We offer products that are MR Conditional for spinal cord stimulation (SCS) and dorsal root ganglion (DRG) therapy. Remove leads slowly (at a suggested rate of 1 cm/s while holding the lead between the thumb and forefinger) to avoid breaking the lead and leaving fragments in the patient. If the operating field is bloody, wipe gloves, lead, stylet, and sheath before handling the lead. 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. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. 71376 MAT-2006974 v2.0 | Item approved for U.S. use only. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. ); complications from unusual physiological variations in patients, including foreign body rejection phenomena; paralysis (loss of motor function, inability to move); Possible deep brain stimulation complications. System testing. The force of the instruments may damage the lead or stylet. For complete MRI guidance, parameters and cautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. For more information about MR Conditional neurostimulation components and systems, including equipment settings, scanning procedures, and a complete listing of conditionally approved components, refer to the MRI procedures clinician's manual for neurostimulation systems(available online atmedical.abbott/manuals). 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. Patient's age, as very young or very old patients may have difficulty performing required monitoring of the device. Schu S, Gulve A, ElDabe S, et al. Confirm that the neurostimulation system is functioning correctly during the implant procedure, before closing the neurostimulator pocket, and after the implant procedure. 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. Detailed information on storage environment is provided in the appendix of this manual. Inaccurate ECG results may lead to inappropriate treatment of the patient. 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). 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 . Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. Patients should cautiously approach such devices and should request help to bypass them. Device components. Stimulation Modes. Wireless use restrictions. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Battery care. Falling and other traumatic accidents can damage shallowly implanted components such as the leads and extensions. This neurostimulation system is contraindicated for patients who are. Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. 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. away from the generator and avoid placing any smart device in a pocket near the generator. Stimulation effectiveness has been established for one year. Conscious sedation during removal. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. If unpleasant sensations occur, turn off stimulation immediately. Proclaim Plus Spinal Column Stimulation (SCS) System PRESCRIPTION AND SAFETY INFORMATION Read this section to gather important prescription and safety information. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. 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. Exposure to body fluids or saline. Do not bend the sheath without the lead inside the sheath, as this will permanently kink it and make it difficult to deploy the lead. This means you can get hassle-free pain relief with a battery that lasts up to 10 years at low-dose settings** without ever needing to charge the system. Component manipulation. Clinician training. Safety Topic / Subject Spinal Cord Stimulation (SCS) Systems, Abbott and St. Jude Medical. If resistance is encountered, pull the needle out of the epidural space and then remove the sheath. Patient selection. Do not crush, puncture, or burn the generator because explosion or fire may result. Expected effect from cessation of therapy, should disease symptoms return unexpectedly. Implantation of two systems. Battery precaution. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. For complete guidance, directions, and cautions on MRI safety with a specific device,please review the MRI procedure clinician's manual. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Keep the device dry. Patients will receive an identification card to carry with them that will inform emergency medical personnel of their implanted system. A summary of the safety and clinical performance (SSCP) for these devices will be published at https://ec.europa.eu/tools/eudamed by the Notified Bodies in accordance with the requirements of EU MDR 2017/745 and associated timelines. If unpleasant sensations occur, the IPG should be turned off immediately. 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,. Computed tomography (CT). Surgical complications include, but are not limited to, the following: intracranial hemorrhage (which can lead to stroke, paralysis, or death); cerebrospinal fluid leakage or cerebrospinal fluid abnormality; persistent pain at surgery site or IPG site; brachial plexus injury (nerves to chest, shoulder and arm); postoperative pain, stress, or discomfort; hemiparesis (muscular weakness or partial paralysis on one side of body); ballism or hemiballism (uncontrollable movements on both or only one side of the body); confusiontransient, nocturnal or ongoing; cognitive impairment, including delirium, dementia, disorientation, psychosis and speech difficulties; pulmonary embolism (sudden blood vessel obstruction); aborted procedures (air embolism, unable to find target, surgical complication, etc. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. Removing a kinked sheath. 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. To correct the effect of interference with other devices, turn off the equipment or increase the distance between the equipment and the device being affected. 74373 MAT-2300644 v2.0 | Item approved for U.S. use only. Higher amplitudes and wider pulse widths may indicate a system problem or a suboptimal lead placement. Operation of machines, equipment, and vehicles. 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.**. High stimulation outputs. Lasting Relief through our smallest system yet. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) (2) The method of its application or use. This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. 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. Implantation of multiple leads. An expiration date (or use-before date) is printed on the packaging. For more information, see the clinician programmer manual. The severity of any surgical complication may be greater in patients with diabetes, particularly those with inadequate pre-operative glycemic control. A risk of brain tissue damage exists with parameter settings using high amplitudes and wide pulse widths. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. communication equipment (such as microwave transmitters and high-power amateur transmitters). Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system. Some models of this system are Magnetic Resonance (MR) Conditional, and patients with these devices may be scanned safely with magnetic resonance imaging (MRI) when the conditions for safe scanning are met. After CT scanning directly over the implanted or externally worn electronic medical device: Have the patient turn the device back on if it had been turned off prior to scanning. 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. Implantation of multiple leads. Advise patients to inform their healthcare professional that they should not be exposed to diathermy treatment. The safety and efficacy of the implantation of greater than four leads have not been evaluated. High-output ultrasonics and lithotripsy. Electromagnetic interference (EMI). Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target. 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. Pediatric use. 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. Exposure to body fluids or saline. Consumer goods and electronic devices. Instruct patients to use their neurostimulation system only after an authorized clinician has programmed the generator and has trained the patient on how to safely control stimulation and to charge the system. A recharge-by date is printed on the packaging. Less serious disadvantages of spinal cord stimulation devices include: Fluctuations in stimulation. Case damage. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. 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. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. Electrosurgery. Use extreme care when using sharp instruments or electrosurgery devices around the lead to avoid damaging the lead. 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. For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual.
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