The following precautions apply to this neurostimulation system. Patients should not dive below 30 m (100 ft.) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Use extreme care when handling system components prior to implantation. Component manipulation. To prevent injury or damage to the system, do not modify the equipment. A risk of brain tissue damage exists with parameter settings using high amplitudes and wide pulse widths. 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), radiofrequency identification (RFID) devices, some medical procedures (such as therapeutic radiation, static magnetic field [SMF] therapy, and electromagnetic lithotripsy), and some medical devices (such as bone growth stimulators, transcutaneous electrical nerve stimulation [TENS] devices, dental drills, and ultrasonic probes). High stimulation outputs. Before reinserting the sheath, verify there is no damage to the sheath. This damage could result in loss of therapy, requiring additional surgery for system replacement. Abbott's neurostimulation therapies are designed to alter those signals as they travel to the brain, and minimize how you perceive pain.3 PROVEN SAFE AND EFFECTIVEWITH BENEFITS BEYOND PAIN RELIEF2, 4 One of the advantages of neurostimulation is that you can try the therapy using a temporary system before committing to an implanted system. Do not use excessive force to push the lead or sheath into the neural foramen as this may result in permanent or transient nerve damage. 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. Low frequencies. Prior to connection, exposure of the metal contacts, such as those on the connection end of a lead or extension, to body fluids or saline can lead to corrosion. Implantation of two systems. Lasting Relief through our smallest system yet. Implantation at vertebral levels above T10. Operation of machines, equipment, and vehicles. Removing a kinked sheath. 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. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. Confirm that the neurostimulation system is functioning correctly during the implant procedure, before closing the neurostimulator pocket, and after the implant procedure. To find Shipping Material Packaging Waste information, select Healthcare Professionals. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. 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 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 includes oxygen-enriched environments such as hyperbaric chambers. Implantation of two systems. 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. 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. 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. High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. Mobile phones. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. 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. Patient's physical ability, as patients with higher degrees of motor impairment might have difficulty with the physical requirements of monitoring the device. Free from the hassles of recharging. 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. Other active implantable devices. 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. In some cases, symptoms may return with a greater intensity than what a patient experienced before system implantation (rebound effect). January 4, 2022 By Sean Whooley. Remove leads slowly. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. 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. 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. 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. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. 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. Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the neurostimulation system. Safety Topic / Subject Spinal Cord Stimulation (SCS) Systems, Abbott and St. Jude Medical. Handle the device with care. 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. During the implant procedure, if an electrosurgery device must be used, take the following actions:. Battery precaution. New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. Sheath insertion precaution. Ask patients with neurostimulators to shut off the device temporarily while the scan is performed. Consumer goods and electronic devices. If two systems are implanted, ensure that at least 20 cm (8 in.) 72750 MAT-2215018 v2.0 | Item approved for U.S. use only. Infections related to system implantation might require that the device be explanted. Expected effect from cessation of therapy, should disease symptoms return unexpectedly. Electrocardiograms. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system. If unpleasant sensations occur, turn off stimulation immediately. 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. 2013;16(5):471-482. The Eterna Spinal Cord Stimulation (SCS) System is designed to deliver low-intensity electrical impulses to nerve structures. The long-term safety and effectiveness of this neurostimulation system has not been established beyond 5 years. Advise patients to inform their healthcare professional that they cannot undergo the following procedures: Diathermy (short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy), Electroshock therapy and transcranial magnetic stimulation (TMS). Placement of lead connection in neck. Store components and their packaging where they will not come in contact with liquids of any kind. ** Use extreme care to not damage the lead with the sharp point of the tunneling tool. Up to two leads, lead protection boots, and burr hole covers may be implanted. Lead movement. Equipment is not serviceable by the customer. Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target. Component disposal. 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. 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. 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. 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 a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. Physicians should also consider underlying factors, such as previous neurological injury or prescribed medications (anticoagulants), that may predispose a patient to the risk of bleeding. Do not use the application if the operating system is compromised (that is, jailbroken). Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Return any suspect components to Abbott Medical for evaluation. Neurostimulation should not be used for patients with comorbidities that could prevent successful implant or effective therapy. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. away from the generator and avoid placing any smart device in a pocket near the generator. Use extreme care when handling system components. The neurostimulator is controlled by a trained operator and the starting point for the stimulation will be set to the lowest available settings. 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. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. Return them to Abbott Medical for proper disposal. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. Removing components. Maximize the distance between the implanted systems (minimum separation distance of approximately 8 cm (3 in.) To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the location of the implanted electrodes, resulting in severe injury or death. 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. 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,. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. The safety and efficacy of implantation of leads implanted above the T10 vertebral level have not been evaluated. Do not implant a device if the sterile package, the device, or any device components show signs of damage, tampering, or if the sterile seal is ruptured, or contamination is suspected for any reason. Scuba diving or hyperbaric chambers. Package or component damage. Neurostimulation systems have materials that come in contact or may come in contact with tissue. This assessment should consider both the risk of depression and suicide as well as the potential clinical benefits of DBS therapy for the condition being treated. Back pain. Therapeutic radiation. Needle positioning. away from the generator and avoid placing any smart device in a pocket near the generator. 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. However, current data shows that most patients using BurstDR Stimulation Therapy do not experience paresthesia. Component manipulation by patients. Wireless use restrictions. The system is intended to be used with leads and associated extensions that are compatible with the system. High-output ultrasonics and lithotripsy. Advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan. Battery care. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. Do not use excessive pressure when injecting through the sheath. WARNING:For a neurostimulation system to be MR Conditional, all implanted components must be approved MR Conditional models and implanted in approved locations according to the following table. PATIENTS Return all explanted components to Abbott Medical for safe disposal. 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. 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. For this reason, programming at frequencies less than 30 Hz is not recommended. For more information, see the clinician programmer manual. Surgical advice for removal. Programmer use. Sheath insertion warning. Follow proper infection control procedures. Proclaim XR Spinal Cord Stimulation (SCS) System, Model 3660 and Model 3662 . 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. Single-use, sterile device. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. 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. An expiration date (or use-before date) is printed on the packaging. Keep the device dry. 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. Diathermy is further prohibited because it may also damage the neurostimulation system components. Implant heating. Needle insertion. 72784 MAT-2215217 v2.0 | Item approved for U.S. use only. Securing the anchor. Patients should cautiously approach such devices and should request help to bypass them. Restricted areas. Control of the patient controller. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Exposure to body fluids or saline. Do not resterilize or reimplant an explanted system for any reason. Use fluoroscopy and extreme care when inserting, advancing, or manipulating the guidewire or lead in the epidural space to minimize the risk of a dural tear. Inaccurate ECG results may lead to inappropriate treatment of the patient. Warn patients to seek medical guidance before entering environments that could adversely affect the operation of the implanted device, including areas protected by a warning notice preventing entry by patients fitted with a pacemaker. Computed tomography (CT). Schu S, Gulve A, ElDabe S, et al. 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. 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). Use caution when positioning the needle to avoid unintended injury to surrounding anatomical structures. IPGs contain batteries as well as other potentially hazardous materials. Patient selection. During the 2000s about a dozen companies sold and manufactured SCS systems worldwide, including the "big three" (Boston Scientific, Abbott/St. Advise patients about adverse effects. PDF View Shellock R & D Services, Inc. email: . Stimulation Modes. Ensure the patients neurostimulation system is in MRI mode. Sources of therapeutic radiation include therapeutic X-rays, cobalt machines, and linear accelerators. Device components. Interference with wireless equipment. 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. Patient's age, as very young or very old patients may have difficulty performing required monitoring of the device. Removing each item in slow movements while holding the remaining components in place will assist this process. Use caution when securing the soft tissue anchor because damage to the anchor or lead can occur and result in failure of the system. Conscious sedation during removal. 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. Explosive and flammable gasses. Changes in blood glucose levels in response to any adverse effect 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 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. Electrical medical treatment. Patients should cautiously approach such devices and should request help to bypass them. 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. 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). Up to two IPGs, leads, extensions, and burr hole covers may be implanted. The tip of the sheath may whip around and could cause harm to the patient. 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. 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. 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. Implanting physicians or anesthesiologists should consult practice guidelines for the intraoperative management of patients with diabetes. If two systems are implanted, ensure that at least 20 cm (8 in) separates the implanted IPGs to minimize unintended interaction with other system components. Surgical complications and adverse events may be more frequent and severe in patients with diabetes. In rare cases, this can create a medical emergency. If radiation therapy is required, the area over the implanted generator should be shielded with lead. Product materials. Consumer goods and electronic devices. Using surgical instruments. 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). Failure to do so may cause harm to the patient such as damage to the dura. Caution patients to not make unauthorized changes to physician-established stimulation parameters. It's small, discreet and available with Abbott's proprietary BurstDR stimulation, a new technology that's clinically proven to . When inserting the lead-sheath assembly through the needle into the epidural space, tighten the lead stabilizer to prevent lead migration out of the sheath. 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. Electrosurgery. Consider bipolar programming of both devices and use neurostimulation system settings that do not interfere with the function of the implantable cardiac system. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. 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. radiofrequency identification (RFID) devices. Infection. Wireless use restrictions. Lead movement. Patients should avoid activities that may put undue stress on the implanted components of the neurostimulation system. Advise patients to inform their healthcare professional that they should not be exposed to diathermy treatment. Electromagnetic interference (EMI). Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards. 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. Before your patient undergoes an MRI scan: Confirm the MR Conditional components and location of the system. Exposure to body fluids or saline. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia). 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. When multiple leads are implanted, route the lead extensions so the area between them is minimized. If gas fumes or vapors catch fire, it could cause severe burns, injury, or death. 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. Especially consider the following additional factors when selecting patients: Level of available support from a caregiver. Pediatric use. Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation. Do not implant a device if the sterile package or components show signs of damage, if the sterile seal is ruptured, or if contamination is suspected for any reason. 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. Only apply software updates that are published directly by Abbott Medical. Programmer and controller devices are not waterproof. Patient activities and environmental precautions. The operation of the clinician programmer or patient controller could cause them to ignite, causing severe burns, injury, or death. 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. Unauthorized changes to stimulation parameters. If the patient requires a CT scan, all stimulation should be turned off before the procedure. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Operation of machinery and equipment. Explosive or flammable gasses. Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. Place the neurostimulator in Surgery mode before using an electrosurgery device. 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). Recharge-by date. Radiofrequency or microwave ablation. Do not over-manipulate the sheath and lead system as this may result in trauma within the epidural space. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. Safety has not been established for TMS or ECT in patients who have an implanted neurostimulation system. (2) The method of its application or use. Do not use the system if the use-before date has expired. 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. Activities requiring excessive twisting or stretching. Conversely, the other active implanted device may interfere with the operation of the neurostimulation system. Lead damage from tools. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. The Eterna SCS System is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation. Do not suture directly onto the lead to avoid damaging the lead. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) If lithotripsy must be used, do not focus the energy near the IPG. The long-term safety associated with multiple implants, leads left in place without use, replacement of leads, multiple implants into the target structure, and lead explant is unknown. 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. 71409MAT-2116350 v4.0 | Item approved for U.S. use only. ); 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. Use extreme care when using sharp instruments or electrosurgery devices around the lead to avoid damaging the lead. Patients without an MR Conditional neurostimulation system should not be subjected to MRI because the electromagnetic field generated by an MRI may damage the device electronics and induce voltage through the lead that could jolt or shock the patient.
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