** To prevent unintended stimulation, do not modify the generator software in any way. Sheath retraction. Avoid excessive stimulation. Return all explanted IPGs to Abbott Medical for safe disposal. INTENDED USE This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. PDF View Shellock R & D Services, Inc. email: . Physicians should also discuss any risks of MRI with patients. separates the implanted generators to minimize unintended interaction with other system components. Caution patients to not make unauthorized changes to physician-established stimulation parameters. Consider seeking surgical advice if you cannot easily remove a lead. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. For adverse effects observed in SCS clinical studies, refer to the clinical summaries manual for SCS systems. For complete and comprehensive MRI support, parameters, and precautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. 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). After defibrillation, confirm the neurostimulation system is still working. 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. Stimulation in unwanted places (such as radicular stimulation of the chest wall), Lead migration, causing changes in stimulation or reduced pain relief, Epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement of a lead in the epidural space, Paralysis, weakness, clumsiness, numbness, or pain below the level of the implant, Persistent pain at the electrode or generator site, Seroma (mass or swelling) at the generator site, Allergic or rejection response to implant materials, Implant migration or skin erosion around the implant. Explosive or flammable gasses. Patient selection. Failure to do so may result in difficulty delivering the lead. Patients should cautiously approach such devices and should request help to bypass them. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. 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. Use caution when securing the soft tissue anchor because damage to the anchor or lead can occur and result in failure of the system. This may occur once the lead is in place and is connected to the neurostimulator and activated. Charge density can be reduced by lowering the stimulation amplitude or pulse width. Electrosurgery. Proclaim XR Spinal Cord Stimulation (SCS) System, Model 3660 and Model 3662 . Surgical complications include, but are not limited to, the following: intracranial hemorrhage (which can lead to stroke, paralysis, or death); cerebrospinal fluid leakage or cerebrospinal fluid abnormality; persistent pain at surgery site or IPG site; brachial plexus injury (nerves to chest, shoulder and arm); postoperative pain, stress, or discomfort; hemiparesis (muscular weakness or partial paralysis on one side of body); ballism or hemiballism (uncontrollable movements on both or only one side of the body); confusiontransient, nocturnal or ongoing; cognitive impairment, including delirium, dementia, disorientation, psychosis and speech difficulties; pulmonary embolism (sudden blood vessel obstruction); aborted procedures (air embolism, unable to find target, surgical complication, etc. Multiple leads. commercial electrical equipment (such as arc welders and induction furnaces). Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. ); complications from unusual physiological variations in patients, including foreign body rejection phenomena; paralysis (loss of motor function, inability to move); Possible deep brain stimulation complications. 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. Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. Patients should exercise reasonable caution when bathing. Stabilizing the lead during insertion. In rare cases, this can create a medical emergency. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Follow proper infection control procedures. If the operating field is bloody, wipe gloves, lead, stylet, and sheath before handling the lead. Anchoring leads. Generator disposal. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. 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. 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 . Removing each item in slow movements while holding the remaining components in place will assist this process. This equipment is not serviceable by the customer. PATIENTS If a system does not meet the MR Conditional requirements, consider it MR Unsafe. 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. The Eterna Spinal Cord Stimulation (SCS) System is designed to deliver low-intensity electrical impulses to nerve structures. It is extremely important to select patients appropriately for neurostimulation. The following warnings apply to this neurostimulation system. 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. When multiple leads are implanted, route the lead extensions so the area between them is minimized. separates the implanted IPGs to minimize unintended interaction with other system components. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief. Pain is not resolved. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. Read this section to gather important prescription and safety information. Skydiving, skiing, or hiking in the mountains. High-output ultrasonics and lithotripsy. Place the neurostimulator in Surgery mode before using an electrosurgery device. Package or component damage. 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. IPGs contain batteries as well as other potentially hazardous materials. Exit Surgery mode during intraoperative testing and after the procedure is completed. Exposure to body fluids or saline. 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. 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. Confirm the neurostimulation system is functioning. Emergency procedures. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia). Sheath insertion warning. If lithotripsy must be used, do not focus the energy near the IPG. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Do not use excessive pressure when injecting through the sheath. Securing the lead with the lead stabilizer will mitigate this risk. 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. Application modification. 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. Output power below 80 W is recommended for all activations. Device modification. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. To prevent unintended stimulation, do not modify the operating system in any way. Care and handling of components. Pediatric use. Changes in blood glucose levels in response to any adverse effect The BurstDR stimulation mode has not been evaluated for effectiveness in the diabetic peripheral neuropathy (DPN) population. High stimulation outputs. This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.). Instruct patients to contact their physician if they experience any adverse effects, such as unusual pain or discomfort during stimulation and swelling, redness, tenderness, or pain around implanted components. 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. If radiation therapy is required, the area over the implanted generator should be shielded with lead. Free from the hassles of recharging. If gas fumes or vapors catch fire, it could cause severe burns, injury, or death. 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. 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. 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. away from the generator and avoid placing any smart device in a pocket near the generator. Pediatric use. The abrupt cessation of stimulation for any reason will probably cause disease symptoms to return. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for six to eight weeks after implantation of a neurostimulation system. Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the management of disabling tremor. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. Patients will receive an identification card to carry with them that will inform emergency medical personnel of their implanted system. 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. Only apply software updates that are published directly by Abbott Medical. Security, antitheft, and radiofrequency identification (RFID) devices. ), 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.). External defibrillators. 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. For less than 30 m (100 ft) of water or pressures below 4.0 ATA, durations of less than 60 minutes are recommended. 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. Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards. 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. Keep them dry to avoid damage. Keep the device dry. Do not use the application if the operating system is compromised (that is, jailbroken). Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. 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. 74372 MAT-2215216 v3.0 | Item approved for U.S. use only. 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. 71376 MAT-2006974 v2.0 | Item approved for U.S. use only. Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the neurostimulation system. 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.**. 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. 72184 MAT-2214513 v1.0 | Item approved for U.S. use only. Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. 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. High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. Make the Bold Choice 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. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Postural changes. Use extreme care when handling system components prior to implantation. If lithotripsy must be used, do not focus the energy near the generator. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Scuba diving or hyperbaric chambers. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. Generators contain batteries as well as other potentially hazardous materials. **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. 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. 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. Implantation of multiple leads. Infection. Return of symptoms and rebound effect. Patients should cautiously approach such devices and should request help to bypass them. Interference with other devices. Therapeutic radiation may damage the electronic circuitry of an implanted neurostimulation system, although no testing has been done and no definite information on radiation effects is available. If unpleasant sensations occur, turn off stimulation immediately. Patients should avoid activities that may put undue stress on the implanted components of the neurostimulation system. Abbott's neurostimulation therapies are designed to alter those signals as they travel to the brain, and minimize how you perceive pain.3 PROVEN SAFE AND EFFECTIVEWITH BENEFITS BEYOND PAIN RELIEF2, 4 One of the advantages of neurostimulation is that you can try the therapy using a temporary system before committing to an implanted system. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. Removing a kinked sheath. Mobile phones. Failure to do so may result in damage to the sheath. 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. Unwanted changes in stimulation may include a jolting or shocking feeling. 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. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. If needed, return the equipment to Abbott Medical for service. Mobile phones. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. Component manipulation. Device modification. 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). Surgeon training. The safety and efficacy of the implantation of greater than four leads have not been evaluated. Radiofrequency or microwave ablation. 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. radiofrequency identification (RFID) devices. Implantation at vertebral levels above T10. Securing the IPG. The effect of other implanted devices, including deep brain stimulators, peripheral nerve stimulators, implanted drug delivery pumps, and cochlear implants on the neurostimulation system are unknown. Neurostimulation should not be used for patients with comorbidities that could prevent successful implant or effective therapy. Control of the patient controller. When using a contralateral approach, advance the needle slowly into the epidural space and take caution as it enters. Always perform removal with the patient conscious and able to give feedback. Implantation of two systems. 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. Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system. The Prodigy MRI SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott's smallest implantable pulse generator (IPG). Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. 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. Return all explanted components to Abbott Medical for safe disposal. Follow proper infection control procedures. Do not use the system if the use-before date has expired. 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. 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). Advise patients to inform their healthcare professional that they should not be exposed to diathermy treatment. Lead movement. Poor surgical risks. 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. Patients should also avoid any activities that would be potentially unsafe if their symptoms were to return unexpectedly. Electromagnetic interference (EMI). Infections related to system implantation might require that the device be explanted. Nonadjacent leads and extensions have the possibility of creating a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Schu S, Gulve A, ElDabe S, et al. If the lead is unable to deploy out of the sheath, inject sterile water or saline slowly to release tissue that may have entered between the sheath and the lead. Conversely, the other active implanted device may interfere with the operation of the neurostimulation system. Use appropriate sterile technique when implanting leads and the IPG. Perception of higher levels of stimulation has been described by some patients as uncomfortable, painful, or jolting. 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. If unpleasant sensations occur, the device should be turned off immediately. (2) The method of its application or use. All components listed must be implanted unless noted as "optional." If this date has been reached or has been exceeded before the date of implantation, the generator should be charged prior to implantation. Interference with wireless equipment. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. 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. 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. Neurosurgery Pain Management Orthopaedic Surgery Do not use the application if the operating system is compromised (i.e., jailbroken). Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. Implantation of this neurostimulation system is contraindicated for the following: Patients for whom test stimulation is unsuccessful. Unlike other SCS systems, the ProclaimXR SCS system is recharge free. Educate patients and caregivers about these potential risks prior to implantation, and be sure that they know about the importance of ongoing support and follow-up, including when to contact their health care provider. 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. 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. Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient. Operation of machines, equipment, and vehicles. 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). Electrosurgery. 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. 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. 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. 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. Component fracture or dislodgement may result in loss of stimulation, intermittent stimulation, stimulation at the fracture site, and additional surgery to replace or reposition the component. Conditional 5. 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. 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. However, current data shows that most patients using BurstDR stimulation therapy do not experience paresthesia. Long-term safety and effectiveness. Follow proper infection control procedures. External defibrillators. Neurostimulation should not be used on patients who are poor surgical candidates. The Proclaim XR SCS system can provide relief to . The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. After defibrillation, confirm the neurostimulation system is still working. NOTE: During intraoperative testing, Surgery mode must be turned off for the neurostimulation system to function correctly. Do not place the IPG deeper than 4.0 cm (1.57 in) because the clinician programmer or patient controller may not communicate effectively with the IPG. Battery precaution. If two systems are implanted, ensure that at least 20 cm (8 in.) Store components and their packaging where they will not come in contact with liquids of any kind. 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.
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