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

Therefore, physicians should consider the following: Preoperatively, assess patients for the risks of depression and suicide. Poor surgical risks. Activities requiring excessive twisting or stretching. Physicians should also discuss any risks of MRI with patients. Sheath retraction. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. Read this section to gather important prescription and safety information. Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. Pressures below 30 m (100 ft.) of water (or above 4.0 ATA) could damage the neurostimulation system. Patient training. 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. Patients should cautiously approach such devices and should request help to bypass them. Use extreme care when handling system components prior to implantation. If needed, return the equipment to Abbott Medical for service. 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. 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 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. Patients should not be dependent on drugs and should be able to operate the neurostimulation system. 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 coordination. 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. The use of components not approved for use by Abbott Medical with this system may result in damage to the system and increased risk to the patient. Keep programmers and controllers dry. Diathermy is further prohibited because it may also damage the neurostimulation system components. Carefully inspect the lead (in the sterile field) for damage after removing it from the sterile package. 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. Devices with one-hour recharge per day. Conscious sedation. 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. Stimulation effectiveness. Patient training. Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment. It is extremely important to select patients appropriately for neurostimulation. All patients are advised to inform their healthcare professional that they should not be exposed to diathermy treatment. Damage to the system may not be immediately detectable. 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. Case damage. However, some patients may experience a decrease or increase in the perceived level of stimulation. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. Higher amplitudes and wider pulse widths may indicate a system problem or a suboptimal lead placement. If unpleasant sensations occur, the IPG should be turned off immediately. Infection. Falling and other traumatic accidents can damage shallowly implanted components such as the leads and extensions. For more information about MR Conditional products, visit the Abbott Medical product information page atneuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. 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). Proclaim XR Spinal Cord Stimulation (SCS) System, Model 3660 and Model 3662 . Avoid placing equipment components directly over other electronic devices. If lithotripsy must be used, do not focus the energy near the IPG. 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. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. 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. Our Invisible Trial System TM is a discreet, app . Patient selection. 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. 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, which are implanted, electrically insulated wires that transmit electrical impulses to the target nerves If radiation therapy is required, the area over the implanted generator should be shielded with lead. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or render the patient incapable of controlling the generator. Risk of depression, suicidal ideations, and suicide. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. 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. Use extreme care when removing the lead stylet, the delivery sheath, and the needle to ensure that the distal tip of the lead remains in the desired location. After CT scanning directly over the implanted or externally worn electronic medical device: Have the patient turn the device back on if it had been turned off prior to scanning. Keep them dry to avoid damage. If unpleasant sensations occur, the device should be turned off immediately. Stabilizing the lead during insertion. 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. between lead ends is recommended); Verify that the neurostimulation system is not interfering with the function of the implanted cardiac system; and. To prevent injury or damage to the system, do not modify the equipment. Computed tomography (CT). Long-term safety and effectiveness. Up to two leads, lead protection boots, and burr hole covers may be implanted. Do not crush, puncture, or burn these devices because explosion or fire may result. Return all explanted components to Abbott Medical for safe disposal. Application modification. Low frequencies. All components listed must be implanted unless noted as "optional." 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. Radiofrequency or microwave ablation. Conditional 5. Both the Intellis and Vanta SCS devices integrate SureScan MRI technology, providing MRI access anywhere in the body with normal operating mode power settings. Clinician training. Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Do not use the application if the operating system is compromised (i.e., jailbroken). Safety Topic / Subject Spinal Cord Stimulation (SCS) Systems, Abbott and St. Jude Medical. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. The force of the instruments may damage the lead or stylet. 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. Poor surgical risks. Lead insertion through sheath. Storage environment. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. Unlike other SCS systems, the ProclaimXR SCS system is recharge free. 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). Unlike other SCS systems, the Proclaim XR SCS system is recharge free. Do not resterilize or reimplant an explanted system for any reason. 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. Damage to the system may not be immediately detectable. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. Do not use the application if the operating system is compromised (that is, jailbroken). Expiration date. Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura. Schu S, Gulve A, ElDabe S, et al. Patients should cautiously approach such devices and should request help to bypass them. Remove leads slowly. The Eterna Spinal Cord Stimulation (SCS) System is designed to deliver low-intensity electrical impulses to nerve structures. Explosive or flammable gasses. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. Confirm the neurostimulation system is functioning correctly after the procedure. Advance the needle and guidewire slowly. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems (available online at medical.abbott/manuals). The placement of the leads involves some risk, as with any surgical procedure. 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. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Patients should also avoid any activities that would be potentially unsafe if their symptoms were to return unexpectedly. Up to two IPGs, leads, extensions, and burr hole covers may be implanted. separates the implanted generators to minimize unintended interaction with other system components. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief. Security, antitheft, and radiofrequency identification (RFID) devices. 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. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. Sources of therapeutic radiation include therapeutic X-rays, cobalt machines, and linear accelerators. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). 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. Component handling. ), 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.). Anchoring leads. 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,. If multiple leads or extensions are implanted, the leads and extensions should be routed in close proximity. 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. Diathermy is further prohibited because it may also damage the neurostimulation system components. Postural changes. Care and handling of components. Use extreme care when using sharp instruments or electrosurgery devices around the lead to avoid damaging the lead. 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. Especially consider the following additional factors when selecting patients: Level of available support from a caregiver. Poor surgical risks. This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Mobile phones. Detailed information on storage environment is provided in the appendix of this manual. Keep them dry to avoid damage. For more information, see the clinician programmer manual. 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. Loss of coordination is a potential side effect of DBS therapy. Implant heating. Storage environment. 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 be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for at least six weeks after implantation. Transcutaneous electrical nerve stimulation (TENS). Handle the device with care. Advancing components. Do not over-manipulate the sheath and lead system as this may result in trauma within the epidural space. Operating the device near gas fumes or vapors could cause them to catch fire. In addition to those risks commonly associated with surgery, the following risks are associated with implanting or using this neurostimulation system: Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs; if either occurs, turn off your IPG immediately, Undesirable changes in stimulation, which may be related to cellular changes in tissue around the electrodes, changes in electrode position, loose electrical connections, or lead failure, Persistent pain at the electrode or IPG site, Seroma (mass or swelling) at the IPG site. Recharge-by date. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Stylet handling. 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). When using a contralateral approach, advance the needle slowly into the epidural space and take caution as it enters. Exposure of the metal contacts, such as those on the connection end of a lead or extension, to body fluids or saline prior to connection can lead to corrosion. 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. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Surgical complications and adverse events may be more frequent and severe in patients with diabetes. The implanted components of this neurostimulation system are intended for a single use only. High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. Additionally, all patients will be awake and conversant during the procedure to minimize the impact. If interference occurs, try holding the phone to the other ear or turning off the phone. The neurostimulation system is indicated for the following conditions: Bilateral stimulation of the subthalamic nucleus (STN) or the internal globus pallidus (GPi) as an adjunctive therapy to reduce some of the symptoms of advanced levodopa-responsive Parkinsons disease that are not adequately controlled by medications. We offer products that are MR Conditional for spinal cord stimulation (SCS) and dorsal root ganglion (DRG) therapy. Consider bipolar programming of both devices and use neurostimulation system settings that do not interfere with the function of the implantable cardiac system. Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation. 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 . Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards. Coagulopathies. Return any suspect components to Abbott Medical for evaluation. Device modification. 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. 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. Ensure the patients neurostimulation system is in MRI mode. Preventing infection. The IPG should be explanted before cremation because the IPG could explode. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. The needle will be inserted at a steeper angle than in an antegrade approach and there is a greater chance of dural puncture that will lead to a cerebrospinal fluid leak. If the implanted system contains components or models not listed in the followingtable, then the system is considered MR Unsafe. 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. Handle the programmers and controllers with care. Securing the lead with the lead stabilizer will mitigate this risk. 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. Instruct patients to designate a representative (family member or close friend) to notify any emergency medical personnel of their implanted neurostimulation system if emergency care is required. 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. Removing components. External defibrillators. 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. Patients should not dive below 30 m (100 ft) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). The equipment is not serviceable by the customer. 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. Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control. To prevent injury or damage to the system, do not modify the equipment. Use caution when securing the soft tissue anchor because damage to the anchor or lead can occur and result in failure of the system. Keep dry to avoid damage. Interference with other devices. Insertion of a sheath without the lead may result in dural puncture. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. The Proclaim XR implantable pulse generator (IPG) is a novel device designed to supply low-dose BurstDR stimulation in a primary cell battery guaranteed to last 5-10 years with appropriate programming. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. Package or component damage. Return any suspect components to Abbott Medical for evaluation. Patients who failed to receive effective pain relief during trial stimulation are contraindicated to process to the permanent implant procedure. The safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established. 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. 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. If the operating field is bloody, wipe gloves, lead, stylet, and sheath before handling the lead. New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. Product materials. Implantation at vertebral levels above T10. Component manipulation by patients. Surgeon training. Conscious sedation during removal. Abandoned leads and replacement leads. separates the implanted IPGs to minimize unintended interaction with other system components. To correct the effect of interference with other devices, turn off the equipment or increase the distance between the equipment and the device being affected. Pediatric use. 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. 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.). In some cases, symptoms may return with a greater intensity than what a patient experienced before system implantation (rebound effect). Output power below 80 W is recommended for all activations. 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.