NM-787914-AA Indications to be used: The Boston Scientific Spinal Twine Stimulator Devices are indicated as an aid within the administration of Long-term intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the subsequent: failed back surgery syndrome, Complicated Regional Pain Syndrome (CRPS) Types I and II, intractable small back pain and leg pain, Diabetic Peripheral Neuropathy of your decrease extremities, radicular pain syndrome, radiculopathies resulting in pain secondary to unsuccessful back syndrome or herniated disc, epidural fibrosis, degenerative disc illness (herniated disc pain refractory to conservative and surgical interventions), arachnoiditis, many back surgeries.
Warnings. Patients implanted with Boston Scientific Spinal Twine Stimulator Units devoid of ImageReady™ MRI Engineering should not be subjected to Magnetic Resonance Imaging (MRI). Exposure to MRI could end in dislodgement from the stimulator or qualified prospects, heating from the stimulator, extreme damage to the stimulator electronics and an awkward or jolting feeling. For a Spinal Wire Stimulation affected person, you should not have diathermy as both a treatment method for your healthcare problem or as Element of a surgical process. Robust electromagnetic fields, including electricity generators or theft detection methods, can perhaps transform the stimulator off, or result in unpleasant jolting stimulation. The program should not be billed when sleeping. The Spinal Wire Stimulator process may possibly interfere Along with the operation of implanted sensing stimulators like pacemakers or implanted cardiac defibrillators.
Keep away from arduous action for 6 months after surgery, contact your medical doctor if there is fluid leaking from a incision, if you have pain, swelling or numbness inside your legs or buttocks or if you tumble. Confer with the Guidance for Use delivered on For extra Indications to be used, contraindications data and possible adverse results, warnings, and precautions before using this product or service.
The Superion Oblique Decompression Program (IDS) is contraindicated for people who: have spinal anatomy that reduce implantation with the device or induce the product to become unstable in situ (i.e., degenerative spondylolisthesis increased than quality 1), Cauda equina syndrome, or prior decompression or fusion for the index degree, scoliosis or spinous method fractures, osteoporosis, infection, allergy or reaction to any metallic or implant or even a substantial Body Mass Index. Stay clear of intense activity for six months after surgery, contact your medical professional if there is fluid leaking from a incision, For those who have pain, swelling or numbness as part of your legs or buttocks or for those who tumble. Check with the Directions for Use presented on for additional Indications to be used, contraindications facts and likely adverse consequences, warnings, and safety measures ahead of working with this item. Caution: U.S. Federal regulation restricts this machine to sale by or around the order of a physician.
Seek advice from the Instructions to be used provided with Boston Scientific generators, electrodes and cannulas for prospective adverse results, further warnings and safeguards previous to working with these merchandise.
The Superion™ Interspinous Spacer is indicated for anyone individuals with impaired physical operate who experience relief in flexion from symptoms of leg/buttock/groin pain, with or without the need of back pain, who have undergone at the very least 6 months of non-operative therapy. The Superion Interspinous Spacer could click here to find out more be implanted at 1 or 2 adjacent lumbar amounts in people in whom treatment method is indicated at not more than two amounts, from L1 to L5.
The try this out Superion™ Interspinous Spacer is indicated for people individuals with impaired physical operate who practical experience aid in flexion from symptoms of leg/buttock/groin pain, with or without back pain, great site that have undergone no less than six months of non-operative therapy. The Superion Interspinous Spacer could be implanted at one or two adjacent lumbar levels in patients in whom therapy is indicated at not more than two concentrations, from L1 to L5.
Advise your medical professional that you do have a Spinal Twine Stimulator before going through with other implantable gadget therapies so that professional medical choices is usually produced and ideal safety actions taken. People employing therapy that generates paresthesia should not work motorized cars for example automobiles or likely hazardous machinery and gear Using the stimulation on. Stimulation must be turned off initially in these kinds of instances. For therapy that would not produce paresthesia (i.e. subperception therapy) it is actually more unlikely that unexpected stimulation changes causing distraction could manifest although having stimulation on when working transferring vehicles, machinery, and machines. Your medical professional could possibly offer more info on the Boston Scientific Spinal Cord Stimulator techniques. For complete indications for use, contraindications, warnings, precautions, and Unintended effects, get in touch with 866.360.4747 or take a look at Pain.com.
Warnings. Clients implanted with Boston Scientific Spinal Twine Stimulator Units without the need of ImageReady™ MRI Technology should not be subjected to Magnetic Resonance Imaging (MRI). Publicity to MRI may well result in dislodgement of your stimulator or leads, heating of your stimulator, significant harm to the stimulator electronics and an unpleasant or jolting feeling. Like a Spinal Wire Stimulation patient, you should not have diathermy as possibly a treatment method for any professional medical situation or as part of a surgical technique. Powerful electromagnetic fields, for instance electrical power turbines or theft detection units, can possibly convert the stimulator off, or induce awkward jolting stimulation. The read here system should not be charged even though sleeping. The Spinal Wire Stimulator system may well interfere Together with the Procedure of implanted sensing stimulators which include pacemakers or implanted cardiac defibrillators.
Warnings: The Boston Scientific RF equipment may possibly trigger interference with Lively equipment for instance neurostimulators, cardiac pacemakers, and defibrillators. Interference might have an affect on the action of such Energetic products or may perhaps injury them.
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Warnings. Individuals implanted with Boston Scientific Spinal Cord Stimulator Techniques devoid of ImageReady™ MRI Technology should not be subjected to Magnetic Resonance Imaging (MRI). Publicity to MRI may perhaps lead to dislodgement in the stimulator or sales opportunities, heating of your stimulator, significant damage to the stimulator electronics and an uncomfortable or jolting go right here feeling. As a Spinal Twine Stimulation affected individual, you should not have diathermy as both a therapy for your professional medical affliction or as part of a surgical process. Solid electromagnetic fields, including electricity turbines or theft detection units, can likely convert the stimulator off, or lead to uncomfortable jolting stimulation. The technique should not be charged whilst sleeping. The Spinal Twine Stimulator method may perhaps interfere Using the Procedure of implanted sensing stimulators for instance pacemakers or implanted cardiac defibrillators.
Indications for Use: The Superion™ Indirect Decompression Process (IDS) is indicated to take care of skeletally mature patients suffering from pain, numbness, and/or cramping in the legs (neurogenic intermittent claudication) secondary to a diagnosis of reasonable degenerative lumbar spinal stenosis, with or without the need of Quality one spondylolisthesis, having radiographic evidence of thickened ligamentum flavum, narrowed lateral recess, and/or central canal or foraminal narrowing. The Superion™ Interspinous Spacer is indicated for all those sufferers with impaired physical purpose who experience aid in flexion from symptoms of leg/buttock/groin pain, with or with no back pain, which have been through at least six months of non-operative therapy. The Superion Interspinous Spacer could be implanted at one or two adjacent lumbar stages in sufferers in whom therapy is indicated at no more than two ranges, from L1 to L5. Contraindications, warnings, precautions, Unwanted side effects.