MP9055185 Rev A Federal law restricts this device to sale, distribution and use by or on the order of a physician.
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.
2 1 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 ........................................................
iv 5 4 Selecting and Activating Programs ........................................ 23 Saving Program Changes ..................................................... 24 Battery Information ............................................................... 26 Index..................................................................................61 Glossary ...........................................................................57 Stimulation .................................................................
Introduction 1 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.
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.
CAUTION: If your doctor approves of you driving during the trial, always turn off the Trial Stimulator before getting behind the wheel.
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.
• 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. 5 The position and stability of your leads is a vitally important part of the trial experience.
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.
Overview: The Trial Journal 7 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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.
• 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.
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.
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.
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.
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.
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.
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.
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 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.
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.
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.
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.
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.
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).
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.
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.
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.
36 # Patients With Adverse Event 175 39 0 0 1 0 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.
4.4% 46 0 16 6 0 35 22 0 2 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.
1 1 1 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.
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.
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.
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.
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.
• 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.
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.
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.
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.
• 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.
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.
• • • • • • 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.
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.
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.
The batteries in your Remote Control need to be replaced with three fresh AAA batteries (refer to “Remote Control Battery Replacement” on page 28).
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.
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.
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.
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.
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.
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.
MRI .................................................... 49 M level .................................................... 20 label .................................................... 13 L indicator ............................................. 12 I diathermy ..................................... 41, 57 D cable ............................................. 10, 52 C Index VAS ..................................................7, 8 V Trial Journal .........................................
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.
64 Patient Trial Handbook
