Our Invisible Trial System TM is a discreet, app . During the 2000s about a dozen companies sold and manufactured SCS systems worldwide, including the "big three" (Boston Scientific, Abbott/St. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. External defibrillation can cause induced currents in the leadextension portion of the neurostimulation system. Care and handling of components. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. Diathermy is further prohibited because it may also damage the neurostimulation system components. Avoid excessive stimulation. Inserting 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. Return all explanted components to Abbott Medical for safe disposal. Before reinserting the sheath, verify there is no damage to the sheath. Follow proper infection control procedures. Damage to the system may not be immediately detectable. 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. Wireless use restrictions. 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 implanted components of this neurostimulation system are intended for a single use only. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. This may occur once the lead is in place and is connected to the neurostimulator and activated. Advance the needle and guidewire slowly. Patients should avoid activities that may put undue stress on the implanted components of the neurostimulation system. Safety Topic / Subject Spinal Cord Stimulation (SCS) Systems, Abbott and St. Jude Medical. Safety and effectiveness has not been established for patients with a neurological disease other than Parkinsons disease or essential tremor, previous surgical ablation procedures, dementia, coagulopathies, or moderate to severe depression; patients under 22 years; implantation in targets other than the STN for Parkinson's disease and the VIM for essential tremor; patients with an active implantable device; patients requiring MRI. For complete MRI guidance, parameters and cautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. Select patients appropriately for deep brain stimulation. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. The use of high-output devices, such as an electrohydraulic lithotriptor, may damage the electronic circuitry of an implanted generator. 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. Do not use surgical instruments to handle 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. 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. 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 advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Neurostimulation should not be used on patients who are poor surgical candidates. Perception of higher levels of stimulation has been described by some patients as uncomfortable, painful, or jolting. Nonadjacent leads and extensions have the possibility of creating a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. To prevent injury or damage to the system, do not modify the equipment. 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.**. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) The Prodigy MRI SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott's smallest implantable pulse generator (IPG). The safety and efficacy of the implantation of greater than four leads have not been evaluated. This includes oxygen-enriched environments such as hyperbaric chambers. Do not use the application if the operating system is compromised (that is, jailbroken). INDICATIONS FOR USE Pediatric use. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. 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. Wireless use restrictions. This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. away from the generator and avoid placing any smart device in a pocket near the generator. External defibrillators. Poor surgical risks. The Proclaim TM SCS System is also the first upgradeable and recharge-free spinal cord stimulation system capable of delivering both tonic stimulation and Abbott's proprietary BurstDR stimulation waveform, a superior therapy designed to more closely mimic how pain signals travel to the brain. Confirm that no adverse conditions to MR scanning are present. IPG disposal. For more information about MR Conditional deep brain stimulation (DBS) components and systems, including equipment settings, scanning procedures, and a complete listing of conditionally approved components, refer to the MRI procedures clinician's manual for DBS systems(available online atmedical.abbott/manuals). 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. For complete and comprehensive MRI support, parameters, and precautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. Implantation of two systems. Ensure the patients neurostimulation system is in MRI mode. Return all explanted components to Abbott Medical for safe disposal. High stimulation outputs and charge density limits. 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. 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. 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. Keep them dry to avoid damage. 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. Implantation of two systems. Needle positioning. Scuba diving and hyperbaric chambers. Device modification. Do not use the clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Patients should cautiously approach such devices and should request help to bypass them. We offer products that are MR Conditional for spinal cord stimulation (SCS) and dorsal root ganglion (DRG) therapy. To prevent injury or damage to the system, do not modify the equipment. 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. For complete guidance, directions, and cautions on MRI safety with a specific device,please review the MRI procedure clinician's manual. Return of symptoms and rebound effect. 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. Removing each item in slow movements while holding the remaining components in place will assist this process. All components listed must be implanted unless noted as "optional." 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. Back pain. Do not use the system if the use-before date has expired. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system. Implantation at vertebral levels above T10. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. separates the implanted IPGs to minimize unintended interaction with other system components. Detailed information on storage environment is provided in the appendix of this manual. Implanting physicians or anesthesiologists should consult practice guidelines for the intraoperative management of patients with diabetes. six to eight weeks after implantation of a neurostimulation system. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Emergency procedures. If use of electrocautery is necessary, place the neurostimulator in Surgery mode using the clinician programmer app or the patient controller app before using an electrosurgery device. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems. 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. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for at least six weeks after implantation. commercial electrical equipment (such as arc welders and induction furnaces). 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. Therapeutic radiation. Use caution when sedating the patient. INTENDED USE This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. High-output ultrasonics and lithotripsy. Implanting physicians should be experienced in stereotactic and functional neurosurgery. Clinician training. Keep them dry to avoid damage. Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient. External defibrillation can cause induced currents in the lead-extension portion of the neurostimulation system. Introduction: Spinal cord stimulation is becoming an increasingly used modality for the treatment of chronic pain. Pregnancy and nursing. Failure to do so may cause harm to the patient such as damage to the dura. Sheath insertion warning. 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. Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. Diathermy therapy. Advancing components. Pressures below 30 m (100 ft.) of water (or above 4.0 ATA) could damage the neurostimulation system. If the sheath has been kinked during delivery, slowly retract through the needle with the curve facing the same direction as the bevel. Patient's age, as very young or very old patients may have difficulty performing required monitoring of the device. Insertion of a sheath without the lead may result in dural puncture. Consumer goods and electronic devices. Do not crush, puncture, or burn the IPG because explosion or fire may result. Damage to shallow implants. Sheath retraction. Postural changes. maximize the distance between the implanted systems; Use in patients with diabetes. 2013;16(5):471-482. Patients should not dive below 30 m (100 ft.) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment. If the lead extensions are routed in a loop, the loop will increase the potential for electromagnetic interference (EMI). 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. Lead handling. Infections related to system implantation might require that the device be explanted. Magnetic resonance imaging (MRI). 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. 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. These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. The IPG should be placed into the pocket, at a depth not to exceed 4.0 cm (1.57 in), with the logo side facing toward the skin surface. The system is intended to be used with leads and associated extensions that are compatible with the system. Stimulation Modes. 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.). Skydiving, skiing, or hiking in the mountains. ** Safety has not been established for TMS or ECT in patients who have an implanted neurostimulation system. Patients who failed to receive effective pain relief during trial stimulation are contraindicated to process to the permanent implant procedure. Explosive and flammable gasses. 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. Use extreme care when using sharp instruments or electrosurgery devices around the lead to avoid damaging the lead. Mobile phones. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. Do not resterilize or reimplant an explanted system for any reason. 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. 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. and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). Electrosurgery. Ultrasonic scanning equipment. Exposure to body fluids or saline. Approved models and implant locations for an MR Conditional lead-only system. Carefully inspect the lead (in the sterile field) for damage after removing it from the sterile package. The following warnings apply to this neurostimulation system. 74372 MAT-2215216 v3.0 | Item approved for U.S. use only. Set the electrosurgery device to the lowest possible energy setting. Mobile phones. 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. High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. Infections may require that the device be explanted. 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. The effect of mobile phones on deep brain stimulation is unknown. Failure to do so may result in damage to the sheath. However, some patients may experience a decrease or increase in the perceived level of stimulation. Do not bring the suture needle in contact with an IPG, lead, or extension, or the component may be damaged. 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. 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). 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. Lasting Relief through our smallest system yet. FDA's expanded . If radiation therapy is required, the area over the implanted IPG should be shielded with lead. If lithotripsy must be used, do not focus the energy near the generator. Return them to Abbott Medical for proper disposal. Exposure to body fluids or saline. Explosive and flammable gasses. Sources of therapeutic radiation include therapeutic X-rays, cobalt machines, and linear accelerators. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Lead inspection. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. 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 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. Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the neurostimulation system. Application modification. Securing the anchor. Before diving or using a hyperbaric chamber, patients should contact their physician to discuss the effects of high pressure on their implanted system. This equipment is not serviceable by the customer. Return any suspect components to Abbott Medical for evaluation. Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. 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. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Always perform removal of implanted components with the patient conscious and able to give feedback. Electromagnetic interference (EMI). Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target. Set the electrosurgery device to the lowest possible energy setting. In some cases, symptoms may return with a greater intensity than what a patient experienced before system implantation (rebound effect). If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Infection. Infection. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. 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. Do not crush, puncture, or burn the generator because explosion or fire may result. If the patient requires a CT scan, all stimulation should be turned off before the procedure. For less than 30 m (100 ft) of water or pressures below 4.0 ATA, durations of less than 60 minutes are recommended. Follow proper infection control procedures. 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. Loss of coordination is a potential side effect of DBS therapy. Handle the device with care. A multicenter, prospective trial to assess the safety and performance of the spinal modulation dorsal root ganglion neurostimulator system in the treatment of chronic pain. 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. 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. 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. 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. 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 . Placing the IPG. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. High stimulation outputs. For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual. The neurostimulator is controlled by a trained operator and the starting point for the stimulation will be set to the lowest available settings. Battery care. Do not crush, puncture, or burn these devices because explosion or fire may result. Advise patients who experience these types of stimulation changes to turn down the amplitude or turn off the IPG before making extreme posture changes or abrupt movements such as stretching, lifting their arms over their heads, or exercising.
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