PRECISION SPECTRA™ SYSTEM INFORMATION FOR PATIENTS Part No.
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Information for Patients CAUTION: Federal law restricts this device to sale, distribution and use by or on the order of a physician. Part No.
Information for Patients Copyright ©2012 Boston Scientific Corporation or its affiliates. All Rights Reserved. These documents are the property of Boston Scientific Corporation and shall not be reproduced, distributed, disclosed, or used for manufacture or sale of device without the express written consent of Boston Scientific Corporation.
Table of Contents Safety Information .................................................................................................2 Indications for Use ........................................................................................................................2 Precision Spectra System Clinical Summary ................................................................................2 Table 1: Summary of Risks Identified in the Retrospective Clinical Studies..............................
1 Safety Information Indications for Use The Boston Scientific Precision Spectra™ 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.
Safety Information trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg pain. Efficacy Evaluation Three (3) clinical literature studies were used to support the effectiveness of the Precision Spectra™ 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.
Information for Patients leg pain, pain when walking, standing pain, pain’s effect on overall lifestyle, and the total analog scale scores were significantly improved from baseline. In this study, 25% of the implanted patients had greater than 50% improvement in pain rating. In addition, 3 patients from this study had their stimulators repositioned due to pain at the original location.
Safety Information Since the majority of the patients were treated for FBSS, this article supports the use of SCS for the treatment of FBSS. In this study, one patient required a revision because of electrode fracture. One patient required removal of the system due to local infection. One patient required replacement of the IPG due to mechanical failure. Overall, 16 of 27 (59%) patients required a total of 36 repositioning procedures. A retrospective analysis performed by Hassenbusch SJ et al.
Information for Patients 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.
Safety Information Table 1: Summary of Risks Identified in the Retrospective Clinical Studies Risks # Patients With Adverse Event Intent-to-Treat Basis N = 1056 Implanted Patient Basis N = 880 Lead Migration Infection 175 39 16.6% 3.7% 19.9% 4.4% Epidural Hemorrhage Seroma 0 0 0% 0% 0% 0% Hematoma Paralysis CSF Leak Over/Under Stimulation, Ineffective Pain Control Intermittent Stimulation Pain Over Implant 1 0 5 46 0.1% 0% 0.5% 4.4% 0.1% 0% 0.6% 5.2% 0 16 0% 1.5% 0% 1.
Information for Patients Clinical Experience-Safety Clinical data has been collected during a clinical study of the Precision System. As of January 15, 2004, 35 subjects were enrolled in the study at multiple sites and 26 subjects had a successful trial stimulation period and were implanted with the Precision System. The follow-up period for the 26 implanted patients ranged from two weeks to six months. The following major adverse events were reported.
Safety Information References Burchiel, K.J., V.C. Anderson, F.D. Brown, R.G. Fessler, W.A. Friedman, S. Pelofsky, R.L. Weiner, J. Oakley,and D. Shatin. “Prospective, Multicenter Study of Spinal Cord Stimulation for Relief of Chronic Back and Extremity Pain.” Spine, 21:2786-2793, 1996. Hassenbusch, S.J., M. Stanton-Hicks, E.C. Covington. “Spinal cord stimulation verses spinal infusion for low back and leg pain”. Acta Neurochirgica, 64:109-115, 1995. Kemler, M.A., G.A.M. Barendse, M. Van Kleef, H.C.W.
Information for Patients Spieglemann, R. and W.A. Friedman. “Spinal Cord Stimulation: A Contemporary Series.” Neurosurg 28:65-71, 1991. Villavicencio, A.T., J.C. Leveque, L. Rubin, K. Bulsara, and J.P. Gorecki. “Laminectomy versus percutaneous electrode placement for spinal cord stimulation.” Neurosurgery, 46:399-406, 2000.
Safety Information 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 Stimulator or leads, heating of the Stimulator, severe damage to the Stimulator electronics and/or increased voltage through the leads or Stimulator which can cause an uncomfortable or “jolting” sensation. Pediatric Use. The safety and effectiveness of spinal cord stimulation has not been established for pediatric use.
Information for Patients Posture. Changes in posture or abrupt movements may cause decreases, or uncomfortable or painful increases in the perceived stimulation level. Keep the Remote Control with you at all times, and turn the stimulation down or off before making posture changes. If unpleasant sensations occur, the stimulation should be turned off immediately. Electromagnetic Interference.
Safety Information Remote Control by pressing the Unlock button and observing the screen. The implant may need to be recharged before stimulation can be restarted. Refer to your Charging Handbook for further information. Always be aware of your surroundings, particularly near theft detectors/security screeners. Ask for assistance to go around these devices if you feel at all uncomfortable. Precautions Physician training is required. Medical Devices/Therapies.
Information for Patients • 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 for proper instructions. Refer to “Contacting Boston Scientific” in this manual for contact information for your locality. Automobiles and Other Equipment.
Safety Information Temporarily, there may be some pain in the area of the implant as the incisions heal. If discomfort continues beyond two weeks, contact your physician. If you notice excessive redness around the wound areas during this time, contact your physician to check for infection and administer proper treatment. In rare cases, adverse tissue reaction to implanted materials can occur during this period. Be sure to consult your physician before making any lifestyle changes due to decreases in pain.
Information for Patients 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 Stimulator and contact your physician so that the system can be evaluated. Operating Temperature. The operating temperature of the Trial Stimulator and Remote Control is 10–40 °C (50–104 °F).
Safety Information The Stimulator should be explanted in the case of cremation, and returned to Boston Scientific. External devices to be disposed of per local regulatory requirements. Please contact your healthcare professional for information. Remote Control, Charging System Cleaning. The charging system components can be cleaned using alcohol or a mild detergent applied with a cloth or tissue. The Remote Control can be cleaned using a mild detergent applied with a lightly dampened cloth or tissue.
Information for Patients • • • • • 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.
Safety Information • 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.
Information for Patients The Precision Spectra™ System components should only be serviced by Boston Scientific. Do not attempt to open or repair any of the components. Unauthorized opening of or attempts to repair the components will void the warranty. Changes of modifications to this product not authorized by Boston Scientific Corporation could void the FCC Certification and negate your authority to operate this product.
Safety Information Approximately one month before the end of the programmed period, the message displays daily. You should contact your health care provider upon receipt of the first message regarding the number of service days remaining. IPG Battery Life The rechargeable battery in the Precision Spectra™ System IPG should provide at least five years of service.1 The IPG recharge interval at typical settings is at least 30 days.2 Over time, the IPG battery will need more frequent recharges.
2 Contacting Boston Scientific There are no user serviceable parts.
3 Glossary ADHESIVE PATCH. Non-reactive skin patch designed to temporarily attach the Charger to the skin over the Stimulator site. ADVERSE EFFECT. Undesirable result, such as side effect. AMPLITUDE. The measure of the strength or level of delivered stimulation. AREA. A location on the body such as right leg or left leg where stimulation will occur. CABLE. Thin plastic coated wire(s) connecting the exposed portion of temporary lead(s) to the Trial Stimulator. CARDIAC PACEMAKER.
Information for Patients CHARGING SYSTEM. The Charging System consists of a Charger Base Station, Charger, Power Supply, Charging Belt and adhesive patches. The system is used for recharging the implanted stimulator. CONTROL BUTTONS. Buttons located on the Remote Control; used for adjusting stimulation settings. DIATHERMY. A therapeutic procedure used to heat body tissue by high-frequency electromagnetic currents. DISPLAY. The Remote Control screen. ELECTRICAL PULSE GENERATOR.
Glossary IPG. Implantable Pulse Generator. LABELS. Adhesive tags placed on the trial lead cables to show where to attach the cables to the Trial Stimulator. LEAD. An insulated surgically implanted wire that sends electrical stimulation pulses from a pulse generator to the spinal cord. LEAD MIGRATION. The movement of a lead away from its original location. LEVEL. Term often used to identify the amplitude or strength of stimulation pulses. MRI.
Information for Patients PARESTHESIA. Tingling sensation produced by electrical stimulation. PATCH ELECTRODE. An adhesive patch placed on the skin and attached to the Trial Stimulator only when trial leads are not used. PATIENT IDENTIFICATION CARD. A wallet size card that lists the patient name, physician name, Stimulator model and serial number. PERMANENT IMPLANT. A stimulator system, pulse generator and leads, implanted in the body and maintained by a pulse generator battery Charging System. PRECAUTION.
Glossary RATE. The number of times–per-second (speed) at which stimulation pulses are delivered to the spinal cord. An option setting available from the Remote Control. REMOTE CONTROL. A battery powered hand-held computer used to adjust stimulation. SAVE. The Remote Control button command used to store a newly created or modified stimulation program. SLEEP MODE. A time-out period when the Remote Control is not being used. Also known as idle mode. SPINAL CORD STIMULATION (SCS).
Information for Patients SYSTEM FAILURE. Inability of spinal cord stimulator system to deliver stimulation. TRIAL JOURNAL. Questionnaire, chart and activity log used to record information during the Trial Phase. TRIAL SCREENING. Temporary evaluation of electrical stimulation of the spinal cord. TRIAL STIMULATOR. An electrical pulse generator used during the Trial Phase of SCS therapy evaluation. TRIAL STIMULATOR SYSTEM.
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