50589644-02B, Part Number: 92366120-001, Model(s): System integrity could be compromised and harm or injury to the patient could occur if the medical devices are subjected to unauthorized modification. Do not implant the device if the case is damaged. They receive years of advanced training in pain management and focus on treating patients with severe pain. Associated conditions and etiologies may be: radicular pain syndrome, radiculopathies resulting in pain secondary to failed back syndrome or herniated disc, epidural fibrosis, degenerative disc disease (herniated disc pain refractory to conservative and surgical interventions), arachnoiditis, multiple back surgeries. 3501, Part Number: Contraindications, warnings, precautions, side effects. 90981810-01A, Part Number: 90996662-02A, Part Number: Patients using therapy that generates paresthesia should not operate motorized vehicles such as automobiles or potentially dangerous machinery and equipment with the stimulation on. Patients implanted with the Precision Spectra or Spectra WaveWriter Spinal Cord Stimulator Systems with ImageReady MRI Technology are ""MR Conditional"" only when exposed to the MRI environment under the specific conditions defined in the applicable ImageReady MRI Head Only Guidelines for Precision Spectra or Spectra WaveWriter Spinal Cord Stimulator Systems. Boston Scientifics ImageReady MRI Full Body Technology makes safe MRI scans possible. 50816633 -01A, Part Number: Use our finder to explore pain management specialists in your area. 90948431-01B, Multiple Electrode Recording and Pacing Catheter, Part Number: 50444283-02A, Safety Related Revision? These spectra contain long-range intra- and intermolecular correlations, which are not easily accessible in conventional experiments without DNP. Coventor Adult Manual Resuscitator Compressor-IFU. Caution: U.S. Federal law restricts this device to sale by or on the order of a physician. I would like to see proof that your solutions may work. Boston Scientific offers solutions to help manage pain experienced in the back, neck, shoulders, legs, or lower limbs. 357203-006, Model(s): Track your pain, prepare for your discussion, guide the conversation, and become your best advocate. Do not drop them or submerge them in water. The DOI system 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. 72404043, 72404324, 72404325, 72404326, Part Number: This is the web site of the International DOI Foundation (IDF), a not-for-profit membership organization that is the governance and management body for the federation of Registration Agencies providing Digital Object Identifier (DOI) services and registration, and is the registration authority for the ISO standard (ISO 26324) for the DOI system. SIT-361, SIT-470, Part Number: For appropriate guidance, consult the instructions for use for these active devices. Strong electromagnetic fields can potentially turn stimulation off, cause temporary unpredictable changes in stimulation, or interfere with Remote Control communication. 1006-02, Part Number: 92123951-001, Part Number: Use our Doctor Locator to explore pain management specialists in your area. 55-64 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. Boston Scientific offers solutions to help manage pain experienced in the back, neck, shoulders, legs, or lower limbs. Nine out of ten patients in the clinical study were satisfied with their pain relief and increase in physical activity.1,, Learn more about the effectiveness of the Vertiflex Procedure. Your doctor may be able to provide additional information on the Boston Scientific Spinal Cord Stimulator systems. All rights reserved. RFA is a minimally invasive outpatient procedure that uses thermal energy to interrupt pain signals at the source. Possible surgical procedural risks are: temporary pain at the implant site, infection, cerebrospinal fluid (CSF) leakage and, although rare, epidural hemorrhage, seroma, hematoma and paralysis. 2022 Boston Scientific Corporation or its affiliates. 91063583-01 Rev C, Model(s): Non-binary 6215, 6216, Part Number: The Spinal Cord Stimulator systems are not for patients who are unable to operate the system, have failed trial stimulation by failing to receive effective pain relief, are poor surgical candidates, or are pregnant. 92116951-01A, Model(s): For therapy that does not generate paresthesia (i.e., subperception therapy) it is less likely that sudden stimulation changes resulting in distraction could occur while having stimulation on when operating moving vehicles, machinery, and equipment. Refer to the Instructions for Use provided with Boston Scientific generators, electrodes and cannulas for potential adverse effects, additional warnings and precautions prior to using these products. Find useful resources to help you cope with your pain and learn what options there are to help you find relief. 50618233-01A, Model(s): 91078744-04 REV C, Part Number: Key Resources Directions for Use Reimbursement Patient Education Indications, Safety, and Warnings We will guide you on how to place your essay help, proofreading and editing your draft fixing the grammar, spelling, or formatting of your paper easily and cheaply. Explore the different kinds of pain so that you can most effectively communicate with your doctors. Available 5 am to 5 pm PT, Monday through Friday, Deliver effective, personalized relief solutions for your patients with back, neck, shoulder, Contraindications. Warnings. If using therapy that does not produce a sensation (subperception), postural changes are less likely to affect the patient. The Boston Scientific RF Injection Electrodes are used for percutaneous nerve blocks with local anesthetic solution for radiofrequency lesioning of peripheral nerve tissue only. While charging, the Charger may become warm. Boston Scientifics ImageReady MRI Technology makes safe MRI head scans possible. Which of the following treatments are you currently using or have used in the past? Here you will find important information about our latest ImageReady MRI technology, supported devices and conditions for use. For a patient with a cardiac pacemaker, contact the pacemaker company to determine whether the pacemaker needs to be converted to fixed rate pacing during the radiofrequency procedure. AdVance XP Male Sling System. 359160-004, Model(s): 6293, Part Number: Indications for Use: The Boston Scientific Spinal Cord Stimulator Systems are 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, Complex Regional Pain Syndrome (CRPS) Types I and II, intractable low back pain and leg pain. Indications, Safety, and Warnings. You should speak to a pain management specialist before making a determination about any therapies or procedures. 91057051-01 REV A, Part Number: 65 and over Leg and back pain may be the result of a condition called lumbar spinal stenosis. The system should not be charged while sleeping. Four ports and an unrivaled percutaneous lead portfolio for unmatched flexibility, now and DB-1140-S, Part Number: M365DB7105N310, Part Number: Treatment and pain relief for Lumbar Spinal Stenosis (LSS). You should speak to a pain management specialist before making a determination about any therapies or procedures. Patients implanted with the Precision Spectra or Spectra WaveWriter Spinal Cord Stimulator Systems with ImageReady MRI Technology are "MR Conditional" only when exposed to the MRI environment under the specific conditions defined in the applicable ImageReady MRI Head SC-9310, Part Number: Patients should be advised to avoid or exercise care around the following: Note: When in close proximity, equipment that generate strong electromagnetic fields might cause unintended stimulation or interfere with wireless communication even if they comply with CISPR requirements. Watch how the Vertiflex Procedure can relieve leg and back pain associated with LSS. 350007-003, Part Number: Warnings. As an operator of the external devices, perform only the following service and maintenance tasks on the external devices: Ensure that the devices are not in use while performing service and maintenance tasks. 359450-007, Model(s): Discover more about the different kinds of treatment and the doctors who will try to help you manage your pain. 92161116-03, Vercise PC and Vercise Gevia DBS Systems, Model(s): 359494-003, Transcatheter Aortic Valve Prosthesis Premounted on Delivery System, Model(s): The spacer preserves the space in the spine, which keeps pressure off the nerves that cause leg and back pain. Caution: U.S. Federal law restricts this device to sale by or on the order of a physician. Designed for more coverage, more flexibility, and advanced control, the Precision Spectra SCS System is engineered to provide more pain relief to a broader spectrum of patients. S201, S203, S204, S205, S208 S401, S402, S403, S404 S601, S602, S603, S604, S605, S606 1195, 1198, 1294, 1295, 1296 1194, 1297, 1298 1190, 1290, 1291, Part Number: 7740, 7741, 7742, Part Number: The underbanked represented 14% of U.S. households, or 18. leg, or lower limb pain. 50654567-01A, Model(s): Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the 358080-001, Part Number: The Boston Scientific RF Injection Electrodes are used for percutaneous nerve blocks with local anesthetic solution for radiofrequency lesioning of peripheral nerve tissue only. Contact Customer Support. Download your Doctor Discussion Guide. 90961048-02B, Part Number: Refer to the Instructions for Use provided on www.vertiflex.com for additional Indications for Use, contraindications information and potential adverse effects, warnings, and precautions prior to using this product. 800-CARDIAC (227-3422) If the device stops working even after complete charging (up to four hours), Patients should turn off the Stimulator and contact their healthcare provider so that the system can be evaluated. Cleaning wipes for the External Trial Stimulator can also be ordered through Boston Scientific customer service. This drug-free therapy can be personalized to deliver lasting relief. 55-64 This drug-free therapy can provide months of safe, effective pain relief. subperception therapy) it is less likely that sudden stimulation changes resulting in distraction could occur while having stimulation on when operating moving vehicles, machinery, and equipment. MRI examinations performed on patients with the WaveWriter Alpha or WaveWriter Alpha Prime SCS System using opensided MRI systems, or other types of MRI systems operating at other static magnetic field strengths (higher or lower), have not been assessed and, as such, should not be performed. Patients implanted with the Precision Spectra or Spectra WaveWriter Spinal Cord Stimulator Systems with ImageReady MRI Technology are "MR Conditional" only when exposed to the MRI environment under the specific conditions defined in the applicable ImageReady MRI Head Only Guidelines for Precision Spectra or Spectra WaveWriter Spinal Cord Stimulator Systems. Have you been suffering from pain for more than 6 months? When the IPG is in storage mode, it will not connect to a Remote Control or Clinician Programmer. 91005737-02A, Part Number: Based on your pain score, you may not be qualified for one of our pain management solutions at this time. Available 5 am to 5 pm PT, Monday through Friday, Deliver effective, personalized relief solutions for your patients with back, neck, shoulder, . Use our finder to explore pain management specialists in your area. Our Pain Education Specialists can discuss treatment options and help you find a physician near you. SLT-394, SLT-395, Part Number: Do not clean any of the accessories while they are directly or indirectly connected to a power outlet. Password requirements: 6 to 30 characters long; ASCII characters only (characters found on a standard US keyboard); must contain at least 4 different symbols; Those who have a checking or savings account, but also use financial alternatives like check cashing services are considered underbanked. 90511593-01B, Part Number: The next-generation solution for male stress urinary incontinence, the AdVance XP Male Sling System is the worldwide male sling market leader. Stimulators may interfere with the operation of implanted sensing stimulators such as pacemakers or cardioverter defibrillators. Safety Related Revision? Have you been suffering from pain for more than 6 months? 3889, Part Number: SC-9305, Part Number: 1 You have been suffering from pain for . The Boston Scientific Radiofrequency Generators, associated Radiofrequency Lesion Probes and RF Cannula are indicated for use in procedures to create radiofrequency lesions for the treatment of pain or for lesioning nerve tissue for functional neurosurgical procedures. 5 You have tried the following treatments: 6 You are by a pain management specialist. 90741285-01A, Part Number: 91035972-02 Rev A, Part Number: Non-binary EL2045594, Model(s): If patients experience pain or discomfort, they should cease charging and contact Boston Scientific. 359474-002, Model(s): Provide additional information on the boston Scientific offers solutions to help manage pain experienced in the,... 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