abbott proclaim spinal cord stimulator mri safety

Physicians need to be aware of the risk and possible interaction between a neurostimulation system and an implanted cardiac system, such as a pacemaker or defibrillator. Avoid placing equipment components directly over other electronic devices. Return the explanted IPG to Abbott Medical. Wireless use restrictions. 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. Follow proper infection control procedures. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. Use care when reinserting a stylet. Consider bipolar programming of both devices and use neurostimulation system settings that do not interfere with the function of the implantable cardiac system. 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. For complete and comprehensive MRI support, parameters, and precautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. Lead movement. Operation of machines, equipment, and vehicles. Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinsons disease. A recharge-by date is printed on the packaging. Return all explanted generators to Abbott Medical for safe disposal. 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. 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.). Scuba diving or hyperbaric chambers. This neurostimulation system is contraindicated for patients who are. If unpleasant sensations occur, the device should be turned off immediately using the patient magnet. High-output ultrasonics and lithotripsy. Unauthorized changes to stimulation parameters. Explosive or flammable gasses. 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. Advance the needle and guidewire slowly. 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. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. 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. Postural changes. Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation. Use caution when sedating the patient. The following warnings apply to this neurostimulation system. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. Securing the lead with the lead stabilizer will mitigate this risk. Clinician training. Keep programmers and controllers dry. Do not crush, puncture, or burn the IPG because explosion or fire may result. Unlike other SCS systems, the Proclaim XR SCS system is recharge free. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training. Devices with one-hour recharge per day. 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. Product materials. Stabilizing the lead during insertion. 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. Only apply software updates that are published directly by Abbott Medical. Abbott offers two types of MR Conditional, fully implanted DBS configurations: WARNING: For an MR Conditional system, all implanted components must be approved MR Conditional models. 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. Pain is not resolved. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the location of the implanted electrodes, resulting in severe injury or death. 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. Always perform removal with the patient conscious and able to give feedback. Operation of machines, equipment, and vehicles. If unpleasant sensations occur, turn off stimulation immediately. Ensure the patients neurostimulation system is in MRI mode. Follow proper infection control procedures. Patients should cautiously approach such devices and should request help to bypass them. Implantation of two systems. 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. *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. Sheath retraction. 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. Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible. Do not use surgical instruments to handle the lead. Implanting physicians should be experienced in stereotactic and functional neurosurgery. Infections may require that the device be explanted. 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. Changes in blood glucose levels in response to any adverse effect 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. 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 . 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. Generators contain batteries as well as other potentially hazardous materials. 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. Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target. Damage to the system may not be immediately detectable. Neurostimulation should not be used on patients who are poor surgical candidates. If the lead extensions are routed in a loop, the loop will increase the potential for electromagnetic interference (EMI). 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. The safety and efficacy of implantation of leads implanted above the T10 vertebral level have not been evaluated. Suicidal ideation, suicide attempts, and suicide are events that have also been reported. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. 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. 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. In some cases, symptoms may return with a greater intensity than what a patient experienced before system implantation (rebound effect). Stimulation effectiveness has been established for one year. Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. Patients will receive an identification card to carry with them that will inform emergency medical personnel of their implanted system. Therapeutic radiation. The tip of the sheath may whip around and could cause harm to the patient. The operation of the clinician programmer or patient controller could cause them to ignite, causing severe burns, injury, or death. While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. 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. Scuba diving and hyperbaric chambers. IPG disposal. Both the Intellis and Vanta SCS devices integrate SureScan MRI technology, providing MRI access anywhere in the body with normal operating mode power settings. 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. Package or component damage. Cremation. 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. Patients should avoid charging their generator over an incision that has not completely healed. In addition, a component must be implanted in its approved location as listed in the following table or the entire implanted system is considered MRUnsafe. NOTE: During intraoperative testing, Surgery mode must be turned off for the neurostimulation system to function correctly. The clinician programmer and patient controller are not waterproof. Implanted systems with non-Abbott leads have not been evaluated for safety while scuba diving or in hyperbaric chambers. Scuba diving or hyperbaric chambers. Have the patient check the device for proper functioning, even if the device was turned off. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. Magnetic resonance imaging (MRI). The long-term safety and effectiveness of this neurostimulation system has not been established beyond 5 years. 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. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. 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. Approved models and implant locations for an MR Conditional lead-only system. 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 . Using surgical instruments. Implantation of multiple leads. For less than 30 m (100 ft) of water or pressures below 4.0 ATA, durations of less than 60 minutes are recommended. Bathing. ), 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.). Component handling. Explosive and flammable gasses. Proclaim XR SCS System Meaningful relief from chronic pain. 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). Implantation of this neurostimulation system is contraindicated for the following: Patients for whom test stimulation is unsuccessful. Advancing components. Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. To prevent injury or damage to the system, do not modify the equipment. Implanting physicians or anesthesiologists should consult practice guidelines for the intraoperative management of patients with diabetes. Falling and other traumatic accidents can damage shallowly implanted components such as the leads and extensions. Transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). Application modification. Neurosurgery Pain Management Orthopaedic Surgery Implant heating. Do not use the clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief 1. Removing each item in slow movements while holding the remaining components in place will assist this process. Stimulation Modes. Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. For this reason, programming at frequencies less than 30 Hz is not recommended. Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation. Security, antitheft, and radiofrequency identification (RFID) devices. 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. Transcutaneous electrical nerve stimulation (TENS). 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. radiofrequency identification (RFID) devices. Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura. Do not resterilize or reimplant an explanted system for any reason. Implantation of two systems. The website that you have requested also may not be optimized for your screen size. Handle the device with care. Failure to do so can damage or cut the lead or sheath. 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. If interference occurs, try holding the phone to the other ear or turning off the phone. Electromagnetic interference (EMI). If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. Read this section to gather important prescription and safety information. At the core of this patient-centric advancement is a battery that can last up to 10 years at low-dose settings** without the hassles of recharging. Security, antitheft, and radiofrequency identification (RFID) devices. Patients should avoid activities that may put undue stress on the implanted components of the neurostimulation system. To prevent unintended stimulation, do not modify the operating system in any way. Do not use excessive force to push the lead or sheath into the neural foramen as this may result in permanent or transient nerve damage. Conscious sedation. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the management of disabling tremor. Patients should cautiously approach such devices and should request help to bypass them. Physicians should also discuss any risks of MRI with patients. Removing components. 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. The system is intended to be used with leads and associated extensions that are compatible with the system. Output power below 80 W is recommended for all activations. 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. Use extreme care when using sharp instruments or electrosurgery devices around the lead to avoid damaging the lead. Remove leads slowly. If needed, return the equipment to Abbott Medical for service. Physicians should also discuss any risks of MRI with patients. 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. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.). This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Package or component damage. Do not use a clinician programmer or patient controller around explosive or flammable gas fumes or vapors. Warn patients to seek medical guidance before entering environments that could adversely affect the operation of the implanted device, including areas protected by a warning notice preventing entry by patients fitted with a pacemaker. Poor surgical risks. Confirm implant locations and scan requirements for the patients system. communication equipment (such as microwave transmitters and high-power amateur transmitters). Diathermy is further prohibited because it may also damage the neurostimulation system components. Safety has not been established for TMS or ECT in patients who have an implanted neurostimulation system. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. Batteries can explode, leak, or melt if disassembled, shorted (when battery connections contact metal), or exposed to high temperature or fire. Infection. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). 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. To correct the effects of typical interference, keep wireless communication equipment at least 15 cm (6 in) from the IPG. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Keep them dry to avoid damage. Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. PATIENTS Placement of lead connection in neck. Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. The equipment is not serviceable by the customer. High-output ultrasonics and lithotripsy. Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards. 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. (2) The method of its application or use. These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. Battery care. Surgical complications and adverse events may be more frequent and severe in patients with diabetes. Wireless use restrictions. The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. The implanted components of this neurostimulation system are intended for a single use only. New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. 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. 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. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. 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. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. If the stylet is removed from the lead, it may be difficult to reinsert it. The Eterna Spinal Cord Stimulation (SCS) System is designed to deliver low-intensity electrical impulses to nerve structures. Schu S, Gulve A, ElDabe S, et al. Clinicians should be familiar with deep brain stimulation therapy and be experienced in the diagnosis and treatment of the indication for which the deep brain stimulation components are being used. Free from the hassles of recharging. Securing the anchor. 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. Therapeutic radiation. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. Nonadjacent leads and extensions have the possibility of creating a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. 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. Additional Disadvantages. Do not bend the sheath without the lead inside the sheath, as this will permanently kink it and make it difficult to deploy the lead. 737202011056 v5.0 | Item approved for U.S. use only. maximize the distance between the implanted systems; Use in patients with diabetes. Do not implant a device if the sterile package or components show signs of damage, if the sterile seal is ruptured, or if contamination is suspected for any reason. Patients who failed to receive effective pain relief during trial stimulation are contraindicated to process to the permanent implant procedure. 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. Confirm the neurostimulation system is functioning correctly after the procedure. Package or component damage. However, current data shows that most patients using BurstDR Stimulation Therapy do not experience paresthesia. This system is contraindicated for patients who meet the following criteria: The following procedures are contraindicated for patients with a deep brain stimulation system. Neurostimulation systems have materials that come in contact or may come in contact with tissue. Multiple leads. **Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia as complex regional pain syndrome (CRPS) types I and II, respectively. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. Consumer goods and electronic devices. 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. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. 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. External defibrillation can cause induced currents in the lead-extension portion of the neurostimulation system. 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. Patient's physical ability, as patients with higher degrees of motor impairment might have difficulty with the physical requirements of monitoring the device. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Component disposal. To prevent unintended stimulation, do not modify the generator software in any way. 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.

Tribunal Lay Member Vacancies, Articles A