72188 MAT-2214515 v1.0 | Item approved for U.S. use only. For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. Lead 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). 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. 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. Higher amplitudes and wider pulse widths may indicate a system problem or a suboptimal lead placement.
Do not crush, puncture, or burn the IPG because explosion or fire may result. Poor surgical risks. Radiofrequency or microwave ablation. If gas fumes or vapors catch fire, it could cause severe burns, injury, or death. The Proclaim XR SCS System is an implantable spinal cord stimulation device designed to allow patients to attain relief from chronic pain of the trunk and limbs. Sheath rotation. If this date has been reached or has been exceeded before the date of implantation, the generator should be charged prior to implantation. Keep them dry to avoid damage. Always perform removal with the patient conscious and able to give feedback. Application modification. The following procedures are contraindicated for patients that have been implanted with this device: Diathermy therapy. A recharge-by date is printed on the packaging. Do not bend, kink, or use surgical instruments on the stylet, as this may damage it. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for at least six weeks after implantation. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Patients who failed to receive effective pain relief during trial stimulation are contraindicated to process to the permanent implant procedure. Keep them dry to avoid damage. Do not crush, puncture, or burn the generator because explosion or fire may result. 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. Operation of machines, equipment, and vehicles. The operation of these devices could cause them to ignite, causing severe burns, injury, or death. Consider bipolar programming of both devices and use neurostimulation system settings that do not interfere with the function of the implantable cardiac system. During implant procedures, if electrosurgery devices must be used, take the following actions: Complete any electrosurgery procedures before connecting the leads or extensions to the neurostimulator. 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. If needed, return the equipment to Abbott Medical for service. Computed tomography (CT). Care and handling of components.
Proclaim DRG System | Abbott Keep programmers and controllers dry. Component disposal. Patients should cautiously approach such devices and should request help to bypass them. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Return all explanted generators to Abbott Medical for safe disposal. Pediatric use. The website that you have requested also may not be optimized for your screen size. Up to two leads, lead protection boots, and burr hole covers may be implanted. Security, antitheft, and radiofrequency identification (RFID) devices. Patients should not use this neurostimulation system if they are pregnant or nursing. Component manipulation. maximize the distance between the implanted systems; Use in patients with diabetes. Back pain. 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. Diathermy is further prohibited because it may also damage the neurostimulation system components. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Emergency procedures. 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. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Storage environment. 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. 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. After defibrillation, confirm the neurostimulation system is still working. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) **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. 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. Bending the sheath. Component manipulation by patients. Patients who are unable to properly operate the system. Battery precaution. away from the generator and avoid placing any smart device in a pocket near the generator. 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. Unwanted changes in stimulation may include a jolting or shocking feeling. New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. 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. Confirm that no adverse conditions to MR scanning are present. communication equipment (such as microwave transmitters and high-power amateur transmitters). Other active implantable devices. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. Precision Spectra Spinal Cord Stimulator System Innovation Focused on Pain Relief Designed for more coverage, more flexibility, and advanced control, the Precision Spectra SCS System is engineered to provide more pain relief to a broader spectrum of patients. Physicians should also discuss any risks of MRI with patients. Store components and their packaging where they will not come in contact with liquids of any kind. Failure to do so can damage or cut the lead or sheath. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system: Other active implanted devices. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. away from the generator and avoid placing any smart device in a pocket near the generator. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Stabilizing the lead during insertion. Avoid placing equipment components directly over other electronic devices. Lead inspection. Patients should avoid activities that may put undue stress on the implanted components of the neurostimulation system. 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. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. Application modification. Advancing components. WARNING:For a neurostimulation system to be MR Conditional, all implanted components must be approved MR Conditional models and implanted in approved locations according to the following table. Do not use the clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. If the stylet is removed from the lead, it may be difficult to reinsert it. 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. Inaccurate ECG results may lead to inappropriate treatment of the patient. Deep brain stimulation complications include, but are not limited to, the following: Undesirable changes in stimulation related to cellular changes in tissue around the electrodes, changes in the electrode position, loose electrical connections, or lead fracture, Loss of therapeutic benefit as a result of change in electrode positions, loose electrical connections, or lead or extension fracture, Initial jolt or tingling during stimulation; jolting or shocking sensations, Lead fracture, migration, or dislodgement, Extension malfunction, fracture, or disconnect, Deep brain stimulation system failure or battery failure within the device, Deep brain stimulation system malfunction or dislodgement, Allergic or rejection response to implanted materials, Persistent pain, tightness, or redness at the incision sites or general pain, General erosion or local skin erosion over the IPG, Persistent pain, tightness, or discomfort around the implanted parts (e.g., along the extension path in the neck), Impaired wound healing (e.g., incision site drainage) or abscess formation, Additional neurosurgical procedure to manage one of the above complications or to replace a malfunctioning component, Stimulation-related complications or other complications, Worsening of motor impairment and Parkinsons disease symptoms including dyskinesia, rigidity, akinesia or bradykinesia, myoclonus, motor fluctuations, abnormal gait or incoordination, ataxia, tremor, and dysphasia, Paresis, asthenia, hemiplegia, or hemiparesis, Sensory disturbance or impairment including neuropathy, neuralgia, sensory deficit, headache, and hearing and visual disturbance, Speech or language impairment including, aphasia, dysphagia, dysarthria, and hypophonia, Cognitive impairment including attention deficit, confusion, disorientation, abnormal thinking, hallucinations, amnesia, delusions, dementia, inability to act or make decisions, psychic akinesia, long term memory impairment, psychiatric disturbances, depression, irritability or fatigue, mania or hypomania, psychosis, aggression, emotional lability, sleep disturbance, anxiety, apathy, drowsiness, alteration of mentation, postural instability and disequilibrium, Cardiac dysfunction (e.g., hypotension, heart rate changes, or syncope), Eye disorder including eye apraxia or blepharospasm, (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. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Do not use a clinician programmer or patient controller around explosive or flammable gas fumes or vapors. Before reinserting the sheath, verify there is no damage to the sheath. Learn more about the scan details for our MR Conditional products below. FDA's expanded . Electromagnetic interference (EMI). Pregnancy and nursing. Use extreme care when using sharp instruments or electrosurgery devices around the lead to avoid damaging the lead. Mobile phones. Remove the stylet from the lead only when satisfied with lead placement. Advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan. Keep dry to avoid damage. Failure to provide strain relief may result in lead migration requiring a revision procedure. Infections related to system implantation might require that the device be explanted. Removing each item in slow movements while holding the remaining components in place will assist this process. Instruct patients to use their neurostimulation system only after an authorized clinician has programmed the generator and has trained the patient on how to safely control stimulation and to charge the system. 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. 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. 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. January 4, 2022 By Sean Whooley. 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. Multiple leads. 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.
MR safety: spinal cord stimulators - Questions and Answers in MRI If lithotripsy must be used, do not focus the energy near the IPG. 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. This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. See Full System Components below if the patient has an IPG and extensions implanted. 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. Consider seeking surgical advice if you cannot easily remove a lead. Lead movement. Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. 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. Generators contain batteries as well as other potentially hazardous materials. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. Up to two IPGs, leads, extensions, and burr hole covers may be implanted. Generator disposal. Make the Bold Choice High altitudes should not affect the neurostimulator; however, the patient should consider the movements involved in any planned activity and take precautions to avoid putting undue stress on the implanted system. 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. Neuromodulation. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Use extreme care when handling system components prior to implantation. 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. Device components. Do not use the system if the use-before date has expired. If lithotripsy must be used, do not focus the energy near the generator. 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. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. Instruct patients to use their neurostimulation system only after an authorized clinician has programmed the device and has trained the patient how to control stimulation and safely use the system. Neurostimulation should not be used on patients who are poor surgical candidates. 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. Removing a kinked sheath. 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. Ask patients with neurostimulators to shut off the device temporarily while the scan is performed. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. For this reason, programming at frequencies less than 30 Hz is not recommended. 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. An expiration date (or use-before date) is printed on the packaging. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. 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. Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation. For less than 30 m (100 ft) of water or pressures below 4.0 ATA, durations of less than 60 minutes are recommended. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Before diving or using a hyperbaric chamber, patients should contact their physician to discuss the effects of high pressure on their implanted system. Keep them dry to avoid damage. Do not handle the generator if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. Magnetic interference with consumer goods or electronic devices that contain magnets, such as mobile phones and smart watches, may unintentionally cause the neurostimulation system to turn on or turn off or affect communication between the device and generator; however, it will not change the prescribed programmed parameters. 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. The operation of the clinician programmer or patient controller could cause them to ignite, causing severe burns, injury, or death. 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). Exposure to body fluids or saline. 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. Single-use, sterile device. 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). Use caution when positioning the needle to avoid unintended injury to surrounding anatomical structures.
MRI Support | Abbott Expected effect from cessation of therapy, should disease symptoms return unexpectedly. Do not use excessive pressure when injecting through the sheath. Infections may require that the device be explanted. Do not crush, puncture, or burn the IPG because explosion or fire may result. When using a contralateral approach, advance the needle slowly into the epidural space and take caution as it enters. 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. Unlike other SCS systems, the Proclaim XR SCS system is recharge free. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. Wireless use restrictions. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Stylet handling. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. 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). Scanning under different conditions may cause device malfunction, severe patient injury, or death. Do not use short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. If needed, return the equipment to Abbott Medical for service. 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). Case damage. The system is intended to be used with leads and associated extensions that are compatible with the system.
Abbott - Spinal Cord Stimulation Have the patient check the device for proper functioning, even if the device was turned off. Component handling. Device modification. Lead insertion through sheath. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. *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.
Spinal Cord Stimulator Systems - Boston Scientific Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. 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 tip of the sheath may whip around and could cause harm to the patient. Additional risks to the patients, as a result of the placement and stimulation of the lead in the area of the dorsal root ganglion (DRG), include pain from setting the stimulation parameters too high. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. This equipment is not serviceable by the customer. 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. The device should be turned off and the doctor contacted if this occurs. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted. 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. 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 handling system components. 72750 MAT-2215018 v2.0 | Item approved for U.S. use only. Failure to do so may cause harm to the patient such as damage to the dura. If unpleasant sensations occur, the device should be turned off immediately using the patient magnet. Physicians should also consider underlying factors, such as previous neurological injury or prescribed medications (anticoagulants), that may predispose a patient to the risk of bleeding. Neurostimulation systems have materials that come in contact or may come in contact with tissue. For adverse effects observed in SCS clinical studies, refer to the clinical summaries manual for SCS systems. Abbott recently received new FDA-approved labeling which expands MRI compatibility with the leads used on the Proclaim TM XR Spinal Cord Stimulation System. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system. Device modification. This damage could result in loss of therapy, requiring additional surgery for system replacement. Select patients appropriately for deep brain stimulation. Implanting physicians should be experienced in stereotactic and functional neurosurgery. Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinsons disease. Clinician training. Removing components. 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 medical treatment. Transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). Poor surgical risks.
Instructions for Use Website - SJM Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. Read this section to gather important prescription and safety information. 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. Therefore, physicians should consider the following: Preoperatively, assess patients for the risks of depression and suicide. In rare cases, this can create a medical emergency.
Getting an MRI | Medtronic Package or component damage. Clinician training. Overcommunicating with the IPG.
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