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42 Executive Briefing Powered by Illumina 3D ™ FULL-BODY MRI ACCESS * Precision Montage MRI powered by Illumina 3D offers proven pain relief by delivering multiple waveforms to a precise neural target — together with safe access to full-body MRI scans. * Indications for Use. Boston Scientific's Precision Montage MRI Spinal Cord Stimulator 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. Contraindications. The Precision Montage MRI Spinal Cord Stimulator System is not for patients who are unable to operate the system, have failed trial stimulation by failing to receive effective pain relief, are poor surgical risks, or are pregnant. Patients implanted with the Precision Montage MRI Spinal Cord Stimulator System with ImageReady MRI Technology are "MR Conditional" only when exposed to the MRI environment under the specific conditions defined in the ImageReady MRI Guidelines for Precision Montage MRI Spinal Cord Stimulator System manual. Warnings. Patients implanted with the Precision Montage MRI Spinal Cord Stimulator System without ImageReady MRI Technology should not be exposed to Magnetic Resonance Imaging (MRI). Exposure to MRI may result in dislodgement of the stimulator or leads, heating of the stimulator, severe damage to the stimulator electronics and an uncomfortable or jolting sensation. As a Spinal Cord Stimulation patient, you should not have diathermy as either a treatment for a medical condition or as part of a surgical procedure. Strong electromagnetic fields, such as power generators or theft detection systems, can potentially turn the stimulator off, or cause uncomfortable jolting stimulation. The system should not be charged while sleeping. The Precision Montage MRI Spinal Cord Stimulator System may interfere with the operation of implanted sensing stimulators such as pacemakers or implanted cardiac defibrillators. Advise your physician that you have a Spinal Cord Stimulator before going through with other implantable device therapies so that medical decisions can be made and appropriate safety measures taken. Patients should not operate motorized vehicles or potentially dangerous machinery with therapeutic stimulation switched "on." Your doctor may be able to provide additional information on the Precision Montage MRI Spinal Cord Stimulator System. For a copy of the Precision Spinal Cord Stimulator System Patient Handbook, including the indications for use, contraindications, warnings, precautions, and side effects, call 866.360.4747. Caution: Federal (U.S.) law restricts this device to sale by or on the order of a physician. Outside of US Indications for Use: CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labelling supplied with each device. Information for use only in countries with applicable health authority registrations. Material not intended for use in France. All trademarks are the property of their respective owners. NM-279017-AB DEC2016 ©2016 Boston Scientific Corporation or its affiliates. All rights reserved. Printed in the U.S.A. Illumina 3D Programming Introducing Precision Montage ™ MRI *The Precision Montage ™ MRI SCS System provides safe access to full-body MRI scans only when used with the Avista MRI Leads and exposed to the MRI environment under the specific conditions defined in the ImageReady MRI Full Body Guidelines for Precision Montage ™ MRI Spinal Cord Stimulator System. For more information, go to HCP.ControlYourPain.com