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. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system: Other active implanted devices. 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. 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). 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. This neurostimulation system is contraindicated for patients who are. Pregnancy and nursing. Pain is not resolved. Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible. Return of symptoms and rebound effect. Securing the lead with the lead stabilizer will mitigate this risk. Control of the patient controller. Scuba diving or hyperbaric chambers. The safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. 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. 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. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. 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. The Eterna Spinal Cord Stimulation (SCS) System is designed to deliver low-intensity electrical impulses to nerve structures. Patients should cautiously approach such devices and should request help to bypass them. For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. Component disposal. If such exposure occurs, clean the affected parts with sterile, deionized water or sterile water for irrigation, and dry them completely prior to lead connection and implantation. Patients should be advised to avoid carrying mobile phones in their shirt pocket or otherwise placing them directly over the deep brain stimulation system components. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. 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). Do not over-manipulate the sheath and lead system as this may result in trauma within the epidural space. 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. Additionally, all patients will be awake and conversant during the procedure to minimize the impact. New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. Ensure the patients neurostimulation system is in MRI mode. 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. Excessive lead migration may require reoperation to replace the leads. 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. 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. Approved models and implant locations for an MR Conditional lead-only system. 74373 MAT-2300644 v2.0 | Item approved for U.S. use only. 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. Keep dry to avoid damage. The system is intended to be used with leads and associated extensions that are compatible with the system. INDICATIONS FOR USE If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Especially consider the following additional factors when selecting patients: Level of available support from a caregiver. Perception of higher levels of stimulation has been described by some patients as uncomfortable, painful, or jolting. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. Damage to the system may not be immediately detectable. Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the neurostimulation system. Scuba diving and hyperbaric chambers. Avoid placing equipment components directly over other electronic devices. Patients should avoid charging their generator over an incision that has not completely healed. To prevent injury or damage to the system, do not modify the equipment. Nerve damage may result from traumatic or surgical nerve injury. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. The operation of these devices could cause them to ignite, causing severe burns, injury, or death. If the implanted system contains components or models not listed in the followingtable, then the system is considered MR Unsafe. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. 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. Lead inspection. Recharge-by date. These activities include but are not limited to climbing ladders and operating potentially dangerous machinery, power tools, and vehicles. Implanting physicians should be experienced in stereotactic and functional neurosurgery. The long-term safety associated with multiple implants, leads left in place without use, replacement of leads, multiple implants into the target structure, and lead explant is unknown. Clinician training. 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. Transcutaneous electrical nerve stimulation (TENS). Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura. If lithotripsy must be used, do not focus the energy near the IPG. Use extreme care when using sharp instruments or electrosurgery devices around the lead to avoid damaging the lead. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control. Implantation of multiple leads. Advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan. 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. Do not use excessive pressure when injecting through the sheath. Scuba diving or hyperbaric chambers. Patient activities and environmental precautions. Safety Topic / Subject Spinal Cord Stimulation (SCS) Systems, Abbott and St. Jude Medical. Our Invisible Trial System TM is a discreet, app . Explosive and flammable gasses. Battery care. To prevent unintended stimulation, do not modify the generator software in any way. Advise patients about adverse effects. 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). IPG placement. In the case that a medical treatment is administered where an electrical current is passed through the body from an external source, first deactivate the IPG by setting all electrodes to off, turning stimulation off, and setting amplitude to zero. 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. Charge density can be reduced by lowering the stimulation amplitude or pulse width. Return any suspect components to Abbott Medical for evaluation. The system can be programmed to use parameter settings outside the range of those used in the clinical studies. External defibrillation can cause induced currents in the lead-extension portion of the neurostimulation system. 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. The website that you have requested also may not be optimized for your screen size. Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. 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. Sources of therapeutic radiation include therapeutic X-rays, cobalt machines, and linear accelerators. 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. In addition, a component must be implanted in its approved location as listed in the following table or the entire implanted system is considered MRUnsafe. External defibrillators. Infections related to system implantation might require that the device be explanted. Electrosurgery. 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. Implanting physicians or anesthesiologists should consult practice guidelines for the intraoperative management of patients with diabetes. Using the tunneling tool. 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. Return them to Abbott Medical for proper disposal. 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. If two systems are implanted, ensure that at least 20 cm (8 in.) Securing the anchor. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Wireless use restrictions. Complete any electrosurgery before connecting the leads or extensions to the neurostimulator. Conversely, the other active implanted device may interfere with the operation of the neurostimulation system. Battery precaution. Select patients appropriately for deep brain stimulation. Proclaim Plus Spinal Column Stimulation (SCS) System PRESCRIPTION AND SAFETY INFORMATION Read this section to gather important prescription and safety information. Before beginning a CT scan, the operator should use CT scout views to determine if implanted or externally worn electronic medical devices are present and if so, their location relative to the programmed scan range. Lead handling. **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. PATIENTS 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. Changes in blood glucose levels in response to any adverse effect
Magnetic resonance imaging (MRI). Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Follow proper infection control procedures. Security, antitheft, and radiofrequency identification (RFID) devices. 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. Expected effect from cessation of therapy, should disease symptoms return unexpectedly. Advancing components. Sudden loss of stimulation may cause patients to fall or lose control of equipment or vehicles, injure others, or bring injury upon themselves. Mobile phones. Infection. Patients will receive an identification card to carry with them that will inform emergency medical personnel of their implanted system. 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. 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. 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 information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems. If the sheath has been kinked during delivery, slowly retract through the needle with the curve facing the same direction as the bevel. Device modification. 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. Store components and their packaging where they will not come in contact with liquids of any kind. Keep them dry to avoid damage. This system is contraindicated for patients who meet the following criteria: The following procedures are contraindicated for patients with a deep brain stimulation system. Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment. Operating the device near gas fumes or vapors could cause them to catch fire. Consider seeking surgical advice if you cannot easily remove a lead. Use extreme care when handling system components prior to implantation. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. Keep them dry to avoid damage. 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. 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. Therapeutic radiation. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. Explosive and flammable gasses. If lithotripsy must be used, do not focus the energy near the IPG. 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 specific indications, contraindications, instructions, warnings, precautions, and adverse effects about system components available in your country or region, see the approved clinician's manual for those components. Patients should avoid activities that may put undue stress on the implanted components of the neurostimulation system. Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinsons disease. 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. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. Ask patients with neurostimulators to shut off the device temporarily while the scan is performed. Always be aware of the needle tip position. Patients who failed to receive effective pain relief during trial stimulation are contraindicated to process to the permanent implant procedure. If they must go through or near a gate or doorway containing this type of device, patients should move quickly and then check their IPG to determine if it is turned on or off. Advise patients to use their patient controller to communicate with their IPG only when needed because excessive communication with the IPG can shorten the remaining battery life. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. After defibrillation, confirm the neurostimulation system is still working. Return all explanted components to Abbott Medical for safe disposal. It is extremely important to select patients appropriately for neurostimulation. Ensure the neurostimulator is off before initiating an electrocardiogram (ECG). Falling and other traumatic accidents can damage shallowly implanted components such as the leads and extensions. 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). Removing components. Computed tomography (CT). Object Category Spinal Cord Stimulation Systems: St. Jude Medical. Jude, Medtronic).Most of the early models of these devices were considered MR Unsafe primarily due to the theoretical risk of spinal cord injury from heating of the the electrode tip by RF-induced currents (the so-called antenna effect). Read this section to gather important prescription and safety information. 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. Lead insertion through sheath. Caution patients to not make unauthorized changes to physician-established stimulation parameters. If the sheath is not responding to rotation, do not rotate the steering wing out of plane from the curve of the sheath more than 90 degrees. 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. The abrupt cessation of stimulation for any reason will probably cause disease symptoms to return. Stimulation effectiveness has been established for one year. 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. ), 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.). Clinician programmers, patient controllers, and chargers are not waterproof. Failure to do so may cause harm to the patient such as damage to the dura. 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. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. 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. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. Needle positioning. Infections may require that the device be explanted. Application modification. Batteries can explode, leak, or melt if disassembled, shorted (when battery connections contact metal), or exposed to high temperature or fire. Low frequencies. If radiation therapy is required, the area over the implanted generator should be shielded with lead. Neurostimulation systems have materials that come in contact or may come in contact with tissue. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. 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. Use caution when positioning the needle to avoid unintended injury to surrounding anatomical structures. 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. radiofrequency identification (RFID) devices. Do not use excessive force to push the lead or sheath into the neural foramen as this may result in permanent or transient nerve damage. Diathermy is further prohibited because it may also damage the neurostimulation system components. Patient selection. Sheath retraction. Infections related to system implantation might require that the device be explanted. Placing the IPG. Unwanted changes in stimulation may include a jolting or shocking feeling. 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. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. 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.
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