abbott proclaim spinal cord stimulator mri safety

The system is intended to be used with leads and associated extensions that are compatible with the system. Patient selection. Clinician training. Wireless use restrictions. Infection. Advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan. 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. away from the generator and avoid placing any smart device in a pocket near the generator. 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. Poor surgical risks. Nerve damage may result from traumatic or surgical nerve injury. Proclaim XR Spinal Cord Stimulation (SCS) System, Model 3660 and Model 3662 . All patients are advised to inform their healthcare professional that they should not be exposed to diathermy treatment. 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. 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. Neurosurgery Pain Management Orthopaedic Surgery With the Proclaim XR SCS system, you can have hassle-free pain relief with a battery that lasts up to 10 years at low-dose settings* without ever needing to charge the system. Carefully inspect the lead (in the sterile field) for damage after removing it from the sterile package. See Full System Components below if the patient has an IPG and extensions implanted. 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). The operation of the clinician programmer or patient controller could cause them to ignite, causing severe burns, injury, or death. This may occur once the lead is in place and is connected to the neurostimulator and activated. Low frequencies. It is extremely important to select patients appropriately for neurostimulation. 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, cause heating at the lead tip that could result in tissue damage, and induce voltage through the lead that could jolt or shock the patient. If multiple leads are implanted, leads and extensions should be routed in close proximity. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. Patient selection. Advise patients about adverse effects. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. Patients should be advised to not use therapeutic magnets. Conscious sedation during removal. Damage to the system may not be immediately detectable. ), 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.). Make the Bold Choice Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. 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). Do not use excessive pressure when injecting through the sheath. This includes oxygen-enriched environments such as hyperbaric chambers. Patients should avoid activities that may put undue stress on the implanted components of the neurostimulation system. Long-term safety and effectiveness. 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. 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. Have the patient check the device for proper functioning, even if the device was turned off. 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). Do not bring the suture needle in contact with an IPG, lead, or extension, or the component may be damaged. Pregnancy and nursing. The following precautions apply to this neurostimulation system. Removing a kinked sheath. 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. Confirm the neurostimulation system is functioning correctly after the procedure. Up to two IPGs, leads, extensions, and burr hole covers may be implanted. Preventing infection. All components listed must be implanted unless noted as "optional." A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Radiofrequency or microwave ablation. Patient training. Energy from diathermy can be transferred through the implanted system and can cause tissue damage at the location of the implanted electrodes, resulting in a severe injury or death. Security, antitheft, and radiofrequency identification (RFID) devices. This system is contraindicated for patients who meet the following criteria: The following procedures are contraindicated for patients with a deep brain stimulation system. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). For adverse effects observed in SCS clinical studies, refer to the clinical summaries manual for SCS systems. Implanting physicians should be experienced in stereotactic and functional neurosurgery. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. six to eight weeks after implantation of a neurostimulation system. If lithotripsy must be used, do not focus the energy near the IPG. Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. Lasting Relief through our smallest system yet. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system: Other active implanted devices. 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). Number of leads implanted. Use caution when positioning the needle to avoid unintended injury to surrounding anatomical structures. 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. 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. 74372 MAT-2215216 v3.0 | Item approved for U.S. use only. The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. Keep programmers and controllers dry. If lithotripsy must be used, do not focus the energy near the IPG. Lead damage from tools. High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. Single-use, sterile device. PATIENTS If needed, return the equipment to Abbott Medical for service. If the patient requires a CT scan, all stimulation should be turned off before the procedure. Pediatric use. High-output ultrasonics and lithotripsy. Placement of lead connection in neck. Implant heating. Application modification. Changes in blood glucose levels in response to any adverse effect Bathing. For more information about MR Conditional deep brain stimulation (DBS) components and systems, including equipment settings, scanning procedures, and a complete listing of conditionally approved components, refer to the MRI procedures clinician's manual for DBS systems(available online atmedical.abbott/manuals). Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. 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 Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible. 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. For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. If 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. Component handling. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Ensure the patients neurostimulation system is in MRI mode. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. 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. Select patients appropriately for deep brain stimulation. Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura. Battery care. Component manipulation by patients. 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. Neurostimulation should not be used for patients with comorbidities that could prevent successful implant or effective therapy. Electrosurgery. 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. Application modification. IPG placement. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.). Monitor the patients blood glucose levels in the perioperative period and instruct the patient to continue to monitor glucose levels as they may fluctuate as a response to surgery or to complications. 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. After defibrillation, confirm the neurostimulation system is still working. If resistance is encountered, pull the needle out of the epidural space and then remove the sheath. 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. Minimize X-ray exposure to the implanted or externally worn electronic medical device by using the lowest possible X-ray tube current consistent with obtaining the required image quality and by making sure that the X-ray beam does not dwell over the device for more than a few seconds. Nonadjacent leads and extensions have the possibility of creating a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. 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. Explosive and flammable gasses. Read this section to gather important prescription and safety information. 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. External defibrillation can cause induced currents in the lead-extension portion of the neurostimulation system. 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. 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). If the implanted system contains components or models not listed in the followingtable, then the system is considered MR Unsafe. Keep them dry to avoid damage. During the 2000s about a dozen companies sold and manufactured SCS systems worldwide, including the "big three" (Boston Scientific, Abbott/St. Keep dry to avoid damage. The implanted components of this neurostimulation system are intended for a single use only. Sheath insertion precaution. Use extreme care to not damage the lead with the sharp point of the tunneling tool. If unpleasant sensations occur, the device should be turned off immediately. Do not handle the generator if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. The neurostimulator is controlled by a trained operator and the starting point for the stimulation will be set to the lowest available settings. 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). Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. 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 . Stimulation Modes. 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. The clinician programmer and patient controller are not waterproof. 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. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. External defibrillators. Programmer use. Infections related to system implantation might require that the device be explanted. 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. Infections related to system implantation might require that the device be explanted. Approved models and implant locations for an MR Conditional full system, *The IPG port plug associated with these models is also an MR Conditional component. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. 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. 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 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). To prevent unintended stimulation, do not modify the generator software in any way. A recharge-by date is printed on the packaging. Failure to do so may result in damage to the sheath. Confirm implant locations and scan requirements for the patients system. Removing each item in slow movements while holding the remaining components in place will assist this process. Always be aware of the needle tip position. Before opening any sterile package, verify the kit model number, that the kit is within its expiration (use-before) date, and that the packaging has not been damaged or compromised in any way. Package or component damage. The system can be programmed to use parameter settings outside the range of those used in the clinical studies. If the packaging has been compromised, the device is beyond its expiration date, or the sterile package or device show signs of damage, do not use the device as it may be compromised and could cause harm to the patient. Additional Disadvantages. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. 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. Lead handling. Sheath rotation. The patient must be instructed to not rub or exert pressure on implanted components through the skin as this may cause lead dislodgement leading to stimulation at the implant site, IPG inversion leading to the inability to communicate with the device, or skin erosion that can lead to another surgical procedure or possible infection. Recharge-by date. Do not bend, kink, or use surgical instruments on the stylet, as this may damage it. Schu S, Gulve A, ElDabe S, et al. 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. Do not place TENS electrodes so that the TENS current passes over any part of the neurostimulation system. The safety and efficacy of the implantation of greater than four leads have not been evaluated. Using the tunneling tool. 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. 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. Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation. Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinsons disease. Keep the device dry. Physicians should also discuss any risks of MRI with patients. Our Invisible Trial System TM is a discreet, app . 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. Do not use the clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Use caution when sedating the patient. Diathermy is further prohibited because it may also damage the neurostimulation system components. 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. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Safety Info ID# Safety Topic / Subject Article Text 294: Spinal Cord Stimulation Systems: St. Jude Medical: Genesis, GenesisXP, GenesisRC, Eon, Eon C, Eon Mini, and Renew The Genesis, GenesisXP, GenesisRC, Eon, EonC, Eon Mini, and Renew neuromodulation devices (St. Jude Medical) used for spinal cord stimul. 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. Return all explanted IPGs to Abbott Medical for safe disposal. 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. radiofrequency identification (RFID) devices. Application modification. Case damage. Electromagnetic interference (EMI). 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. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief 1. Use extreme care when handling system components. Patients should cautiously approach such devices and should request help to bypass them. 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. Restricted areas. Other neurostimulators may restrict the allowed MRI power or scan location, preventing imaging on your shoulders or vital organs in your torso. If a patient experiences new or worsening depression or suicidal ideation, manage these symptoms appropriately. Device modification. When multiple leads are implanted, route the lead extensions so the area between them is minimized. Output power below 80 W is recommended for all activations. Exposure to body fluids or saline. Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system. Placing the IPG. Removing components. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions. separates the implanted generators to minimize unintended interaction with other system components. 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. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. 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. All components listed must be implanted unless noted as "optional." The Eterna Spinal Cord Stimulation (SCS) System is designed to deliver low-intensity electrical impulses to nerve structures. Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the suppression of disabling upper extremity tremor in adult essential tremor patients whose tremor is not adequately controlled by medications and where the tremor constitutes a significant functional disability. Follow proper infection control procedures. While charging the generator, patients may perceive an increase in temperature at the generator site.