Neurosurgery Pain Management Orthopaedic Surgery Confirm the neurostimulation system is functioning correctly after the procedure. Component manipulation. If the stylet is removed from the lead, it may be difficult to reinsert it. Preventing infection. Place the neurostimulator in Surgery mode before using an electrosurgery device. Implantation of two systems. Proclaim Plus Spinal Column Stimulation (SCS) System PRESCRIPTION AND SAFETY INFORMATION Read this section to gather important prescription and safety information. Component disposal. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. Bending the sheath. 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. Control of the patient controller. To prevent injury or damage to the system, do not modify the equipment. Detailed information on storage environment is provided in the appendix of this manual. Conscious sedation. Loss of coordination is a potential side effect of DBS therapy. Patients should avoid activities that may put undue stress on the implanted components of the neurostimulation system. Bathing. 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. Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target. Advancing components. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. The website that you have requested also may not be optimized for your screen size. This neurostimulation 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. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. To prevent injury or damage to the system, do not modify the equipment. High stimulation outputs and charge density limits. Programmer and controller devices are not waterproof. Unlike other SCS systems, the ProclaimXR SCS system is recharge free. Application modification. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient controller. Household appliances. Object Category Spinal Cord Stimulation Systems: St. Jude Medical. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. The placement of the leads involves some risk, as with any surgical procedure. For more information about MR Conditional deep brain stimulation (DBS) 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 DBS systems(available online atmedical.abbott/manuals). 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. Pediatric use. Explosive and flammable gasses. Charge density can be reduced by lowering the stimulation amplitude or pulse width. Avoid excessive stimulation. Unauthorized changes to stimulation parameters. Implanted systems with non-Abbott leads have not been evaluated for safety while scuba diving or in hyperbaric chambers. 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. All components listed must be implanted unless noted as "optional." Excessive lead migration may require reoperation to replace the leads. For adverse effects observed in SCS clinical studies, refer to the clinical summaries manual for SCS systems. 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. 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. Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the suppression of disabling upper extremity tremor in adult essential tremor patients whose tremor is not adequately controlled by medications and where the tremor constitutes a significant functional disability. Do not bend, kink, or use surgical instruments on the stylet, as this may damage it. Before your patient undergoes an MRI scan: Confirm the MR Conditional components and location of the system. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. Introduction: Spinal cord stimulation is becoming an increasingly used modality for the treatment of chronic pain. Caution patients to not make unauthorized changes to physician-established stimulation parameters. If needed, return the equipment to Abbott Medical for service. The safety and efficacy of the implantation of greater than four leads have not been evaluated. Always perform removal of implanted components with the patient conscious and able to give feedback. The use of high-output devices, such as an electrohydraulic lithotriptor, may damage the electronic circuitry of an implanted generator. Ultrasonic scanning equipment. Implanting physicians should be experienced in stereotactic and functional neurosurgery. Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. Implantation of two systems. 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. Exposure to body fluids or saline. External defibrillation can cause induced currents in the leadextension portion of the neurostimulation system. Learn more about the scan details for our MR Conditional products below. Surgical advice for removal. separates the implanted IPGs to minimize unintended interaction with other system components. This may occur once the lead is in place and is connected to the neurostimulator and activated. While charging the generator, patients may perceive an increase in temperature at the generator site. Before diving or using a hyperbaric chamber, patients should contact their physician to discuss the effects of high pressure on their implanted system. Wireless communications equipment, such as mobile and cordless phones and walkie-talkies, may interfere with the IPG if the equipment gets too close to the IPG. Follow proper infection control procedures. Mobile phones. The following warnings apply to this neurostimulation system. The system is intended to be used with leads and associated extensions that are compatible with the system. Unlike other SCS systems, the Proclaim XR SCS system is recharge free. Electrosurgery. Educate patients and caregivers about these potential risks prior to implantation, and be sure that they know about the importance of ongoing support and follow-up, including when to contact their health care provider. Lead movement. An expiration date (or use-before date) is printed on the packaging. Device components. 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. Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. Diathermy is further prohibited because it may also damage the neurostimulation system components. Placement of lead connection in neck. Damage to the system may not be immediately detectable. Abbott's Prodigy, Proclaim, and Proclaim XR SCS Systems are used to help manage chronic, intractable pain of the trunk and/or limbs, including one-sided or two-sided pain associated with the . Lead movement. Advise patients to use their patient controller to communicate with their IPG only when needed because excessive communication with the IPG can shorten the remaining battery life. When using a contralateral approach, advance the needle slowly into the epidural space and take caution as it enters. 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. High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. Stimulation effectiveness has been established for one year. Security, antitheft, and radiofrequency identification (RFID) devices. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. Operating the device near gas fumes or vapors could cause them to catch fire. The long-term safety and effectiveness of this neurostimulation system has not been established beyond 5 years. The Prodigy MRI SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott's smallest implantable pulse generator (IPG). Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. Sheath insertion precaution. Batteries can explode, leak, or melt if disassembled, shorted (when battery connections contact metal), or exposed to high temperature or fire. Securing the IPG. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. 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. Programmer use. This system is contraindicated for patients who meet the following criteria: The following procedures are contraindicated for patients with a deep brain stimulation system. 71376 MAT-2006974 v2.0 | Item approved for U.S. use only. For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. If a patient experiences new or worsening depression or suicidal ideation, manage these symptoms appropriately. 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. If this date has been reached or has been exceeded before the date of implantation, the generator should be charged prior to implantation. Neurostimulation should not be used on patients who are poor surgical candidates. We offer products that are MR Conditional for spinal cord stimulation (SCS) and dorsal root ganglion (DRG) therapy. Scuba diving or hyperbaric chambers. 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. 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. The force of the instruments may damage the lead or stylet. The clinician programmer and patient controller are not waterproof. Poor surgical risks. 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. Lasting Relief through our smallest system yet. Patients should not be dependent on drugs and should be able to operate the neurostimulation system. Needle positioning. If the implanted system contains components or models not listed in the followingtable, then the system is considered MR Unsafe. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. Return of symptoms and rebound effect. To ensure correct operation, always test the system during the implant procedure, before closing the neurostimulator pocket, and before the patient leaves the surgery suite. 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 . If they must go through or near a gate or doorway containing this type of device, patients should move quickly and then check their IPG to determine if it is turned on or off. Do not resterilize or reimplant an explanted system for any reason. In rare cases, this can create a medical emergency. Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. 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. Pediatric use. Remove the stylet from the lead only when satisfied with lead placement. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). The IPG should be explanted before cremation because the IPG could explode. Physicians should also discuss any risks of MRI with patients. For less than 30 m (100 ft) of water or pressures below 4.0 ATA, durations of less than 60 minutes are recommended. Security, antitheft, and radiofrequency identification (RFID) devices. 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). Nonadjacent leads and extensions have the possibility of creating a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. Electromagnetic interference (EMI). 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. 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). Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) 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,. In addition, a component must be implanted in its approved location as listed in the following table or the entire implanted system is considered MRUnsafe. Keep them dry to avoid damage. 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. 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. Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinsons disease. 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. 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. Advise patients about adverse effects. 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. 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. These patients should not climb ladders or participate in activities where postural changes or abrupt movements could alter the perception of stimulation intensity and cause patients to fall or lose control of equipment or vehicles or injure others. To prevent unintended stimulation, do not modify the operating system in any way. IPGs contain batteries as well as other potentially hazardous materials. Therefore, physicians should consider the following: Preoperatively, assess patients for the risks of depression and suicide. Handle the programmers and controllers with care. Guidance and conditions for MRI safety with neuromodulation systems, neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html, Upper buttock, low back, midline, flank or abdomen, Upper buttock, low back, flank, or abdomen, 6170 directional lead, 30 cm, 0.5-mm spacing, black, Fully implanted in the brain, routed under the scalp, 6010 Guardian cranial burr hole cover system, Fully implanted in the brain, routed under the scalp and connected to an extension, Head and neck, routed to the IPG on the same side of the body as the IPG, Lead-only systems, which consist of at least one implanted lead connected to a lead protection boot, as well as an optional cranial burr hole cover, Full systems, which consist of at least one implantable pulse generator (IPG), lead and extension, as well as an optional cranial burr hole cover. Note: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. The U.S. Food and Drug Administration (FDA) approved Abbott's Eterna spinal cord stimulation (SCS) system for the treatment of chronic pain This neuromodulation device provides an optimized experience with the ability to wirelessly charge as few as five times per year, the lowest recharge burden compared to other rechargeable SCS systems 1,2,3 However, current data shows that most patients using BurstDR Stimulation Therapy do not experience paresthesia. After defibrillation, confirm the neurostimulation system is still working. Electrocardiograms. The system is intended to be used with leads and associated extensions that are compatible with the system. Emergency procedures. (2) The method of its application or use. This neurostimulation 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, intractable low back and leg pain, and diabetic peripheral neuropathy of the lower extremities. 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. Transcutaneous electrical nerve stimulation (TENS). IPG disposal. External defibrillation can cause induced currents in the lead-extension portion of the neurostimulation system. Return any suspect components to Abbott Medical for evaluation. Infections related to system implantation might require that the device be explanted. Implanted cardiac systems. 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. Case damage. Devices with one-hour recharge per day. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Do not use the application if the operating system is compromised (that is, jailbroken). 21 CR 801.109(b) The label of the device, other than surgical instruments, bears: (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. Infection. If any component of the implanted neurostimulation system, such as an IPG, lead, or extension, does not meet the requirements for an MR Conditional system, do not perform an MRI scan. Only apply software updates that are published directly by Abbott Medical. All components listed must be implanted unless noted as "optional." Explosive or flammable gasses. Therapeutic radiation. The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. Do not use the clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Package or component damage. Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. INTENDED USE This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Stylet handling. Sources of therapeutic radiation include therapeutic X-rays, cobalt machines, and linear accelerators. Set the electrosurgery device to the lowest possible energy setting. 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. Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment. Unwanted changes in stimulation may include a jolting or shocking feeling. Patients should exercise reasonable caution when participating in activities that require coordination, including those that they were able to perform prior to receiving DBS therapy (for example, swimming). FDA's expanded . Case damage. Application modification. Lead handling. Less serious disadvantages of spinal cord stimulation devices include: Fluctuations in stimulation.