abbott proclaim spinal cord stimulator mri safety

abbott proclaim spinal cord stimulator mri safetyabbott proclaim spinal cord stimulator mri safety

For adverse effects observed in SCS clinical studies, refer to the clinical summaries manual for SCS systems. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. The Prodigy MRI SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott's smallest implantable pulse generator (IPG). Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Skin erosion. Mobile phones. between lead ends is recommended); Verify that the neurostimulation system is not interfering with the function of the implanted cardiac system; and. Patients should take reasonable care to avoid devices that generate strong EMI, which may cause the neurostimulation system to unintentionally turn on or off. 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. 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. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. INTENDED USE This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. If lithotripsy must be used, do not focus the energy near the generator. Therefore, physicians should consider the following: Preoperatively, assess patients for the risks of depression and suicide. Emergency procedures. Implantation of this neurostimulation system is contraindicated for the following: Patients for whom test stimulation is unsuccessful. Infections may require that the device be explanted. The system is intended to be used with leads and associated extensions that are compatible with the system. We offer products that are MR Conditional for spinal cord stimulation (SCS) and dorsal root ganglion (DRG) therapy. Application modification. Perception of higher levels of stimulation has been described by some patients as uncomfortable, painful, or jolting. Electromagnetic interference (EMI). 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). In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) six to eight weeks after implantation of a neurostimulation system. While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. Unlike other SCS systems, the ProclaimXR SCS system is recharge free. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. To prevent unintended stimulation, do not modify the operating system in any way. High stimulation outputs and charge density limits. Clinician programmers, patient controllers, and chargers are not waterproof. Battery precaution. Nonadjacent leads and extensions have the possibility of creating a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. Bending the sheath. Implantation of multiple leads. To prevent unintended stimulation, do not modify the generator software in any way. Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura. Infections related to system implantation might require that the device be explanted. Explosive and flammable gasses. Patients should cautiously approach such devices and should request help to bypass them. Stimulation effectiveness. An expiration date (or use-before date) is printed on the packaging. Use caution when sedating the patient. Component disposal. Electrosurgery. Scanning under different conditions may cause device malfunction, severe patient injury, or death. Risk of depression, suicidal ideations, and suicide. 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). We know that MRI scans are an important and trusted visualization tooland thats why weve designed our devices and technologies to fit as seamlessly as possible into this critical step in your diagnostic workflow. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Patients should not dive below 30 m (100 ft.) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. To prevent injury or damage to the system, do not modify the equipment. Lead movement. Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. Use care when reinserting a stylet. This damage could result in loss of therapy, requiring additional surgery for system replacement. Infection. All components listed must be implanted unless noted as "optional." The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. Providing strain relief. Additionally, all patients will be awake and conversant during the procedure to minimize the impact. Follow proper infection control procedures. 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. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. The use of high-output devices, such as an electrohydraulic lithotriptor, may damage the electronic circuitry of an implanted generator. Therapeutic magnets (e.g., magnets used in pillows, mattress pads, back belts, knee braces, wrist bands, and insoles) may unintentionally cause the neurostimulation system to turn on or off. 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 Before reinserting the sheath, verify there is no damage to the sheath. Exit Surgery mode during intraoperative testing and after the procedure is completed. Spinal cord stimulation of the dorsal root ganglion for groin pain-a retrospective review. The following precautions apply to this neurostimulation system. To prevent unintended stimulation, do not modify the operating system in any way. 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. Do not crush, puncture, or burn the generator because explosion or fire may result. 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.**. Detailed information on storage environment is provided in the appendix of this manual. 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). Return of symptoms and rebound effect. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. Expiration date. Consumer goods and electronic devices. 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. Surgical advice for removal. All components listed must be implanted unless noted as "optional." Have the patient check the device for proper functioning, even if the device was turned off. Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient. Implantation of two systems. 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. Patients should exercise reasonable caution when bathing. Diathermy is further prohibited because it may also damage the neurostimulation system components. Low frequencies. The severity of any surgical complication may be greater in patients with diabetes, particularly those with inadequate pre-operative glycemic control. 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. For complete and comprehensive MRI support, parameters, and precautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. If a patient experiences new or worsening depression or suicidal ideation, manage these symptoms appropriately. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. 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 (i.e., jailbroken). Remove leads slowly (at a suggested rate of 1 cm/s while holding the lead between the thumb and forefinger) to avoid breaking the lead and leaving fragments in the patient. 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. Programmer use. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. 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. Back pain. 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. The tip of the sheath may whip around and could cause harm to the patient. In the case that a medical treatment is administered where an electrical current is passed through the body from an external source, first deactivate the IPG by setting all electrodes to off, turning stimulation off, and setting amplitude to zero. Unauthorized changes to stimulation parameters. 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. Failure to do so can damage or cut the lead or sheath. Activities requiring coordination. Transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). Patients should cautiously approach such devices and should request help to bypass them. Keep them dry to avoid damage. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) Return the explanted IPG to Abbott Medical. Long-term safety and effectiveness. The effect of mobile phones on deep brain stimulation is unknown. Remove the stylet from the lead only when satisfied with lead placement. Remove leads slowly. Read this section to gather important prescription and safety information. 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. 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. Ultrasonic scanning equipment. Our Invisible Trial System TM is a discreet, app . 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. Batteries can explode, leak, or melt if disassembled, shorted (when battery connections contact metal), or exposed to high temperature or fire. 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. Important note: For CT procedures that require scanning over the medical device continuously for more than a few seconds, as with CT perfusion or interventional exams, attending staff should be ready to take emergency measures to treat adverse reactions if they occur. Failure to do so may cause harm to the patient such as damage to the dura. Wireless use restrictions. 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. 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. If the sheath has been kinked during delivery, slowly retract through the needle with the curve facing the same direction as the bevel. 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. Store components and their packaging where they will not come in contact with liquids of any kind. Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. Implantation of two systems. Up to two IPGs, leads, extensions, and burr hole covers may be implanted. If the implanted system contains components or models not listed in the followingtable, then the system is considered MR Unsafe. If multiple leads or extensions are implanted, the leads and extensions should be routed in close proximity. 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. 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. Safety Topic / Subject Spinal Cord Stimulation (SCS) Systems, Abbott and St. Jude Medical. The system is intended to be used with leads and associated extensions that are compatible with the system. The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. 72784 MAT-2215217 v2.0 | Item approved for U.S. use only. Changes in blood glucose levels in response to any adverse effect Implantation at vertebral levels above T10. Implanted systems with non-Abbott leads have not been evaluated for safety while scuba diving or in hyperbaric chambers. Proclaim XR SCS System Meaningful relief from chronic pain. Sterile components in this kit have been sterilized using ethylene oxide (EtO) gas before shipment and are supplied in sterile packaging to permit direct introduction into the sterile field. 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. For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual. Electromagnetic interference (EMI). 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. Keep the device dry. 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. Patient's age, as very young or very old patients may have difficulty performing required monitoring of the device. Operation of machines, equipment, and vehicles. 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. ), 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.). Additional Disadvantages. Transcutaneous electrical nerve stimulation (TENS). Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient controller. Surgeon training. The following procedures are contraindicated for patients that have been implanted with this device: Diathermy therapy. Nerve damage may result from traumatic or surgical nerve injury. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket. 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). 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. The system is intended to be used with leads and associated extensions that are compatible with the system. Using the tunneling tool. Restricted areas. The Eterna Spinal Cord Stimulation (SCS) System is designed to deliver low-intensity electrical impulses to nerve structures. Diathermy is further prohibited because it may also damage the neurostimulation system components. Use extreme care when using sharp instruments or electrosurgery devices around the lead to avoid damaging the lead. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. 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. Output power below 80 W is recommended for all activations. During the 2000s about a dozen companies sold and manufactured SCS systems worldwide, including the "big three" (Boston Scientific, Abbott/St. When using a contralateral approach, advance the needle slowly into the epidural space and take caution as it enters. Careful consideration should be used before using radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system since safety has not been established. Patients who are unable to properly operate the system. Excessive lead migration may require reoperation to replace the leads. Implant heating. 74373 MAT-2300644 v2.0 | Item approved for U.S. use only. Needle positioning. 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 . Care and handling of components. Skydiving, skiing, or hiking in the mountains. Clinician training. 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. Stabilizing the lead during insertion. 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. Scuba diving or hyperbaric chambers. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. 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. Pediatric use. Do not bend, kink, or use surgical instruments on the stylet, as this may damage it. 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. Falling and other traumatic accidents can damage shallowly implanted components such as the leads and extensions. Some patients may be implanted with the components that make up a Magnetic Resonance (MR) Conditional system, which allows them to receive an MRI scan if all the requirements for the implanted components and for scanning are met. Patient training. 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. Therapeutic magnets. Set the electrosurgery device to the lowest possible energy setting. Component handling. Damage to the system may not be immediately detectable. 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. 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. Patients should not use this neurostimulation system if they are pregnant or nursing. 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. Store components and their packaging where they will not come in contact with liquids of any kind. Electromagnetic interference (EMI). 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. Poor surgical risks. Confirm the neurostimulation system is functioning. Keep them dry to avoid damage. 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. 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. 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. Surgical complications and adverse events may be more frequent and severe in patients with diabetes. This system is contraindicated for patients who meet the following criteria: The following procedures are contraindicated for patients with a deep brain stimulation system.

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