Do not use excessive pressure when injecting through the sheath. INDICATIONS FOR USE Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals. Use caution when sedating the patient. Ask patients with neurostimulators to shut off the device temporarily while the scan is performed. All components listed must be implanted unless noted as "optional." 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. 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. Surgical advice for removal. Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinsons disease. After defibrillation, confirm the neurostimulation system is still working. Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system. 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. 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. When using a contralateral approach, advance the needle slowly into the epidural space and take caution as it enters. Patients should cautiously approach such devices and should request help to bypass them. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. Nerve damage may result from traumatic or surgical nerve injury. Advise patients who experience these types of stimulation changes to turn down the amplitude or turn off the IPG before making extreme posture changes or abrupt movements such as stretching, lifting their arms over their heads, or exercising. During the implant procedure, if an electrosurgery device must be used, take the following actions:. 71409MAT-2116350 v4.0 | Item approved for U.S. use only. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. Do not use a clinician programmer or patient controller around explosive or flammable gas fumes or vapors. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Stimulation frequencies at less than 30 Hz may cause tremor to be driven (meaning that tremor occurs at the same frequency as the programmed frequency). Preventing infection. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. Deep brain stimulation complications include, but are not limited to, the following: Undesirable changes in stimulation related to cellular changes in tissue around the electrodes, changes in the electrode position, loose electrical connections, or lead fracture, Loss of therapeutic benefit as a result of change in electrode positions, loose electrical connections, or lead or extension fracture, Initial jolt or tingling during stimulation; jolting or shocking sensations, Lead fracture, migration, or dislodgement, Extension malfunction, fracture, or disconnect, Deep brain stimulation system failure or battery failure within the device, Deep brain stimulation system malfunction or dislodgement, Allergic or rejection response to implanted materials, Persistent pain, tightness, or redness at the incision sites or general pain, General erosion or local skin erosion over the IPG, Persistent pain, tightness, or discomfort around the implanted parts (e.g., along the extension path in the neck), Impaired wound healing (e.g., incision site drainage) or abscess formation, Additional neurosurgical procedure to manage one of the above complications or to replace a malfunctioning component, Stimulation-related complications or other complications, Worsening of motor impairment and Parkinsons disease symptoms including dyskinesia, rigidity, akinesia or bradykinesia, myoclonus, motor fluctuations, abnormal gait or incoordination, ataxia, tremor, and dysphasia, Paresis, asthenia, hemiplegia, or hemiparesis, Sensory disturbance or impairment including neuropathy, neuralgia, sensory deficit, headache, and hearing and visual disturbance, Speech or language impairment including, aphasia, dysphagia, dysarthria, and hypophonia, Cognitive impairment including attention deficit, confusion, disorientation, abnormal thinking, hallucinations, amnesia, delusions, dementia, inability to act or make decisions, psychic akinesia, long term memory impairment, psychiatric disturbances, depression, irritability or fatigue, mania or hypomania, psychosis, aggression, emotional lability, sleep disturbance, anxiety, apathy, drowsiness, alteration of mentation, postural instability and disequilibrium, Cardiac dysfunction (e.g., hypotension, heart rate changes, or syncope), Eye disorder including eye apraxia or blepharospasm, (1) The symbol statement Rx only or only or the statement Caution: Federal law restricts this device to sale by or on the order of a ___, the blank to be filled with the word physician, dentist, veterinarian, or with the descriptive designation of any other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device; and. Electromagnetic interference (EMI). Additionally, RFID devices, which are often used to read identification badges, as well as some tag deactivation devices, such as those used at payment counters at stores and loan desks at libraries, may also affect stimulation. Operation of machinery and equipment. Electrical medical treatment. Storage environment. Sources of therapeutic radiation include therapeutic X-rays, cobalt machines, and linear accelerators. radiofrequency identification (RFID) devices. Component fracture or dislodgement may result in loss of stimulation, intermittent stimulation, stimulation at the fracture site, and additional surgery to replace or reposition the component. 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. Nonadjacent leads and extensions have the possibility of creating a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Sheath insertion precaution. Additionally, RFID devices, which are often used to read identification badges, as well as some tag deactivation devices, such as those used at payment counters at stores and loan desks at libraries, may also affect stimulation. To prevent injury or damage to the system, do not modify the equipment. Safety Topic / Subject Spinal Cord Stimulation (SCS) Systems, Abbott and St. Jude Medical. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Component manipulation. The safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established. The Proclaim XR implantable pulse generator (IPG) is a novel device designed to supply low-dose BurstDR stimulation in a primary cell battery guaranteed to last 5-10 years with appropriate programming. Store components and their packaging where they will not come in contact with liquids of any kind. Removing components. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. FDA Expands MRI Compatibility With Spinal Stimulation for Pain Do not bend, kink, or use surgical instruments on the stylet, as this may damage it. If interference occurs, try holding the phone to the other ear or turning off the phone. For more information, see the clinician programmer manual. 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,. Patients who are implanted with nonadjacent multiple leads and patients who are sensitive to low stimulation thresholds may experience a momentary increase in their perceived stimulation, which some patients have described as uncomfortable or jolting. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. Interference with wireless equipment. Keep them dry to avoid damage. Output power below 80 W is recommended for all activations. Confirm that no adverse conditions to MR scanning are present. The patient should be able and willing to use the patient controller and correctly interpret the icons and messages that appear on the screen. Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) for the management of intractable, chronic dystonia, including primary and secondary dystonia, for patients who are at least 7 years old. Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. If the lead extensions are routed in a loop, the loop will increase the potential for electromagnetic interference (EMI). We offer products that are MR Conditional for spinal cord stimulation (SCS) and dorsal root ganglion (DRG) therapy. Advise your patient to avoid manipulating the implanted system components (e.g., the neurostimulator, the burr hole site). Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. This damage could result in loss of therapy, requiring additional surgery for system replacement. The U.S. Food and Drug Administration (FDA) has approved Abbott 's request to expand the magnetic resonance imaging (MRI) compatibility with its Proclaim XR spinal cord stimulation system with . The needle will be inserted at a steeper angle than in an antegrade approach and there is a greater chance of dural puncture that will lead to a cerebrospinal fluid leak. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. Security, antitheft, and radiofrequency identification (RFID) devices. Unlike other SCS systems, the ProclaimXR SCS system is recharge free. This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. Device profile of the Proclaim XR neurostimulation system for the Mobile phones. Abbott (NYSE:ABT) announced today that it received FDA approval for new magnetic resonance imaging (MRI) compatibility for the Proclaim system. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. Store components and their packaging where they will not come in contact with liquids of any kind. Abbott's Proclaim XR Spinal Cord Stimulation System Now - Insider These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. However, some patients may experience a decrease or increase in the perceived level of stimulation. The system is intended to be used with leads and associated extensions that are compatible with the system. Use appropriate sterile technique when implanting leads and the IPG. Diathermy is further prohibited because it may also damage the neurostimulation system components. If patients feel that the TENS device may be interfering with the neurostimulator, patients should discontinue using the TENS device until they talk with their physician. However, advise patients who feel uncomfortable paresthesia during postural changes that they should not operate potentially dangerous equipment such as power tools, automobiles, or other motor vehicles. Ensure the patients neurostimulation system is in MRI mode. Stabilizing the lead during insertion. Safety has not been established for radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system. For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual. Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. The IPG should be placed into the pocket, at a depth not to exceed 4.0 cm (1.57 in), with the logo side facing toward the skin surface. Patients should avoid charging their generator over an incision that has not completely healed. Batteries can explode, leak, or melt if disassembled, shorted (when battery connections contact metal), or exposed to high temperature or fire. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. INTENDED USE This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. If they must go through a gate or doorway containing this type of device, patients should turn off their generator and proceed with caution, being sure to move through the device quickly. Pregnancy and nursing. Explosive or flammable gasses. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions. 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. A recharge-by date is printed on the packaging. Object Info: - MRI Safety Select patients appropriately for deep brain stimulation. Failure to push the short end of the soft tissue anchor into the ligament or fascia may result in lead migration and a procedure to revise the lead location. External defibrillators. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. Patients should not be dependent on drugs and should be able to operate the neurostimulation system. If the sheath needs to be retracted from the epidural space, verify that the steering wing is rotated away from the needle mark no more than 90 degrees. This neurostimulation system is indicated for spinal column stimulation via epidural and intraspinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with complex regional pain syndrome (CRPS) types I and II. This includes oxygen-enriched environments such as hyperbaric chambers. If multiple leads or extensions are implanted, the leads and extensions should be routed in close proximity. Skin erosion. Avoid programming either device in a unipolar mode (using the devices can as an anode) or using neurostimulation system settings that interfere with the function of the implantable cardiac system. Implantation of two systems. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. THE List - MRI Safety Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. 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 use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. Providing strain relief. Reducing the Pains of Chronic Pain Treatment | Abbott Newsroom In addition to those risks commonly associated with surgery, the following risks are associated with using this neurostimulation system: Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your generator immediately.). PATIENTS If this date has been reached or has been exceeded before the date of implantation, the generator should be charged prior to implantation. Careful consideration should be used before using radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system since safety has not been established. If needed, return the equipment to Abbott Medical for service. Stimulation effectiveness. High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. Suicidal ideation, suicide attempts, and suicide are events that have also been reported. In the case that a medical treatment is administered where an electrical current is passed through the body from an external source, first deactivate the IPG by setting all electrodes to off, turning stimulation off, and setting amplitude to zero. Advance the needle and guidewire slowly. Abbott's Proclaim XR Spinal Cord Stimulation System Now Offers Make the Bold Choice Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. 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. Only apply software updates that are published directly by Abbott Medical. The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. Do not bring the suture needle in contact with an IPG, lead, or extension, or the component may be damaged. If radiation therapy is required, the area over the implanted generator should be shielded with lead. separates the implanted generators to minimize unintended interaction with other system components. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. Electromagnetic interference (EMI). Computed tomography (CT). (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Patient's visual ability to read the patient controller screen. Application modification. All components listed must be implanted unless noted as "optional." Household appliances. 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). While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. Infections related to system implantation might require that the device be explanted. Confirm implant locations and scan requirements for the patients system. Device modification. 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. If you are unsure of the policy that applies to the use of this device, please ask for authorization to use it before turning it on.

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