CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. A recharge-by date is printed on the packaging. Component handling. Damage to the system may not be immediately detectable. Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system. If the lead is unable to deploy out of the sheath, inject sterile water or saline slowly to release tissue that may have entered between the sheath and the lead. Patients should cautiously approach such devices and should request help to bypass them. Preventing infection. The Proclaim XR SCS System is an implantable spinal cord stimulation device designed to allow patients to attain relief from chronic pain of the trunk and limbs. Do not use excessive pressure when injecting through the sheath. Less serious disadvantages of spinal cord stimulation devices include: Fluctuations in stimulation. For patients who do not feel paresthesia, sudden stimulation changes are less likely to occur and distract them while operating motorized vehicles, machinery, or equipment. Diathermy is further prohibited because it may also damage the neurostimulation system components. Bathing. This damage could result in loss of therapy, requiring additional surgery for system replacement. IPGs contain batteries as well as other potentially hazardous materials. 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. Patient training. 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. 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. Precision Spectra Spinal Cord Stimulator System Innovation Focused on Pain Relief Designed for more coverage, more flexibility, and advanced control, the Precision Spectra SCS System is engineered to provide more pain relief to a broader spectrum of patients. Patients should be advised to not use therapeutic magnets. Ultrasonic scanning equipment. Long-term safety and effectiveness. Electromagnetic interference (EMI). Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. Implantation of two systems. However, some patients may experience a decrease or increase in the perceived level of stimulation. This system is contraindicated for patients who meet the following criteria: The following procedures are contraindicated for patients with a deep brain stimulation system. Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinsons disease. Do not over-manipulate the sheath and lead system as this may result in trauma within the epidural space. Use extreme care when using sharp instruments or electrosurgery devices around the lead to avoid damaging the lead. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Securing the IPG. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) 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. Free from the hassles of recharging. Scuba diving or hyperbaric chambers. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for at least six weeks after implantation. Charge density can be reduced by lowering the stimulation amplitude or pulse width. Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment. IPGs contain batteries as well as other potentially hazardous materials. Do not crush, puncture, or burn the IPG because explosion or fire may result. 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. Before opening any sterile package, verify the kit model number, that the kit is within its expiration (use-before) date, and that the packaging has not been damaged or compromised in any way. Operation of machines, equipment, and vehicles. Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target. Failure to do so may result in difficulty delivering the lead. 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. These activities include but are not limited to climbing ladders and operating potentially dangerous machinery, power tools, and vehicles. Scuba diving or hyperbaric chambers. For CT procedures in which the medical device is in or immediately adjacent to the programmed scan range, the operator should: If practical, try to move external devices out of the scan range. Patients should not use this neurostimulation system if they are pregnant or nursing. Needle positioning. Case damage. If lithotripsy must be used, do not focus the energy near the generator. Remove the stylet from the lead only when satisfied with lead placement. Return the explanted IPG to Abbott Medical. Therapeutic radiation may damage the electronic circuitry of an implanted neurostimulation system, although no testing has been done and no definite information on radiation effects is available. For complete and comprehensive MRI support, parameters, and precautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. During the 2000s about a dozen companies sold and manufactured SCS systems worldwide, including the "big three" (Boston Scientific, Abbott/St. If the operating field is bloody, wipe gloves, lead, stylet, and sheath before handling the lead. *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. If a system does not meet the MR Conditional requirements, consider it MR Unsafe. High stimulation outputs and charge density limits. The patient must be instructed to not rub or exert pressure on implanted components through the skin as this may cause lead dislodgement leading to stimulation at the implant site, IPG inversion leading to the inability to communicate with the device, or skin erosion that can lead to another surgical procedure or possible infection. This system is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation. Patients should avoid getting too close to these types of EMI sources, which include the following examples: commercial electrical equipment (such as arc welders and induction furnaces), communication equipment (such as microwave transmitters and high-power amateur transmitters), high voltage power lines, radiofrequency identification (RFID) devices, and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). Sheath insertion warning. Infections related to system implantation might require that the device be explanted. Household appliances that contain magnets (e.g., refrigerators, freezers, inductive cooktops, stereo speakers, mobile telephones, cordless telephones, standard wired telephones, AM/FM radios, and some power tools) may unintentionally cause the neurostimulation system to turn on or turn off. 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. Transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). Failure to provide strain relief may result in lead migration requiring a revision procedure. Lead damage from tools. Patients should cautiously approach such devices and should request help to bypass them. Return all explanted components to Abbott Medical for safe disposal. 72750 MAT-2215018 v2.0 | Item approved for U.S. use only. These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. 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. 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. The implanted components of this neurostimulation system are intended for a single use only. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. 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. Always remove the trial leads before implanting the implant leads to avoid the risk of infection that may cause death if the leads are not removed. radiofrequency identification (RFID) devices. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system. Operation of machines, equipment, and vehicles. 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). Placing the IPG. Needle insertion. Wireless use restrictions. Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the management of disabling tremor. 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. Removing each item in slow movements while holding the remaining components in place will assist this process. **Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia as complex regional pain syndrome (CRPS) types I and II, respectively. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Sheath retraction. 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. The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage.
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