stimulation before adjusting the cables, and then turn it back on.

b. If you were provided a skin patch electrode, check that it is properly secured to

your skin. Make sure to turn off stimulation first, and then turn it back on.

c. Try increasing (S) the stimulation level. If this does not bring on stimulation,

decrease the level (T) to the original setting.

3. When the indicator light is not blinking and you do not feel stimulation, replace the Trial

Stimulator battery.

4. Call your physician’s office if the above steps do not solve the problem.

Stimulation Increases or Decreases on Its Own

1. Stimulation can change depending on body position (lying down, standing or bending).

2. Always keep the Remote Control with you, so that you can adjust your stimulation

levels as needed.

Stimulation Coverage is in a Different Area Than at the Doctor’s Office

1. If stimulation moves, and you did not activate a different program, you should call your

doctor. It is possible that the leads may have moved.

Help

Remote Control Display

“Remote Battery Low” on the Display

The batteries in your Remote Control need to be

replaced with three fresh AAA batteries (refer to

“Remote Control Battery Replacement” on page 28).

Patient Trial Handbook

“No Response” on the Display

When the Remote Control displays “No Response,”

there is a communication problem between the

remote and the stimulator probably caused by a weak

battery. Press the Dbutton. If the Remote Control is

still not able to communicate with your stimulator,

the “No Response” message will appear again; press

D again. If the remote connects with the stimulator,

you will be returned to the display you were using

before the problem began. If the problem cannot be

corrected, the Remote Control will go into sleep

mode. Replace the Trial Stimulator battery, reactivate the Remote Control (see page 30), and

try the action again.

Occasionally, telemetry problems happen because the Remote Control cannot find the

stimulator because of orientation or interference. Move the remote closer and then press the

Dbutton.

Call our Customer Service Department at (866) 360-4747 if the problem continues.

Help

“Action Failed” on the Display

If the Remote Control displays the error screen

shown at right, try to make a note of the numbers (the

error code) on the top line. Then press D, wait a few

seconds, and try the action again.

Please call our Customer Service Department at your

earliest convenience to report the error code.

Note: The remote will go to idle mode when D is pressed,

or within fifteen seconds if D is not pressed.

A special “Action Failed” error message is displayed by the Remote Control when the Trial

Stimulator battery is changed. Please see page 30 for information on how to proceed if you

have to change the stimulator battery.

Accessories

Washing the Velcro® Belt

1. Wash the belt with mild soap and warm water.

Patient Trial Handbook

Contacting Advanced Bionics

If you have any other questions, or need to contact Advanced Bionics for any reason, you

may do so in any of the following ways:

• Customer Service Phone: (866) 360-4747

• Customer Service Fax: (661) 362-1503

• Address: Advanced Bionics® Corporation

Pain Management Division

Mann Biomedical Park

25129 Rye Canyon Loop

Valencia CA 91355

Glossary

ADVERSE EFFECT.

Undesirable result.

AMPLITUDE.

The measure-of-strength of

delivered stimulation. (See Level.).

AREA.

A location on the body such as right

leg or left leg where stimulation will

occur.

Area Button icon.

CABLE.

Thin plastic coated wire(s)

connecting the exposed portion of

temporary lead(s) to the Trial Stimulator.

CARDIAC PACEMAKER.

A small

implantable device used to control the

rhythm of the heart.

DIATHERMY.

A therapeutic procedure used

to heat body tissue by high-frequency

electromagnetic currents.

DISPLAY.

The Remote Control screen.

ELECTRICAL PULSE GENERATOR.

Also

called an implantable pulse generator

(IPG); used to send electrical pulses to the

spinal cord or other parts of the body.

ELECTRICAL STIMULATION.

The energy

created by a pulse generator.

ELECTROMAGNETIC INTERFERENCE

(EMI).

Electromagnetic signals that

interfere with a variety of electrical

signals including spinal cord stimulation.

EXTERNAL TRIAL STIMULATOR (ETS).

An electrical pulse generator used during

the Trial Phase of SCS therapy evaluation.

Patient System Handbook

IDLE MODE.

A time-out period when the

Remote Control is not being used. See

also Sleep Mode.

IMPLANT.

Small electrical pulse generator

used to control stimulation.

INCISION.

Small surgical cut or opening in

the skin.

INDICATOR.

A signal light used on the Trial

Stimulator and the IPG Charger.

LABELS.

Adhesive tags (2-R) (1-L) placed

on the trial lead cables to show where to

attach the cables to the Trial Stimulator .

LEAD MIGRATION.

The movement of a

lead away from the spinal cord.

LEAD.

A surgical wire that sends electrical

stimulation pulses from a pulse generator

to the spinal cord.

LEVEL.

Term used on the Remote Control

screen to identify the amplitude or

strength of stimulation pulses.

MRI.

Magnetic Resonance Imaging; the use

of a nuclear magnetic resonance

spectrometer to produce electronic images

of tissues and organs.

PAIN PROFILE.

A record or documentation

of pain locations, occurrences, and

intensity. A pain "chart" for determining

therapy.

PARESTHESIA.

Sensation produced by

electrical stimulation.

Glossary

PATCH ELECTRODE.

An adhesive patch

placed on the skin and attached to the Trial

Stimulator only when trial leads are not

used.

PATIENT IDENTIFICATION CARD.

wallet size card that lists the patient and

physician names, and IPG model and

serial number.

PERMANENT IMPLANT.

A stimulator

system, pulse generator and leads,

implanted in the body and maintained by a

pulse generator battery Charging System.

PRECAUTION.

Generally, situations that you

should be aware of in order to avoid

potentially uncomfortable stimulation

sensations and/or damage to your

stimulation system.

PROGRAM.

Combination of one or more

stimulation areas.

Program Button icon.

REMOTE CONTROL.

A battery powered

hand-held computer used to adjust

stimulation.

SAVE.

The Remote Control button command

used to store a newly created or modified

stimulation program.

SLEEP MODE.

A time-out period when the

Remote Control is not being used. See

also Idle Mode.

SPINAL CORD STIMULATION (SCS).

method of applying electrical pulses to the

spinal cord to block/mask pain signals to

the brain.

Patient System Handbook

STIMULATION.

When used as a therapy for

pain, an artificially applied, low-level,

pulsating electrical "shock" felt as a

tingling or pulsating sensation in the area

of pain and perceived enough to reduce

the awareness of pain.

STIMULATION COVERAGE.

Area on the

body where stimulation occurs. (See

Area.)

Stimulation On/Off Button icon.

SYSTEM FAILURE.

Inability of stimulator

system to deliver stimulation therapy.

TRIAL SCREENING.

Temporary evaluation

of electrical stimulation of the spinal cord.

TRIAL JOURNAL.

Questionnaire, chart and

activity log used to record information

during the Trial Phase.

TRIAL STIMULATOR SYSTEM.

Precision

system components used during a limited

time to evaluate SCS therapy. The Trial

Stimulator System consists of an External

Trial Stimulator (ETS), temporary or

permanent lead(s), lead cable(s), the

Remote Control, and a Velcro Belt.

VA S .

Visual Analog Scale. Numerical scale/

graph used to chart before-and-after pain

levels included in the Pain Profile.

WARNING.

Potential hazards that you must

be aware of to avoid serious situations that

may cause injury or death.

Index

cable ............................................. 10, 52

diathermy ..................................... 41, 57

indicator ............................................. 12

label .................................................... 13

level .................................................... 20

MRI .................................................... 49

paresthesia ............................................2

Patient Identification card ..................12

Trial Journal .........................................7

VAS ..................................................7, 8

Patient Trial Handbook

The following is federal government communications regulation information about the Pre-

cision™ System.

This device complies with part 15 of the FCC Rules. Operation is subject to the following

two conditions: (1) This device may not cause harmful interference, and (2) This device

must accept any interference received including interference that may cause undesired oper-

ation.

The Precision™ System components should only be serviced by Advanced Bionics. Do not

attempt to open or repair any of the components. Unauthorized opening of or attempts to

repair the components will void the warranty.

Changes of modifications to this product not authorized by Advanced Bionics Corporation

could void the FCC Certification and negate your authority to operate this product.

Patient Trial Handbook

Boston Scientific Neuromodulation PSC1110W Precision SCS System Implantable Pulse Generator User Manual II Patient Trial

Boston Scientific Neuromodulation Corporation Precision SCS System Implantable Pulse Generator II Patient Trial

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