Devices with one-hour recharge per day. Clinician programmers, patient controllers, and chargers are not waterproof. Use caution when positioning the needle to avoid unintended injury to surrounding anatomical structures. Ultrasonic scanning equipment. The following procedures are contraindicated for patients that have been implanted with this device: Diathermy therapy. 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. 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. Wireless use restrictions. Needle positioning. The system is intended to be used with leads and associated extensions that are compatible with the system. Do not crush, puncture, or burn these devices because explosion or fire may result. Nerve damage may result from traumatic or surgical nerve injury. Product materials. Insertion of a sheath without the lead may result in dural puncture. Infections may require that the device be explanted. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. Return any suspect components to Abbott Medical for evaluation. 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. Confirm the neurostimulation system is functioning. Scuba diving or hyperbaric chambers. The Eterna Spinal Cord Stimulation (SCS) System is designed to deliver low-intensity electrical impulses to nerve structures. Generators contain batteries as well as other potentially hazardous materials. Up to two IPGs, leads, extensions, and burr hole covers may be implanted. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Do not crush, puncture, or burn the IPG because explosion or fire may result. Do not bend, kink, or use surgical instruments on the stylet, as this may damage it. Lead movement. If needed, return the equipment to Abbott Medical for service. The IPG should be explanted before cremation because the IPG could explode. Return any suspect components to Abbott Medical for evaluation. The device should be turned off and the doctor contacted if this occurs. Scuba diving and hyperbaric chambers. January 4, 2022 By Sean Whooley. 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. 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. However, some patients may experience a decrease or increase in the perceived level of stimulation. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. 74373 MAT-2300644 v2.0 | Item approved for U.S. use only. commercial electrical equipment (such as arc welders and induction furnaces). Operation of machinery and equipment. Abbott Launches the World's Smallest Implantable, Rechargeable Spinal 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. Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Neurostimulation systems have materials that come in contact or may come in contact with tissue. 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. 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). If interference occurs, try holding the phone to the other ear or turning off the phone. Do not place TENS electrodes so that the TENS current passes over any part of the neurostimulation system. Before diving or using a hyperbaric chamber, patients should contact their physician to discuss the effects of high pressure on their implanted system. Detailed information on storage environment is provided in the appendix of this manual. 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. Proclaim XR SCS System Meaningful relief from chronic pain. Battery care. 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. Sterile components in this kit have been sterilized using ethylene oxide (EtO) gas before shipment and are supplied in sterile packaging to permit direct introduction into the sterile field. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training. away from the generator and avoid placing any smart device in a pocket near the generator. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. Confirm implant locations and scan requirements for the patients system. Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. Care and handling of components. Thorough psychiatric screening should be performed. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. Do not implant a device if the sterile package, the device, or any device components show signs of damage, tampering, or if the sterile seal is ruptured, or contamination is suspected for any reason. 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. 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. 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. 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. ), 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.). Return all explanted generators to Abbott Medical for safe disposal. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. Conscious sedation during removal. Sudden loss of stimulation may cause patients to fall or lose control of equipment or vehicles, injure others, or bring injury upon themselves. Electrocardiograms. If multiple leads or extensions are implanted, the leads and extensions should be routed in close proximity. Some of this systems electronic equipment, such as the programmer and controller, can radiate radiofrequency (RF) energy that may interfere with other electronic devices, including other active implanted devices. Mobile phones. Infection. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. High-output ultrasonics and lithotripsy. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system: Other active implanted devices. A risk of brain tissue damage exists with parameter settings using high amplitudes and wide pulse widths. For this reason, programming at frequencies less than 30 Hz is not recommended. Inserting the anchor. Damage to the system may not be immediately detectable. Transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). Introduction: Spinal cord stimulation is becoming an increasingly used modality for the treatment of chronic pain. The equipment is not serviceable by the customer. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Electrosurgery. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. High-output ultrasonics and lithotripsy. 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. 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. 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. Only apply software updates that are published directly by Abbott Medical. Set the electrosurgery device to the lowest possible energy setting. In rare cases, this can create a medical emergency. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). 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. Pregnancy and nursing. Component disposal. Minimize X-ray exposure to the implanted or externally worn electronic medical device by using the lowest possible X-ray tube current consistent with obtaining the required image quality and by making sure that the X-ray beam does not dwell over the device for more than a few seconds. 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. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. Abbott - Spinal Cord Stimulation If gas fumes or vapors catch fire, it could cause severe burns, injury, or death. If two systems are implanted, ensure that at least 20 cm (8 in.) Monitor the patients blood glucose levels in the perioperative period and instruct the patient to continue to monitor glucose levels as they may fluctuate as a response to surgery or to complications. To prevent injury or damage to the system, do not modify the equipment. 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. Remove leads slowly. This system is contraindicated for patients who meet the following criteria: The following procedures are contraindicated for patients with a deep brain stimulation system. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. 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 operation of the clinician programmer or patient controller could cause them to ignite, causing severe burns, injury, or death. Unlike other SCS systems, the ProclaimXR SCS system is recharge free. Other active implantable devices. Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient controller. Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient. If the operating field is bloody, wipe gloves, lead, stylet, and sheath before handling the lead. All components listed must be implanted unless noted as "optional." Patients should avoid activities that may put undue stress on the implanted components of the neurostimulation system. 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. Patients should cautiously approach such devices and should request help to bypass them. External defibrillation can cause induced currents in the leadextension portion of the neurostimulation system. 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. Component manipulation by patients. Mobile phones. Securing the lead with the lead stabilizer will mitigate this risk. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Security, antitheft, and radiofrequency identification (RFID) devices. 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. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. 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. After defibrillation, confirm the neurostimulation system is still working. 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. Complete any electrosurgery before connecting the leads or extensions to the neurostimulator. Application modification. 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. Needle insertion. Implant heating. Excessive lead migration may require reoperation to replace the leads. 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. 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. Advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan. 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. Always perform removal with the patient conscious and able to give feedback. Patients should not dive below 30 m (100 ft) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Patients will receive an identification card to carry with them that will inform emergency medical personnel of their implanted system. 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. Neuromodulation. It's small, discreet and available with Abbott's proprietary BurstDR stimulation, a new technology that's clinically proven to . Confirm that the neurostimulation system is functioning correctly during the implant procedure, before closing the neurostimulator pocket, and after the implant procedure. Less serious disadvantages of spinal cord stimulation devices include: Fluctuations in stimulation. 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. Remove the stylet from the lead only when satisfied with lead placement. Do not crush, puncture, or burn the IPG because explosion or fire may result. 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. Therapeutic magnets. 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. Exit Surgery mode during intraoperative testing and after the procedure is completed. This may occur once the lead is in place and is connected to the neurostimulator and activated. Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible. Pediatric use. If the lead extensions are routed in a loop, the loop will increase the potential for electromagnetic interference (EMI). These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. 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. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems (available online at medical.abbott/manuals). A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Lead insertion through sheath. Failure to push the short end of the soft tissue anchor into the ligament or fascia may result in lead migration and a procedure to revise the lead location. Component handling. Proclaim Plus Spinal Column Stimulation (SCS) System PRESCRIPTION AND SAFETY INFORMATION Read this section to gather important prescription and safety information. Use extreme care when handling system components prior to implantation. Package or component damage. Do not use the clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Store components and their packaging where they will not come in contact with liquids of any kind. Providing strain relief. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. The Prodigy MRI SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott's smallest implantable pulse generator (IPG). Patients with implanted Abbott leads should avoid scuba diving in more than 30 m (100 ft) of water or entering hyperbaric chambers above 4.0 atmospheres absolute (ATA) for any length of time, as this may damage the neurostimulation system. If the stylet is removed from the lead, it may be difficult to reinsert it. Recharge-by date. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. Spinal Cord Stimulator Systems - Boston Scientific Clinician training. Component manipulation. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. 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. Device modification. An expiration date (or use-before date) is printed on the packaging. If a patient experiences new or worsening depression or suicidal ideation, manage these symptoms appropriately. Follow proper infection control procedures. Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the management of disabling tremor. Removing each item in slow movements while holding the remaining components in place will assist this process. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. Postural changes. Ensure the patients neurostimulation system is in MRI mode. Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. separates the implanted IPGs to minimize unintended interaction with other system components.
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