This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. 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. 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. Note: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. Pressures below 30 m (100 ft.) of water (or above 4.0 ATA) could damage the neurostimulation system. Electrosurgery. Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. Suicidal ideation, suicide attempts, and suicide are events that have also been reported. Implant heating. PATIENTS If the neurostimulator is on during an ECG, the ECG recording may be adversely affected, resulting in inaccurate ECG results. 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). If needed, return the equipment to Abbott Medical for service. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Pregnancy and nursing. Damage to the system may not be immediately detectable. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. 737202011056 v5.0 | Item approved for U.S. use only. Patients should be aware that during skydiving, the sudden jerking that occurs when the parachute opens may cause lead dislodgement or fractures, which may require surgery to repair or replace the lead. Safety and effectiveness of neurostimulation for pediatric use have not been established. The safety and efficacy of implantation of leads implanted above the T10 vertebral level have not been evaluated. Needle insertion. Operating the device near gas fumes or vapors could cause them to catch fire. Spinal cord stimulation of the dorsal root ganglion for groin pain-a retrospective review. Inaccurate ECG results may lead to inappropriate treatment of the patient. Keep them dry to avoid damage. Patients using therapy that generates paresthesia should turn off stimulation before operating motorized vehicles, such as automobiles, or potentially dangerous machinery and equipment because sudden stimulation changes may distract them from properly operating it. Patients should not use this neurostimulation system if they are pregnant or nursing. Do not crush, puncture, or burn the IPG because explosion or fire may result. The severity of any surgical complication may be greater in patients with diabetes, particularly those with inadequate pre-operative glycemic control. Advise patients to not use the patient controller when engaging in activities that might cause it to get wet, such as swimming or bathing. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. 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. Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. Single-use, sterile device. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. 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. Consumer goods and electronic devices. If unpleasant sensations occur, the device should be turned off immediately using the patient magnet. In some cases, symptoms may return with a greater intensity than what a patient experienced before system implantation (rebound effect). While charging the generator, patients may perceive an increase in temperature at the generator site. Return all explanted components to Abbott Medical for safe disposal. Patient's visual ability to read the patient controller screen. 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. Devices with one-hour recharge per day. Activities requiring excessive twisting or stretching. Select patients appropriately for deep brain stimulation. Patients should cautiously approach such devices and should request help to bypass them. 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. Patients should avoid activities that may put undue stress on the implanted components of the neurostimulation system. Advise patients about adverse effects. For less than 30 m (100 ft) of water or pressures below 4.0 ATA, durations of less than 60 minutes are recommended. 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. Ensure the neurostimulator is off before initiating an electrocardiogram (ECG). Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control. Inserting the anchor. Do not over-manipulate the sheath and lead system as this may result in trauma within the epidural space. This system is contraindicated for patients who meet the following criteria: The following procedures are contraindicated for patients with a deep brain stimulation system. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. Pediatric use. Device modification. The system is intended to be used with leads and associated extensions that are compatible with the system. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. Skydiving, skiing, or hiking in the mountains. The implanted components of this neurostimulation system are intended for a single use only. 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. 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. Activities requiring coordination. Neurostimulation systems have materials that come in contact or may come in contact with tissue. Transcutaneous electrical nerve stimulation (TENS). 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. Operation of machines, equipment, and vehicles. The neurostimulator is controlled by a trained operator and the starting point for the stimulation will be set to the lowest available settings. Neurostimulation should not be used on patients who are poor surgical candidates. Patients should not dive below 30 m (100 ft.) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). 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). If the implanted system contains any other components or models than what appears in the following tables, then the system is considered untested for an MRI environment. In addition to those risks commonly associated with surgery, the following risks are associated with using this neurostimulation system: Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your generator immediately.). All patients are advised to inform their healthcare professional that they should not be exposed to diathermy treatment. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. IPG placement. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. The Proclaim XR SCS system can provide relief to . Recharge-by date. Handle the programmers and controllers with care. 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. Use caution when securing the soft tissue anchor because damage to the anchor or lead can occur and result in failure of the system. Electromagnetic interference (EMI). Bathing. FDA's expanded . All components listed must be implanted unless noted as "optional." Confirm implant locations and scan requirements for the patients system. Product materials. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief. Loss of coordination is a potential side effect of DBS therapy. IPG disposal. Device modification. The following warnings apply to this neurostimulation system. High-output ultrasonics and lithotripsy. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. Control of the patient controller. If lithotripsy must be used, do not focus the energy near the IPG. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. However, current data shows that most patients using BurstDR stimulation therapy do not experience paresthesia. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Caution patients to not make unauthorized changes to physician-established stimulation parameters. 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. Failure to do so may cause harm to the patient such as damage to the dura. Stimulation effectiveness has been established for one year. To prevent unintended stimulation, do not modify the operating system in any way. These activities include but are not limited to climbing ladders and operating potentially dangerous machinery, power tools, and vehicles. Implantation at vertebral levels above T10. 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. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. Before diving or using a hyperbaric chamber, patients should contact their physician to discuss the effects of high pressure on their implanted system. Sheath retraction. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. For complete MRI guidance, parameters and cautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. Detailed information on storage environment is provided in the appendix of this manual. Confirm the neurostimulation system is functioning. 72750 MAT-2215018 v2.0 | Item approved for U.S. use only. Always perform removal of implanted components with the patient conscious and able to give feedback. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. Set the electrosurgery device to the lowest possible energy setting. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. 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. 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. External defibrillators. 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. Lasting Relief through our smallest system yet. Use extreme care to not damage the lead with the sharp point of the tunneling tool. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Operation of machines, equipment, and vehicles. 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. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient controller. Object Category Spinal Cord Stimulation Systems: St. Jude Medical. It's small, discreet and available with Abbott's proprietary BurstDR stimulation, a new technology that's clinically proven to . This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. Scuba diving or hyperbaric chambers. Follow proper infection control procedures. Coagulopathies. Electromagnetic interference (EMI). If the stylet is removed from the lead, it may be difficult to reinsert it. Radiofrequency or microwave ablation. Use care when reinserting a stylet. Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. The abrupt cessation of stimulation for any reason will probably cause disease symptoms to return. High stimulation outputs and charge density limits. After any surgery, check the neurostimulation system for the following: Check the neurostimulator to ensure Surgery mode has been turned off, even if Surgery mode was not turned on at the beginning or during the procedure. Implantation of multiple leads. Advise patients who experience these types of stimulation changes to turn down the amplitude or turn off the IPG before making extreme posture changes or abrupt movements such as stretching, lifting their arms over their heads, or exercising. High stimulation outputs. Clinician training. Patients should avoid charging their generator over an incision that has not completely healed. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. Electrosurgery. Stimulation Modes. 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. Scanning under different conditions may cause device malfunction, severe patient injury, or death. 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. External defibrillation can cause induced currents in the leadextension portion of the neurostimulation system. 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. Back pain. Use extreme care when handling system components. 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. Stimulation effectiveness. The following precautions apply to this neurostimulation system. Before reinserting the sheath, verify there is no damage to the sheath. Clinician programmers, patient controllers, and chargers are not waterproof. Application modification. Implantation of two systems. Anchoring leads. If multiple leads or extensions are implanted, the leads and extensions should be routed in close proximity. Other active implantable devices. 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.**. Risk of depression, suicidal ideations, and suicide. 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. Security, antitheft, and radiofrequency identification (RFID) devices. The IPG should be explanted before cremation because the IPG could explode. Stabilizing the lead during insertion. January 4, 2022 By Sean Whooley. 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. 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. 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. To prevent unintended stimulation, do not modify the generator software in any way. separates the implanted IPGs to minimize unintended interaction with other system components. Generators contain batteries as well as other potentially hazardous materials. 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. 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. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. Unauthorized changes to stimulation parameters. radiofrequency identification (RFID) devices. 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. Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment. 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. If a system does not meet the MR Conditional requirements, consider it MR Unsafe. Lead inspection. 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. Sources of therapeutic radiation include therapeutic X-rays, cobalt machines, and linear accelerators. 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. Abbott recently received new FDA-approved labeling which expands MRI compatibility with the leads used on the Proclaim TM XR Spinal Cord Stimulation System. See Full System Components below if the patient has an IPG and extensions implanted. Patients should be advised to not use therapeutic magnets. away from the generator and avoid placing any smart device in a pocket near the generator. Do not handle the generator if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) 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. Wireless use restrictions. Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the management of disabling tremor. Poor surgical risks. 74373 MAT-2300644 v2.0 | Item approved for U.S. use only. Storage environment. 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. 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. Poor surgical risks. Wireless use restrictions. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Batteries can explode, leak, or melt if disassembled, shorted (when battery connections contact metal), or exposed to high temperature or fire. Schu S, Gulve A, ElDabe S, et al. Household appliances. Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards. Patients should be advised to avoid carrying mobile phones in their shirt pocket or otherwise placing them directly over the deep brain stimulation system components. During the implant procedure, if an electrosurgery device must be used, take the following actions:. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Patient selection. Advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan. Do not crush, puncture, or burn the IPG because explosion or fire may result. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. 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. Use extreme care when handling system components prior to implantation. Physicians should also discuss any risks of MRI with patients. Patients who failed to receive effective pain relief during trial stimulation are contraindicated to process to the permanent implant procedure. Surgical complications and adverse events may be more frequent and severe in patients with diabetes. between lead ends is recommended); Verify that the neurostimulation system is not interfering with the function of the implanted cardiac system; and. Scuba diving or hyperbaric chambers. Do not use the system if the use-before date has expired. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Return all explanted IPGs to Abbott Medical for safe disposal. *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.
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abbott proclaim spinal cord stimulator mri safety