Out of pain. Into relief.

Transcription

1 Spinal Cord Stimulation for Chronic Pain USING YOUR TRIAL STIMULATION SYSTEM Out of pain. Into relief.

2 SCREENING TRIAL GUIDE AND PATIENT DIARY You are taking an important step in having a trial for spinal cord stimulation (also known as neurostimulation therapy) from Medtronic. With the trial, you have an opportunity to learn how your pain will respond to this device before committing to long-term therapy. This Guide and Patient Diary is organized into four sections: Recording Your Goals for the Trial How to Use Your Trial Neurostimulation System Tracking Your Pain Before the Trial Your Pain Diary make the most of your trial 2 Trial Guide and Diary

3 Record Your Goals It is good to talk with your doctor about the types of activities you would like to participate in if your pain were under control, and setting realistic goals for yourself. Record a few of your goals here, and then see if you re able to achieve them during your trial. My goals for the trial are: Trial Guide and Diary 3

4 You will be sent home with your trial neurostimulation system for 3 to 7 days. Call your doctor if you have any concerns. Your Medtronic representative is available to support you and your doctor with any questions about the neurostimulation system or your settings. Activity Instructions Engage in your normal activities so you and your doctor can evaluate how well the stimulation addresses your pain. Record your pain level on the Pain Diary pages of this brochure. Note if the therapy is: Delivering pain relief Enhancing your ability to perform certain activities Improving your sleep habits Avoid sudden bending or twisting, avoid lifting more than 5 lbs. (e.g., a gallon of milk). Avoid reaching over your head (no reaching up, over, across, down). Do not take a shower or bath and you should not submerge your body in water. You may have a sponge bath but avoid getting the dressing wet. Do not drive while the external neurostimulator is on. Keep dressing dry, clean, and intact. 4 Trial Guide and Diary

5 YOUR TRIAL NEUROSTIMULATION SYSTEM MyStim Programmer In most cases the programmer will be set up very simply. More can be programmed as needed (after you begin receiving long-term therapy). The programmer needs to be over the top of and touching the external neurostimulator to make a change. Do not get the programmer wet. External Neurostimulator (ENS) The red button is a quick stop. For a quick stop you also can unplug the gray screener cable. If the gray screener cable becomes disconnected, reconnect it to the ENS matching the arrow symbols then use your programmer to turn your neurostimulation back on. Do not get the ENS wet. Trial Guide and Diary 5

6 Keep in Mind Your position will affect the intensity of the stimulation. Coughing and sneezing may also affect the stimulation. Keep the gray cable under your clothing. If you are unsure if the neurostimulator is helping, turn your ENS off for a period of time and let the pain return. Then turn the stimulation back on and compare. If you are not receiving adequate relief or if you are having a problem with your neurostimulator, let your doctor know. Either your doctor or your Medtronic representative can adjust your settings so you can get the most out of the trial. If you are uncomfortable during the trial, you can have the system removed. Complications can occur during the trial, including bleeding into the epidural space, infection, and other side effects. You should not undergo a trial if you have an active infection at the time of the test. 6 Trial Guide and Diary

7 HOW TO USE YOUR TRIAL NEUROSTIMULATION SYSTEM If you have questions after working through the instructions, be sure to ask your doctor, or you can also call Medtronic Patient Services toll-free at Visit for more information. Trial Guide and Diary 7

8 Status Row Group Row Parameter Row (Active Row is highlighted with box) MyStim Programmer The programmer needs to be over the top of and touching the external neurostimulator to make a change. 8 Trial Guide and Diary

9 MYSTIM PROGRAMMER OVERVIEW Decrease Button Lowers parameter settings Increase Button Raises parameter settings Therapy Screen Provides system status information, group menu, and parameter settings Power Turns programmer ON and OFF Holding key down turns screen backlight on or off Navigator Keypad Press up and down keys to move the selection box to desired row Press left and right keys to see additional options in a desired row (if your doctor has made them available) On Button Turns neurostimulation ON Off Button Turns neurostimulation OFF Sync Button Communicates with neurostimulator Press at the beginning of each session or to activate a new group Trial Guide and Diary 9

10 STIMULATION SETTINGS Neurostimulation works by delivering mild electrical impulses delivered to an area near your spine. Each pulse can be characterized by its amplitude, pulse width, and these factors combined with the rate of the pulses, determines how the therapy will feel. You will be able to adjust these settings with your MyStim programmer to get the best therapy possible. Your doctor may also create different programming groups to provide customized stimulation for a: Specific activity Pain area Pain type You will then be able to choose a particular group and make adjustments to the settings of that group. This section provides an overview of the adjustments you can make to the stimulation levels. More details will be provided in the following sections. Amplitude is the strength or intensity of stimulation (the tingling sensation). Adjusting the amplitude higher and lower will allow you to select the intensity you prefer. Pulse Width is the duration of the pulse. By adjusting the pulse width, you will be able to change the quality of the tingling sensation. Rate is the frequency or number of pulses delivered each second. A lower rate may be felt as a tapping sensation, or you can increase the rate to make the stimulation feel smoother. 10 Trial Guide and Diary

11 SYNCHRONIZING THE MYSTIM PROGRAMMER AND EXTERNAL NEUROSTIMULATOR Synchronizing establishes communication between the neurostimulator and your MyStim programmer. These two components must be properly communicating or in sync before you can make any stimulation changes. To make this communication possible while adjusting settings, always hold your MyStim programmer directly over the external neurostimulator, with the MyStim programmer screen facing outward. HOW TO: Synchronize the MyStim Programmer and External Neurostimulator a Turn ON the MyStim programmer using the POWER key. Depress and hold the POWER key to turn the backlight ON. b Hold the MyStim programmer over the external neurostimulator. c Press the SYNC key. d One BEEP will sound and the THERAPY screen will appear. Trial Guide and Diary 11

12 1 A HOW TO: Turn the External Neurostimulator ON or OFF Your doctor may suggest you turn the neurostimulator ON or OFF at certain times, such as while you are driving, or if you are changing body positions. a Hold the MyStim programmer over a the external neurostimulator. b Press the neurostimulator ON key. The neurostimulator ON ( ) icon will appear in the top status row. c Press the neurostimulator OFF key. The neurostimulator OFF ( ) icon will appear in the top status row. b 1 mystim A 1.05 Neurostimulator ON mystim 1 A A 1.05 c mystim 1 Neurostimulator OFF mystim A 1.05 mystim Trial Guide and Diary mystim

13 HOW TO: Select and Change a Group Your doctor may have programmed different groups to adjust stimulation for varying activities. You can select the group that best fits your needs. a Hold the MyStim programmer over the external neurostimulator with the screen facing outward. Press the SYNC key to synchronize the MyStim programmer with the external neurostimulator. b The THERAPY screen will appear. Use the up and down NAVIGATOR keys to move the selection box to the middle, group row. c Use the left and right NAVIGATOR keys to select a group. The Group Name may be identified by an icon ( ), letter (A), or text (Legs). Your doctor will determine which group name identifier will be displayed. d Synchronize the MyStim programmer and neurostimulator by pressing the SYNC key. e Verify that the group is active when you see a CHECKED-BOX icon. Trial Guide and Diary 13

14 mystim 1.90 B a b c 1 A A 1.05 mystim mystim mystim d e B 1.90 mystim mystim 14 Trial Guide and Diary

15 ADJUSTING STIMULATION LEVELS DURING THE TRIAL The way you experience neurostimulation therapy may change depending on how you move your body. For example, leaning back may cause the lead to move closer to your spinal cord and increase the sensation of stimulation. Other movements may cause the lead to move further away from your spinal cord and decrease the sensation of stimulation. These changes are normal and not a cause for concern. You can minimize the feeling of these changes by increasing or decreasing the neurostimulation amplitude setting with your MyStim programmer. Note: It is recommended that you turn the amplitude setting down or turn the neurostimulator OFF when changing body positions or making setting adjustments until you become accustomed to the changes that occur. HOW TO: Adjust Parameters (Amplitude, Pulse Width, and Rate) To change the way the neurostimulation feels, your doctor may allow you to select various parameter settings (amplitude, pulse width, rate). If your doctor enabled the Group Adjust feature, you can quickly change all program amplitudes for the active group at the same time. If you want to change the pulse width and/or rate and are unable to, please contact your doctor. a Hold the MyStim programmer over the external neurostimulator with the screen facing outward. Press the SYNC neurostimulator. key to synchronize the MyStim programmer to the external Trial Guide and Diary 15

16 1 A 1 A a The THERAPY screen will appear. Use the up and down NAVIGATOR keys to move the selection box to the parameter row. Use the and right NAVIGATOR keys to select the amplitude, pulse width, rate, or Amplitude Group Adjust. b Hold the MyStim programmer over the neurostimulator and press the INCREASE or DECREASE key to adjust the desired parameter setting. Note: Decrease amplitude before adjusting pulse width or rate or you may feel some discomfort. a b 1 A 1.05 mystim mystim c mystim 1.05 OR mystim 1.05 Pressing Increase Button 16 Trial Guide and Diary Pressing Decrease Button

17 HOW TO: Use the Therapy-Stop Key Typically, you will use the MyStim programmer to turn stimulation OFF. However, if you need to turn stimulation OFF immediately, press the red THERAPY-STOP key. If you turn stimulation OFF using the red THERAPY-STOP key, you must use the MyStim programmer to turn the external neurostimulator ON again. Therapy-Stop button HOW TO: Use the External Neurostimulator Holder A holder is included with your test stimulation system. Use this holder to carry your external neurostimulator on your belt, waistband, or pocket. Place the external neurostimulator into the holder with the red THERAPY-STOP key facing out. HOW TO: Use the Automatic Shut-Off Your screening system is equipped with an automatic shut-off feature in the event of accidental lid opening. To resume neurostimulation if this occurs, snap the lid shut and use your MyStim programmer to turn the neurostimulator back ON. Trial Guide and Diary 17

18 HOW TO: Connect and Disconnect the Cable from the External Neurostimulator To Disconnect the Cable: a Turn the external neurostimulator OFF. b Carefully unplug the cable by pulling on the plug, not the cord. Caution: Do not try to disconnect the leads from the cable, as loss of stimulation will occur when a cable or lead(s) are disconnected. If your lead(s) should disconnect, DO NOT ATTEMPT to reconnect. Contact your doctor to properly reconnect your system. To Reconnect the Cable: a Connect the cable by pointing the arrows on the cable plug and the external neurostimulator toward each other. b Gently insert the plug into the output jack. c Use your MyStim programmer to turn stimulation ON. Caution: Do not pull on the cable. Pulling on the cable may break a wire or dislodge the lead. A broken wire or dislodged lead may result in loss of stimulation and may require surgery to replace the lead. 18 Trial Guide and Diary

19 HOW TO: Check and Replace Batteries in Your MyStim Programmer CHECKING BATTERY LEVELS OF THE PATIENT PROGRAMMER The MyStim programmer is powered by two batteries. These batteries should be checked and changed when they are low to ensure proper performance. a Synchronize the MyStim programmer and external neurostimulator by pressing the SYNC key. b Examine the MyStim programmer battery icon in the top row. c Battery levels are indicated below: MyStim Programmer % Charge 0% 25% 50% 75% 100% REPLACING THE MYSTIM PROGRAMMER BATTERIES: a Open the battery compartment. b Remove old batteries and replace with two new AAA alkaline batteries. a b Trial Guide and Diary 19

20 Note: For more information about using the patient programmer and a complete list of warnings and precautions, refer to the patient user manuals or other literature available from your doctor or you can find the manual on the Tame the Pain website at ELECTROMAGNETIC INTERFERENCE (EMI) Some consumer electronics and power tools generate an electronic field when they are in operation. Neurostimulators include features that protect the device from this interference, and most small household appliances such as microwaves, televisions, computers, and cellular phones should not affect stimulation. If you experience a change in your stimulation level, you may want to try moving your MyStim programmer away from computers, radios, televisions, or other electronic devices. If the stimulation is uncomfortable at any time, use your MyStim programmer to turn the neurostimulator OFF. Or press the THERAPY-STOP key on your external neurostimulator. TROUBLESHOOTING If you experience loss of stimulation during the screening test, make sure the neurostimulator is turned on by looking for the ( ) icon. If it is on, try adjusting your body position or your stimulation amplitude as needed. The MyStim programmer may also display warnings or communication or information screens to alert you to potential problems with your system, or to guide you during programmer use. Talk to your doctor if any warnings are unclear. 20 Trial Guide and Diary

21 TIPS FOR SUCCESS Track your pain relief and activities during the screening test, as well as any changes you make to the stimulation settings. Record the information on the Pain Diary pages within this brochure. Turn your temporary neurostimulation system off approximately every 2 hours when your pain is mild and manageable. Doing this will help your doctor determine how your pain levels change with and without neurostimulation. Disconnect your temporary neurostimulation system at night before you go to sleep. You may continue to experience a sense of stimulation for several hours after turning it off, which is known as the carryover effect. However, if you continue to experience pain at night, reconnect your temporary neurostimulation system and turn it back on. NO Twisting NO Lifting NO Bending Trial Guide and Diary 21

22 TRACK YOUR PAIN BEFORE THE TRIAL It s important to keep track of your pain. When does it occur? What kind of pain is it? Does it move from one place to another? TYPE OF PAIN Your type of pain can be described with words like: Burning Shooting Sharp Radiating Aching Tingling Dull Throbbing Below are directions for completing the following pages: LOCATION OF PAIN Mark the body diagram to show where your pain is located. LEVEL OF PAIN Describe your level of pain from 1 to 10, from very mild to the most excruciating No pain Moderate Excruciating 22 Trial Guide and Diary

23 LOCATION OF PAIN STANDING Level of Pain Describe your level of pain from 1 to 10, from very mild to the most excruciating No pain Moderate Excruciating UPRIGHT Level of Pain Describe your level of pain from 1 to 10, from very mild to the most excruciating No pain Moderate Excruciating Trial Guide and Diary 23

24 LOCATION OF PAIN LEFT SIDE Level of Pain No pain Moderate Excruciating FRONT Level of Pain No pain Moderate Excruciating 24 Trial Guide and Diary

25 LOCATION OF PAIN RIGHT SIDE Level of Pain No pain Moderate Excruciating BACK Level of Pain No pain Moderate Excruciating Trial Guide and Diary 25

26 YOUR PAIN DIARY Keeping a record of the activities you do during the trial and your pain rating can help you and your doctor assess your response to spinal cord stimulation. The following pages can help you do this. A sample page explaining how to fill it out is shown on page 28. Use the blank pages to track your own experiences with spinal cord stimulation. EVALUATING YOUR EXPERIENCE There is a lot to consider when making a decision to proceed with long-term therapy. One way to think about your experience with spinal cord stimulation is to look back on your Pain Diary pages and compare your ability to do things before and during the trial. If you are not receiving adequate relief, tell your doctor right away. Your doctor and the Medtronic representative can adjust your settings. By simply having your settings changed, you may have better pain relief during your trial. 26 Trial Guide and Diary

27 Use the space below to write down goals you can share with your doctor: Things I couldn t do before spinal cord stimulation: Things I could do more comfortably with spinal cord stimulation: Questions for my doctor: Trial Guide and Diary 27

28 YOUR PERSONAL ACTIVITY LOG DAY: Tuesday Activity STANDING UPRIGHT LEFT SIDE FRONT RIGHT SIDE BACK NOTES FOR THE DAY: 28 Trial Guide and Diary Amplitude Setting 8 V Pain Rating 1=no pain 10=worst pain imaginable Describe difference between stimulation off vs. on 6 Stood at the park taking pictures of my kids and gran randkids with stim on and had to sit on the bench with stim off 5.5 V 8 Walked to the back of the grocery store without resting with stim on and couldn t make it through the grocery store with stim off 7 V 7 Watched a movie with my spouse comfortably on the couch with stim on 3.2 V 6 Was not able to lay down comfortably with stim off 7 V 9 Slept through the night with stim on 5.5 V 6M6 Was not able to lay down comfortably with stim off SAMPLE Had good coverage of pain in my right leg and low back ack. I was able to go grocery shopping.

29 YOUR PERSONAL ACTIVITY LOG DAY: Activity Amplitude Setting Pain Rating 1=no pain 10=worst pain imaginable Describe difference between stimulation off vs. on STANDING UPRIGHT LEFT SIDE FRONT RIGHT SIDE BACK NOTES FOR THE DAY: Trial Guide and Diary 29

30 YOUR PERSONAL ACTIVITY LOG DAY: Activity Amplitude Setting Pain Rating 1=no pain 10=worst pain imaginable Describe difference between stimulation off vs. on STANDING UPRIGHT LEFT SIDE FRONT RIGHT SIDE BACK NOTES FOR THE DAY: 30 Trial Guide and Diary

31 YOUR PERSONAL ACTIVITY LOG DAY: Activity Amplitude Setting Pain Rating 1=no pain 10=worst pain imaginable Describe difference between stimulation off vs. on STANDING UPRIGHT LEFT SIDE FRONT RIGHT SIDE BACK NOTES FOR THE DAY: Trial Guide and Diary 31

32 YOUR PERSONAL ACTIVITY LOG DAY: Activity Amplitude Setting Pain Rating 1=no pain 10=worst pain imaginable Describe difference between stimulation off vs. on STANDING UPRIGHT LEFT SIDE FRONT RIGHT SIDE BACK NOTES FOR THE DAY: 32 Trial Guide and Diary

33 YOUR PERSONAL ACTIVITY LOG DAY: Activity Amplitude Setting Pain Rating 1=no pain 10=worst pain imaginable Describe difference between stimulation off vs. on STANDING UPRIGHT LEFT SIDE FRONT RIGHT SIDE BACK NOTES FOR THE DAY: Trial Guide and Diary 33

34 YOUR PERSONAL ACTIVITY LOG DAY: Activity Amplitude Setting Pain Rating 1=no pain 10=worst pain imaginable Describe difference between stimulation off vs. on STANDING UPRIGHT LEFT SIDE FRONT RIGHT SIDE BACK NOTES FOR THE DAY: 34 Trial Guide and Diary

35 YOUR PERSONAL ACTIVITY LOG DAY: Activity Amplitude Setting Pain Rating 1=no pain 10=worst pain imaginable Describe difference between stimulation off vs. on STANDING UPRIGHT LEFT SIDE FRONT RIGHT SIDE BACK NOTES FOR THE DAY: Trial Guide and Diary 35

36 NEUROSTIMULATION SYSTEMS FOR PAIN THERAPY Brief Summary: Product Technical Manuals and Programming Guides must be reviewed prior to use for detailed disclosure. Indication for Use: Chronic, intractable pain of the trunk and/or limbs including unilateral or bilateral pain. Contraindications: Diathermy. Warnings: Defibrillation, diathermy, electrocautery, MRI, RF ablation, and therapeutic ultrasound can result in unexpected changes in stimulation, serious patient injury or death. Rupture/piercing of neurostimulator can result in severe burns. Electrical pulses from the neurostimulator may result in an inappropriate response of the cardiac device. Precautions: The safety and effectiveness of this therapy has not been established for: pediatric use, pregnancy, unborn fetus, or delivery. Follow programming guidelines and precautions in product manuals. Avoid activities that stress the implanted neurostimulation system. EMI, postural changes, and other activities may cause shocking/jolting. Patients using a rechargeable neurostimulator should check for skin irritation or redness near the neurostimulator during or after recharging. Adverse Events: Undesirable change in stimulation; hematoma, epidural hemorrhage, paralysis, seroma, CSF leakage, infection, erosion, allergic response, hardware malfunction or migration, pain at implant site, loss of pain relief, chest wall stimulation, and surgical risks. For full prescribing information, please call Medtronic at and/or consult Medtronic s website at USA Rx Only Rev 0313 For more information on Medtronic Pain Therapies, visit Medtronic Neuromodulation 710 Medtronic Parkway Minneapolis, MN USA Tel Toll-free UC d EN 2014 Medtronic, Inc. Printed in USA.