If a system does not meet the MR Conditional requirements, consider it MR Unsafe. Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards. Infections related to system implantation might require that the device be explanted. ), 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.). Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for six to eight weeks after implantation of a neurostimulation system. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Safety has not been established for radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system. Spinal cord stimulation of the dorsal root ganglion for groin pain-a retrospective review. 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 the programming of stimulation parameters exceeds the charge density limit of 30 C/cm2, a screen will appear warning you that the charge density is too high. This may occur once the lead is in place and is connected to the neurostimulator and activated. Remove leads slowly. Do not use surgical instruments to handle the lead. 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 device should be turned off and the doctor contacted if this occurs. To prevent injury or damage to the system, do not modify the equipment. 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. A risk of brain tissue damage exists with parameter settings using high amplitudes and wide pulse widths. (2) The method of its application or use. IPG disposal. The following precautions apply to this neurostimulation system. Mobile phones. Keep them dry to avoid damage. Keep them dry to avoid damage. and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). If radiation therapy is required, the area over the implanted IPG should be shielded with lead. The following warnings apply to this neurostimulation system. Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. Therefore, physicians should consider the following: Preoperatively, assess patients for the risks of depression and suicide. Detailed information on storage environment is provided in the appendix of this manual. Patients should be advised to not use therapeutic magnets. 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. To prevent unintended stimulation, do not modify the operating system in any way. Introduction: Spinal cord stimulation is becoming an increasingly used modality for the treatment of chronic pain. The website that you have requested also may not be optimized for your screen size. For less than 30 m (100 ft) of water or pressures below 4.0 ATA, durations of less than 60 minutes are recommended. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training for dorsal root ganglion (DRG) neurostimulation systems. External defibrillators. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. If multiple leads or extensions are implanted, the leads and extensions should be routed in close proximity. Damage to shallow implants. *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. 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. Surgical advice for removal. Make the Bold Choice The Proclaim XR SCS system can provide relief to . Lead damage from tools. Sheath rotation. Bathing. Conversely, the other active implanted device may interfere with the operation of the neurostimulation system. Additional Disadvantages. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. If lithotripsy must be used, do not focus the energy near the IPG. Always be aware of the needle tip position. Case damage. The system is intended to be used with leads and associated extensions that are compatible with the system. This includes oxygen-enriched environments such as hyperbaric chambers. 74373 MAT-2300644 v2.0 | Item approved for U.S. use only. For adverse effects observed in SCS clinical studies, refer to the clinical summaries manual for SCS systems. The Proclaim TM SCS System is also the first upgradeable and recharge-free spinal cord stimulation system capable of delivering both tonic stimulation and Abbott's proprietary BurstDR stimulation waveform, a superior therapy designed to more closely mimic how pain signals travel to the brain. In addition to those risks commonly associated with surgery, the following risks are associated with implanting or using this neurostimulation system: Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs; if either occurs, turn off your IPG immediately, 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, Persistent pain at the electrode or IPG site, Seroma (mass or swelling) at the IPG site. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. Before reinserting the sheath, verify there is no damage to the sheath. Poor surgical risks. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. Store components and their packaging where they will not come in contact with liquids of any kind. Read this section to gather important prescription and safety information. 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). 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. If use of electrocautery is necessary, place the neurostimulator in Surgery mode using the clinician programmer app or the patient controller app before using an electrosurgery device. High stimulation outputs. Implantation of this neurostimulation system is contraindicated for the following: Patients for whom test stimulation is unsuccessful. 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). The equipment is not serviceable by the customer. It's small, discreet and available with Abbott's proprietary BurstDR stimulation, a new technology that's clinically proven to . Explosive and flammable gasses. Consumer goods and electronic devices. Needle positioning. 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,. Implanted systems with non-Abbott leads have not been evaluated for safety while scuba diving or in hyperbaric chambers. Before beginning a CT scan, the operator should use CT scout views to determine if implanted or externally worn electronic medical devices are present and if so, their location relative to the programmed scan range. Therapeutic radiation. Closely monitor patients for signs of infection, delayed wound healing, or cerebrospinal fluid (CSF) leakage as the severity of these complications may be greater in patients with diabetes. IPGs contain batteries as well as other potentially hazardous materials. External defibrillation can cause induced currents in the lead-extension portion of the neurostimulation system. Less serious disadvantages of spinal cord stimulation devices include: Fluctuations in stimulation. Scuba diving or hyperbaric chambers. Pregnancy and nursing. Other neurostimulators may restrict the allowed MRI power or scan location, preventing imaging on your shoulders or vital organs in your torso. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. Patient selection. Advancing components. If this date has been reached or has been exceeded before the date of implantation, the generator should be charged prior to implantation. Activities requiring excessive twisting or stretching. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. Therapeutic radiation. Safety has not been established for TMS or ECT in patients who have an implanted neurostimulation system. 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. ** Product materials. 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. All patients are advised to inform their healthcare professional that they should not be exposed to diathermy treatment. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system: Other active implanted devices. Skin erosion. Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. Caution patients to not make unauthorized changes to physician-established stimulation parameters. Risk of depression, suicidal ideations, and suicide. Clinician training. Jude, Medtronic).Most of the early models of these devices were considered MR Unsafe primarily due to the theoretical risk of spinal cord injury from heating of the the electrode tip by RF-induced currents (the so-called antenna effect). Object Category Spinal Cord Stimulation Systems: St. Jude Medical. An expiration date (or use-before date) is printed on the packaging. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. Stimulation effectiveness has been established for one year. 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. Security, antitheft, and radiofrequency identification (RFID) devices. If the lead extensions are routed in a loop, the loop will increase the potential for electromagnetic interference (EMI). IPG placement. Do not use a clinician programmer or patient controller around explosive or flammable gas fumes or vapors. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. The severity of any surgical complication may be greater in patients with diabetes, particularly those with inadequate pre-operative glycemic control. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. Security, antitheft, and radiofrequency identification (RFID) devices. Device modification. Patient's mental capacity, as patients with cognitive impairment or those prone to developing dementia would likely have difficulty performing device-related tasks without assistance. New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. Use extreme care when removing the lead stylet, the delivery sheath, and the needle to ensure that the distal tip of the lead remains in the desired location. For complete guidance, directions, and cautions on MRI safety with a specific device,please review the MRI procedure clinician's manual. Patients should cautiously approach such devices and should request help to bypass them. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. Follow proper infection control procedures. If unpleasant sensations occur, the device should be turned off immediately using the patient magnet. 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. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. 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 at medical.abbott/manuals). Do not use the application if the operating system is compromised (i.e., jailbroken). Nerve damage may result from traumatic or surgical nerve injury. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Infection. Confirm that no adverse conditions to MR scanning are present. 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. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. Interference with other devices. 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. separates the implanted generators to minimize unintended interaction with other system components. Safety and effectiveness of neurostimulation for pediatric use have not been established. Remove the stylet from the lead only when satisfied with lead placement. Recharge-by date. 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. Up to two IPGs, leads, extensions, and burr hole covers may be implanted. Before diving or using a hyperbaric chamber, patients should contact their physician to discuss the effects of high pressure on their implanted system. Do not bend, kink, or stretch the lead body, sheaths, or other components as this may result in damage to the component and poor function. If the implanted system contains components or models not listed in the followingtable, then the system is considered MR Unsafe. January 4, 2022 By Sean Whooley. At the core of this patient-centric advancement is a battery that can last up to 10 years at low-dose settings** without the hassles of recharging. 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. If radiation therapy is required, the area over the implanted generator should be shielded with lead. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems. If needed, return the equipment to Abbott Medical for service. 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. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. Package or component damage. Component handling. Perception of higher levels of stimulation has been described by some patients as uncomfortable, painful, or jolting. Wireless use restrictions. 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. For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. 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). (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Equipment is not serviceable by the customer. Cremation. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. Conditional 5. Always perform removal with the patient conscious and able to give feedback. **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. 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. Conscious sedation. 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. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Confirm the neurostimulation system is functioning correctly after the procedure. A recharge-by date is printed on the packaging. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. Follow proper infection control procedures. Overcommunicating with the IPG.