Instruct patients to contact their physician if they experience any adverse effects, such as unusual pain or discomfort during stimulation and swelling, redness, tenderness, or pain around implanted components. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. Explosive and flammable gasses. Infection. The safety and efficacy of the implantation of greater than four leads have not been evaluated. FDA's expanded . Component disposal. The long-term effectiveness of dorsal root ganglion (DRG) stimulation has not been documented, and not all patients realize the long-term benefits from DRG stimulation. Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. Magnetic interference with consumer goods or electronic devices that contain magnets, such as mobile phones and smart watches, may unintentionally cause the neurostimulation system to turn on or turn off or affect communication between the device and generator; however, it will not change the prescribed programmed parameters. Select patients appropriately for deep brain stimulation. Explosive and flammable gasses. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system: Other active implanted devices. If such exposure occurs, clean the affected parts with sterile, deionized water or sterile water for irrigation, and dry them completely prior to lead connection and implantation. Prior to connection, exposure of the metal contacts, such as those on the connection end of a lead or extension, to body fluids or saline can lead to corrosion. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. To prevent unintended stimulation, do not modify the operating system in any way. Security, antitheft, and radiofrequency identification (RFID) devices. Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation. Wireless use restrictions. (2) The method of its application or use. Charge density can be reduced by lowering the stimulation amplitude or pulse width. Programmer use. *Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least two prior pharmacologic treatments from at least two different drug classes and continued their pharmacologic therapy during the clinical study. Proclaim Plus Spinal Column Stimulation (SCS) System PRESCRIPTION AND SAFETY INFORMATION Read this section to gather important prescription and safety information. Do not use the application if the operating system is compromised (that is, jailbroken). Needle positioning. Package or component damage. If such exposure occurs, clean the affected parts with sterile, deionized water or sterile water for irrigation, and dry them completely prior to lead connection and implantation. Nerve damage may result from traumatic or surgical nerve injury. Before your patient undergoes an MRI scan: Confirm the MR Conditional components and location of the system. If the lead extensions are routed in a loop, the loop will increase the potential for electromagnetic interference (EMI). High-output ultrasonics and lithotripsy. Component manipulation by patient. Recharge-by date. Patients without an MR Conditional neurostimulation system should not be subjected to MRI because the electromagnetic field generated by an MRI may damage the device electronics and induce voltage through the lead that could jolt or shock the patient. Abbott (NYSE:ABT) announced today that it received FDA approval for new magnetic resonance imaging (MRI) compatibility for the Proclaim system. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. The use of components not approved for use by Abbott Medical with this system may result in damage to the system and increased risk to the patient. If the patient requires a CT scan, all stimulation should be turned off before the procedure. Infection. Some antitheft devices, such as those used at entrances or exits of department stores, libraries, and other public places, and airport security screening devices may affect stimulation. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. The Eterna SCS 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 and intractable low back and leg pain. Infections may require that the device be explanted. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. NOTE: During intraoperative testing, Surgery mode must be turned off for the neurostimulation system to function correctly. Electromagnetic interference (EMI). For more information about MR Conditional products, visit the Abbott Medical product information page atneuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. The system is intended to be used with leads and associated extensions that are compatible with the system. Do not use short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. Magnetic resonance imaging (MRI). Clinician training. Approved models and implant locations for an MR Conditional lead-only system. Poor surgical risks. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted. While charging the generator, patients may perceive an increase in temperature at the generator site. During implant procedures, if electrosurgery devices must be used, take the following actions: Complete any electrosurgery procedures before connecting the leads or extensions to the neurostimulator. Keep them dry to avoid damage. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems (available online at medical.abbott/manuals). If gas fumes or vapors catch fire, it could cause severe burns, injury, or death. Instruct patients to use their neurostimulation system only after an authorized clinician has programmed the device and has trained the patient how to control stimulation and safely use the system. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. Remove the stylet from the lead only when satisfied with lead placement. Minimize X-ray exposure to the implanted or externally worn electronic medical device by using the lowest possible X-ray tube current consistent with obtaining the required image quality and by making sure that the X-ray beam does not dwell over the device for more than a few seconds. away from the generator and avoid placing any smart device in a pocket near the generator. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. Device modification. Bathing. A multicenter, prospective trial to assess the safety and performance of the spinal modulation dorsal root ganglion neurostimulator system in the treatment of chronic pain. If they must go through a gate or doorway containing this type of device, patients should turn off their IPG and proceed with caution, being sure to move through the device quickly. The effect of other implanted devices, including deep brain stimulators, peripheral nerve stimulators, implanted drug delivery pumps, and cochlear implants on the neurostimulation system are unknown. Do not place the IPG deeper than 4.0 cm (1.57 in) because the clinician programmer or patient controller may not communicate effectively with the IPG. Patients should not be dependent on drugs and should be able to operate the neurostimulation system. Up to two IPGs, leads, extensions, and burr hole covers may be implanted. If the stylet is removed from the lead, it may be difficult to reinsert it. This assessment should consider both the risk of depression and suicide as well as the potential clinical benefits of DBS therapy for the condition being treated. Detailed information on storage environment is provided in the appendix of this manual. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training for dorsal root ganglion (DRG) neurostimulation systems. Always be aware of the needle tip position. The placement of the leads involves some risk, as with any surgical procedure. Abbott's Proclaim XR Spinal Cord Stimulation System Now Offers Expanded MRI Compatibility in U.S. - New U.S. FDA-approved labeling lifts restrictions on 60-centimeter Octrode leads, which are implanted, electrically insulated wires that transmit electrical impulses to the target nerves Conversely, the other active implanted device may interfere with the operation of the neurostimulation system. Patients should cautiously approach such devices and should request help to bypass them. Return them to Abbott Medical for proper disposal. All components listed must be implanted unless noted as "optional." Securing the anchor. WARNING:For a neurostimulation system to be MR Conditional, all implanted components must be approved MR Conditional models and implanted in approved locations according to the following table. Some antitheft devices, such as those used at entrances or exits of department stores, libraries, and other public places, and airport security screening devices may affect stimulation. External defibrillation can cause induced currents in the leadextension portion of the neurostimulation system. Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura. Additional risks to the patients, as a result of the placement and stimulation of the lead in the area of the dorsal root ganglion (DRG), include pain from setting the stimulation parameters too high. Implantation of multiple leads. If lithotripsy must be used, do not focus the energy near the IPG. Safety and effectiveness of neurostimulation for pediatric use have not been established. Care and handling of components. Pregnancy and nursing. Use caution when positioning the needle to avoid unintended injury to surrounding anatomical structures. Confirm the neurostimulation system is functioning.
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