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

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Document ID	463397
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Document Description	Patient Trial Guide
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Document Type	User Manual
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Date Submitted	2004-08-26 00:00:00
Date Available	2004-12-13 00:00:00
Creation Date	2004-06-04 20:57:23
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Document Title	II Patient Trial.book
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MP9055185 Rev A
Federal law restricts this device to sale, distribution and use by or on the order of a physician.
CAUTION:
Patient Trial Handbook
DRAFT
ii
Velcro® is a registered mark of Velcro Industries, Manchester, New Hampshire. Other brands and
their products are trademarks or registered trademarks of their respective holders and should be
noted as such.
Registered trademarks
Advanced Bionics Corporation reserves the right to modify, without prior notice, information
relating to its products in order to improve their reliability or operating capacity.
Guarantees
©2004 by Advanced Bionics Corporation. All Rights Reserved. Any copying, reproduction or
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.
Copyright
Patient Trial Handbook
3
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
Using the Medical Equipment .........................................9
Pain Profile ............................................................................ 7
The Journal ............................................................................ 8
Overview: The Trial Journal ...........................................7
What is Spinal Cord Stimulation? ........................................... 2
Caretaking During the Trial ..................................................... 3
How to Use This Manual During the Trial ................................ 6
Introduction .......................................................................1
Table of Contents
iii
Table of Contents
iv
Selecting and Activating Programs ........................................ 23
Saving Program Changes ..................................................... 24
Battery Information ............................................................... 26
Index..................................................................................61
Glossary ...........................................................................57
Stimulation ........................................................................... 51
Remote Control Display ........................................................ 53
Accessories ......................................................................... 55
Contacting Advanced Bionics ............................................... 56
Help ..................................................................................51
Indications for Use ............................................................... 31
Precision System Clinical Summary ........................................ 31
Contraindications ................................................................. 40
Warnings ............................................................................ 41
Precautions .......................................................................... 43
Adverse Effects ..................................................................... 47
Safety Information ..........................................................31
Patient Trial Handbook
Introduction
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.
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.
2
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.
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.
Patient Trial Handbook
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!
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 followup visit; and limit your physical activity, including driving.
Introduction
4
•
•
•
•
Keeping your incision dry. Be sure
you understand instructions about
cleaning the incision and spongebathing. 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.
You can help the recovery process by:
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.
Patient Trial Handbook
• 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.
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:
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).
Introduction
6
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.
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.
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.
Patient Trial Handbook
Overview: The Trial Journal
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
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:
8
•
•
•
•
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).
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:
score is marked, it becomes an important tool for determining your progress at the end of the
trial.
Patient Trial Handbook
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.
10
•
•
•
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.
Trial Stimulator
•
The Trial System includes:
Patient Trial Handbook
11
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.
Using the Medical Equipment
12
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
CAUTION: Always turn the stimulator off before
connecting or disconnecting your lead(s).
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.
• Carry your Temporary Patient Identification card (given to you by your healthcare
provider) throughout the trial.
Patient Trial Handbook
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.
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.
13
Using the Medical Equipment
14
• 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.
The Remote Control is used to:
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.
Patient Trial Handbook
Up/Activate
Area Button
Stimulation On/Off Button
Down/Save
Program Button
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 P To
Unlock
15
Using the Medical Equipment
16
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.
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.
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.
Patient Trial Handbook
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
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.
17
Using the Medical Equipment
18
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.
Low
OK
Full
than one area). To learn about adjusting the stimulation of individual areas, please see
“Selecting Areas for Level Control” on page 21.
Patient Trial Handbook
• Multiple area control is available only if your
system has been programmed to deliver stimulation to separate areas. If you do not have separate 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.
19
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.
Using the Medical Equipment
20
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.
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:
Patient Trial Handbook
When you’ve finished making your change, the Remote Control will return to the Level
screen.
21
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.
Note: Button presses will move from one area to the next and will eventually return you to the Level
screen.
1. From the main Level screen, press the Cbutton
as many times as necessary to cycle through your
programmed area Level screens.
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:
Using the Medical Equipment
22
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.
Patient Trial Handbook
2. Press Duntil the program you want is
highlighted, then press S to activate the program.
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.
23
Using the Medical Equipment
24
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:
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.
• An underline beneath a program number means
that program was the most recently activated or
saved (see below) program.
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.
Patient Trial Handbook
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.
The Remote Control will first ask you to .confirm
that you want to “overwrite” the program; press the
appropriate button.
3. With the active program selected, press T to save
the change in the remote’s memory.
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.
1. After making a change to a program, press D
from any screen to return to the Program screen.
25
Using the Medical Equipment
26
•
If the Trial Stimulator’s battery is full/OK, the Remote Control will return to the
Level screen without displaying a message.
When you press Dfrom the Remote Battery Low
screen, the Remote Control will make a check of the
Trial Stimulator’s battery status also.
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!
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.
Patient Trial Handbook
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.
If the stimulator’s battery is low, this
message will be displayed.
•
27
Using the Medical Equipment
28
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.
The Remote Control will connect to your Trial Stimulator in approximately 30 seconds.
4. Align the cover on the case and slide the cover
into position until it snaps closed.
3. Place the three new AAA batteries in the slots,
matching the positive (+) and negative (-)
markings.
2. Remove the old batteries.
Remote Control Battery Replacement
1. On the rear of the remote, push in slightly and
slide down the battery compartment cover.
Patient Trial Handbook
3. Close the compartment by sliding the
cover on the stimulator case in the
opposite direction.
2. Remove the old battery and place the
new battery in the compartment
matching the positive (+) and negative
(-) markings.
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.
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.
29
Using the Medical Equipment
30
•
•
0000008000
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.
When D is pressed, the Remote Control will go into
idle mode (the display will be blank):
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.
Patient Trial Handbook
Safety Information
31
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
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.
32
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
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 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.
Patient Trial Handbook
33
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
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.
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.
Safety Information
34
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
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.
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.
Patient Trial Handbook
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.
35
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.
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.
Safety Information
36
# Patients
With
Adverse
Event
175
39
Risks
Lead Migration
Infection
Epidural Hemorrhage
Seroma
Hematoma
Paralysis
0%
0.1%
0%
0%
3.7%
16.6%
Intent-toTreat Basis
N = 1056
0%
0.1%
0%
0%
4.4%
19.9%
Implanted
Patient
Basis
N = 880
Table 1: Summary of Risks Identified in the Retrospective Clinical Studies
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.
Patient Trial Handbook
4.4%
46
16
35
22
45
Over/Under Stimulation, Ineffective Pain
Control
Intermittent Stimulation
Pain Over Implant
Allergic Reaction
Skin Erosion
Lead Breakage
Hardware Malfunction
Loose Connection
Battery Failure
Other
5.1%
0.2%
0%
2.5%
4.0%
0%
0.7%
1.8%
0%
5.2%
0.6%
37
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
4.3%
0.2%
0%
2.1%
3.3%
0%
0.6%
1.5%
0%
0.5%
CSF Leak
Safety Information
1
Lead Migration
Output malfunction
Infection
Pain
Lead explanted
Infection treated
Device replaced
Lead repositioning
and subsequent
replacement
Resolution
38
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.
Number of Patients
Type
Table 2: Clinical Experience Safety
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.
Patient Trial Handbook
Ohnmeiss, D., R. Rashbaum, M. Bogdanffy. Prospective Outcome Evaluation of Spinal Cord Stimulation in
Patients With Intractable Leg Pain. Spine, 21:1344-1351, 1996.
39
Lang, P. “The Treatment of Chronic Pain by Epidural Spinal Cord Stimulation.” AXON, 18(4): 71-73, 1997.
Kumar, K., C. Toth, R. Nath, and P. Lang. “Epidural Spinal Cord Stimulation for Treatment of Chronic PainSome Predictors of Success. A 15 year experience.” Surg Neurol, 50: 110-120, 1998.
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.
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.
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.
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.
References
Safety Information
40
•
•
•
•
are unable to operate the SCS system
have failed trial stimulation by failing to receive effective pain relief
are poor surgical risks
are pregnant
Contraindications
Patients contraindicated for permanent SCS therapy are those who:
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.
Spieglemann, R. and W.A. Friedman. “Spinal Cord Stimulation: A Contemporary Series.” Neurosurg 28:6571, 1991.
Segal, R., B. Stacey, T. Rudy, S. Basser, J. Markham. “Spinal Cord Stimulation Revisited.” Neurological
Research, 20:391-396, 1998.
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.
Patient Trial Handbook
Cardiac Pacemakers.
41
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.
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.
Pediatric Use.
The safety and effectiveness of spinal cord stimulation has not been
established for pediatric use.
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.
Warnings
Safety Information
42
• 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
Electromagnetic Interference.
Strong electromagnetic fields can potentially turn the
stimulator off, or cause uncomfortable or jolting stimulation. Avoid or exercise care around:
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.
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.
Patient Trial Handbook
•
lithotripsy — high-output sound or shock waves often used to treat gall stones
and kidney stones
Medical Devices/Therapies.
43
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:
Physician training is required.
Precautions
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.
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.
Safety Information
44
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.
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.
•
Patient Trial Handbook
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
In some cases, the skin over your implant may become very thin over time. If this occurs,
contact your physician.
Implant Location.
45
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.
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.
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.
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:
Safety Information
46
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.
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).
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.
may be able to restore stimulation by reprogramming the implant in the clinic or
repositioning the lead during another operation.
Patient Trial Handbook
•
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.
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:
Cell Phones.
47
While we don’t anticipate any interference with cell phones, the full effects of
interaction with cell phones are unknown at this time.
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.
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.
Component Disposal. Do not dispose of the Remote Control or Charger in fire. The battery
Safety Information
48
•
•
•
•
•
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.
Patient Trial Handbook
•
•
•
•
•
•
49
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.
Safety Information
50
Patient Trial Handbook
Help
2. When the indicator light is blinking and you still
do not feel 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.”
No Stimulation
Stimulation
51
52
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.
Stimulation Coverage is in a Different Area Than at the Doctor’s Office
2. Always keep the Remote Control with you, so that you can adjust your stimulation
levels as needed.
1. Stimulation can change depending on body position (lying down, standing or bending).
Stimulation Increases or Decreases on Its Own
4. Call your physician’s office if the above steps do not solve the problem.
3. When the indicator light is not blinking and you do not feel stimulation, replace the Trial
Stimulator battery.
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.
Patient Trial Handbook
The batteries in your Remote Control need to be
replaced with three fresh AAA batteries (refer to
“Remote Control Battery Replacement” on page 28).
“Remote Battery Low” on the Display
Remote Control Display
53
Help
54
Call our Customer Service Department at (866) 360-4747 if the problem continues.
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.
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.
“No Response” on the Display
Patient Trial Handbook
1. Wash the belt with mild soap and warm water.
Washing the Velcro® Belt
Accessories
55
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.
Note: The remote will go to idle mode when D is pressed,
or within fifteen seconds if D is not pressed.
Please call our Customer Service Department at your
earliest convenience to report the error code.
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.
“Action Failed” on the Display
Help
56
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
•
•
•
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:
Patient Trial Handbook
implantable device used to control the
rhythm of the heart.
CARDIAC PACEMAKER. A small
connecting the exposed portion of
temporary lead(s) to the Trial Stimulator.
CABLE. Thin plastic coated wire(s)
C Area Button icon.
leg or left leg where stimulation will
occur.
AREA. A location on the body such as right
delivered stimulation. (See Level.).
AMPLITUDE. The measure-of-strength of
ADVERSE EFFECT. Undesirable result.
Glossary
57
An electrical pulse generator used during
the Trial Phase of SCS therapy evaluation.
EXTERNAL TRIAL STIMULATOR (ETS).
interfere with a variety of electrical
signals including spinal cord stimulation.
ELECTROMAGNETIC INTERFERENCE
(EMI). Electromagnetic signals that
created by a pulse generator.
ELECTRICAL STIMULATION.The energy
called an implantable pulse generator
(IPG); used to send electrical pulses to the
spinal cord or other parts of the body.
ELECTRICAL PULSE GENERATOR. Also
DISPLAY. The Remote Control screen.
to heat body tissue by high-frequency
electromagnetic currents.
DIATHERMY. A therapeutic procedure used
Glossary
58
lead away from the spinal cord.
LEAD MIGRATION. The movement of a
on the trial lead cables to show where to
attach the cables to the Trial Stimulator .
LABELS. Adhesive tags (2-R) (1-L) placed
Stimulator and the IPG Charger.
INDICATOR. A signal light used on the Trial
the skin.
INCISION. Small surgical cut or opening in
used to control stimulation.
electrical stimulation.
PARESTHESIA. Sensation produced by
of pain locations, occurrences, and
intensity. A pain "chart" for determining
therapy.
PAIN PROFILE. A record or documentation
of a nuclear magnetic resonance
spectrometer to produce electronic images
of tissues and organs.
MRI. Magnetic Resonance Imaging; the use
screen to identify the amplitude or
strength of stimulation pulses.
LEVEL. Term used on the Remote Control
stimulation pulses from a pulse generator
to the spinal cord.
Remote Control is not being used. See
also Sleep Mode.
IMPLANT. Small electrical pulse generator
LEAD. A surgical wire that sends electrical
IDLE MODE. A time-out period when the
Patient System Handbook
should be aware of in order to avoid
potentially uncomfortable stimulation
sensations and/or damage to your
stimulation system.
PRECAUTION. Generally, situations that you
system, pulse generator and leads,
implanted in the body and maintained by a
pulse generator battery Charging System.
PERMANENT IMPLANT. A stimulator
wallet size card that lists the patient and
physician names, and IPG model and
serial number.
PATIENT IDENTIFICATION CARD. A
placed on the skin and attached to the Trial
Stimulator only when trial leads are not
used.
PATCH ELECTRODE. An adhesive patch
59
method of applying electrical pulses to the
spinal cord to block/mask pain signals to
the brain.
SPINAL CORD STIMULATION (SCS). A
Remote Control is not being used. See
also Idle Mode.
SLEEP MODE. A time-out period when the
used to store a newly created or modified
stimulation program.
SAVE. The Remote Control button command
hand-held computer used to adjust
stimulation.
REMOTE CONTROL. A battery powered
D Program Button icon.
stimulation areas.
PROGRAM. Combination of one or more
Glossary
60
activity log used to record information
during the Trial Phase.
TRIAL JOURNAL. Questionnaire, chart and
of electrical stimulation of the spinal cord.
TRIAL SCREENING. Temporary evaluation
system to deliver stimulation therapy.
SYSTEM FAILURE. Inability of stimulator
E Stimulation On/Off Button icon.
body where stimulation occurs. (See
Area.)
be aware of to avoid serious situations that
may cause injury or death.
WARNING. Potential hazards that you must
graph used to chart before-and-after pain
levels included in the Pain Profile.
VAS. Visual Analog Scale. Numerical scale/
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.
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
TRIAL STIMULATOR SYSTEM. Precision
STIMULATION. When used as a therapy for
Patient System Handbook
MRI .................................................... 49
level .................................................... 20
label .................................................... 13
indicator ............................................. 12
diathermy ..................................... 41, 57
cable ............................................. 10, 52
Index
VAS ..................................................7, 8
Trial Journal .........................................7
Patient Identification card ..................12
paresthesia ............................................2
61
Index
62
Patient Trial Handbook
63
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.
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.
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 operation.
The following is federal government communications regulation information about the Precision™ System.
64
Patient Trial Handbook

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