If needed, return the equipment to Abbott Medical for service. In patients who have areas of increased sensitivity to heat, consider placing the implant where the patient has normal sensation. Bending the sheath. Keep programmers and controllers dry. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott. Extension of the upper torso or neck may cause lead movement and alter the stimulation field (especially with leads in the cervical area), resulting in overstimulation or ineffective stimulation. Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for at least six weeks after implantation. Poor surgical risks. If two systems are implanted, ensure that at least 20 cm (8 in.) Patients should avoid activities that may put undue stress on the implanted components of the neurostimulation system. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. 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. 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. Patients should not operate potentially dangerous machinery, power tools, or vehicles or engage in any activity that could be unsafe if their symptoms were to unexpectedly return. Proclaim XR Spinal Cord Stimulation (SCS) System, Model 3660 and Model 3662 . Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. Patients should not dive below 30 m (100 ft.) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Stimulation effectiveness has been established for one year. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Patient activities and environmental precautions. Poor surgical risks. Abbott offers two types of MR Conditional, fully implanted DBS configurations: WARNING: For an MR Conditional system, all implanted components must be approved MR Conditional models. Patient training. Care and handling of components. Do not crush, puncture, or burn the IPG because explosion or fire may result. Clinician training. Patients using therapy that generates paresthesia should turn off stimulation before operating motorized vehicles, such as automobiles, or potentially dangerous machinery and equipment because sudden stimulation changes may distract them from properly operating it. ABBOTT PARK, Ill., Jan. 26, 2023 /PRNewswire/ -- Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has approved its Proclaim XR spinal cord stimulation (SCS) system to treat painful diabetic peripheral neuropathy (DPN), a debilitating complication of diabetes. Some patients may be implanted with the components that make up a Magnetic Resonance (MR) Conditional system, which allows them to receive an MRI scan if all the requirements for the implanted components and for scanning are met. Securing the anchor. Component manipulation by patient. 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. 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). Use caution when positioning the needle to avoid unintended injury to surrounding anatomical structures. Long-term safety and effectiveness. away from the generator and avoid placing any smart device in a pocket near the generator. The following additional considerations should be made for patients with diabetes: A pre-operative risk assessment should be performed for patients with diabetes who are at high risk for ischemic heart disease, those with autonomic neuropathy or renal failure, and patients with a Hemoglobin A1C (HbA1c) 8% (64 mmol/mol). To avoid the risk of skin erosion, implant components at the appropriate depth and inform patients to avoid touching their skin where components are implanted. Detailed information on storage environment is provided in the appendix of this manual. Patients should not be dependent on drugs and should be able to operate the neurostimulation system. Neuromodulation. Case damage. INTENDED USE This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. For specific indications, contraindications, instructions, warnings, precautions, and adverse effects about system components available in your country or region, see the approved clinician's manual for those components. 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. Explosive and flammable gasses. This includes oxygen-enriched environments such as hyperbaric chambers. The system is intended to be used with leads and associated extensions that are compatible with the system. Scuba diving or hyperbaric chambers. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. This equipment is not serviceable by the customer. This neurostimulation system is contraindicated for patients who are. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Application modification. To prevent unintended stimulation, do not modify the operating system in any way. See Full System Components below if the patient has an IPG and extensions implanted. Infections related to system implantation might require that the device be explanted. All components listed must be implanted unless noted as "optional." Handle the device with care. After defibrillation, confirm the neurostimulation system is still working. Instruct patients to designate a representative (family member or close friend) to notify any emergency medical personnel of their implanted neurostimulation system if emergency care is required. Scanning under different conditions may cause device malfunction, severe patient injury, or death. Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control. Store components and their packaging where they will not come in contact with liquids of any kind. Follow proper infection control procedures. Safety Topic / Subject Spinal Cord Stimulation (SCS) Systems, Abbott and St. Jude Medical. 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. 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. If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals. 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. Exposure to body fluids or saline. Surgical complications and adverse events may be more frequent and severe in patients with diabetes. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief. Number of leads implanted. Securing the IPG. For complete and comprehensive MRI support, parameters, and precautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. The IPG should be placed into the pocket, at a depth not to exceed 4 cm (1.57 in), with the logo side facing toward the skin surface. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Neurostimulation should not be used on patients who are poor surgical candidates. Before reinserting the sheath, verify there is no damage to the sheath. New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. Component manipulation. Removing a kinked sheath. Implant heating. 74372 MAT-2215216 v3.0 | Item approved for U.S. use only. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. IPGs contain batteries as well as other potentially hazardous materials. Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinsons disease. To find Shipping Material Packaging Waste information, select Healthcare Professionals. The patient should be able and willing to use the patient controller and correctly interpret the icons and messages that appear on the screen. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. The long-term safety and effectiveness of this neurostimulation system has not been established beyond 5 years. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. The safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established. January 4, 2022 By Sean Whooley. For this reason, programming at frequencies less than 30 Hz is not recommended. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. Loss of coordination is a potential side effect of DBS therapy. External defibrillators. Some equipment in home, work, medical, and public environments can generate EMI that is strong enough to interfere with the operation of a neurostimulation system or damage system components. IPGs contain batteries as well as other potentially hazardous materials. Use extreme care when using sharp instruments or electrosurgery devices around the lead to avoid damaging the lead. Some of this systems electronic equipment, such as the programmer and controller, can radiate radiofrequency (RF) energy that may interfere with other electronic devices, including other active implanted devices. Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket. To prevent unintended stimulation, do not modify the generator software in any way. ), Undesirable changes in stimulation, which may be related to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections, or lead failure or breakage, Stimulation in unwanted places (such as stimulation of the chest wall), Epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement of a lead in the epidural space Cerebrospinal fluid (CSF) leakage, Paralysis, weakness, clumsiness, numbness, sensory loss, or pain below the level of the implant, Pain or bleeding where the needle was inserted, Seroma (mass or swelling) at the implant site, Allergic or rejection response to device or implant materials, Hardware malfunction that requires replacing the neurostimulator, Pain from a noninjurious stimulus to the skin or an exaggerated sense of pain, Formation of reactive tissue in the epidural space around the lead, which can cause delayed spinal cord compression and paralysis and requires surgical intervention (Time to onset can range 23 from weeks to many years after implant.).
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