NM-787914-AA Indications for Use: The Boston Scientific Spinal Wire Stimulator Devices are indicated as an support from the administration of Long-term intractable pain on the trunk and/or limbs like unilateral or bilateral pain linked to the following: unsuccessful back surgery syndrome, Elaborate Regional Pain Syndrome (CRPS) Forms I and II, intractable minimal back pain and leg pain, Diabetic Peripheral Neuropathy on the lower extremities, radicular pain syndrome, radiculopathies causing pain secondary to failed back syndrome or herniated disc, epidural fibrosis, degenerative disc disease (herniated disc pain refractory to conservative and surgical interventions), arachnoiditis, various back surgical procedures.
Prevent arduous activity for 6 weeks after surgery, contact your physician if there is fluid leaking from the incision, Should you have pain, swelling or numbness within your legs or buttocks or if you drop. Consult with the Instructions for Use delivered on for additional Indications to be used, contraindications information and facts and potential adverse results, warnings, and safety measures prior to employing this product.
Contraindications. The Spinal Wire Stimulator methods are certainly not for people who are not able to function the system, have failed demo stimulation by failing to acquire effective pain relief, are lousy surgical risks, or are pregnant.
The Superion Indirect Decompression Technique (IDS) is contraindicated for people who: have spinal anatomy that avoid implantation of the system or bring about the system to generally be unstable in situ (i.e., degenerative spondylolisthesis higher than grade 1), Cauda equina syndrome, or prior decompression or fusion on the index degree, scoliosis or spinous system fractures, osteoporosis, an infection, allergy or response to any steel or implant or even a large Human body Mass Index. Steer clear of challenging activity for six months after surgery, contact your medical doctor if there is fluid leaking out of your incision, For those who have pain, swelling or numbness in your legs or buttocks or in the event you fall. Confer with the Guidelines for Use supplied on For extra Indications for Use, contraindications details and prospective adverse effects, warnings, and safeguards before employing this merchandise. Caution: U.S. Federal legislation restricts this gadget to sale by or on the purchase of the physician.
Warnings. Clients implanted with Boston Scientific Spinal Twine Stimulator Programs with no ImageReady™ MRI Technology should not be subjected to Magnetic Resonance Imaging (MRI). Publicity to MRI may possibly result in dislodgement from the stimulator or prospects, heating from the stimulator, severe harm to the stimulator electronics and an awkward or jolting sensation. As a Spinal Cord Stimulation patient, you should not have official source diathermy as both a remedy to get a medical ailment or as Portion of a surgical treatment. Robust electromagnetic fields, such as electric power generators or theft detection programs, can possibly transform the stimulator off, from this source or bring about unpleasant jolting stimulation. The program should not be billed whilst sleeping. The Spinal Twine Stimulator procedure could interfere With all the Procedure of implanted sensing stimulators such as pacemakers or implanted cardiac defibrillators.
The Superion™ Interspinous Spacer is indicated for anyone individuals with impaired physical perform who expertise reduction in flexion from symptoms of leg/buttock/groin pain, with or with out back pain, which have been through a minimum of 6 months of non-operative therapy. The Superion Interspinous Spacer could be implanted at one or two adjacent lumbar concentrations in individuals in whom procedure is indicated at not more than two concentrations, from L1 to L5.
Make reference to the Guidelines to be used furnished with Boston Scientific generators, electrodes and cannulas for likely adverse results, further warnings and precautions before using these goods.
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Seek advice from the Recommendations for Use offered with Boston Scientific turbines, electrodes and cannulas for potential adverse effects, supplemental warnings and safety measures just before making use of these products.
Consult with the Guidance for Use presented with Boston Scientific generators, electrodes and cannulas for likely adverse results, supplemental warnings and precautions find more prior to applying these solutions.
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Indications for Use: The Superion™ Indirect Decompression Program (IDS) is indicated to treat skeletally experienced clients struggling from pain, numbness, and/or cramping during the legs (neurogenic intermittent claudication) secondary to a prognosis of moderate degenerative lumbar spinal stenosis, with or without having Quality one spondylolisthesis, acquiring radiographic proof 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 without back pain, who've undergone a minimum of six months of non-operative procedure. The Superion Interspinous Spacer may very well be implanted at a few adjacent lumbar ranges in sufferers in whom remedy is indicated at not best website more than two degrees, from L1 to L5. Contraindications, warnings, precautions, Unintended effects.