Confirm implant locations and scan requirements for the patients system. Return any suspect components to Abbott Medical for evaluation. Infections related to system implantation might require that the device be explanted. Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target. Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. Implanting physicians should be experienced in stereotactic and functional neurosurgery. Neuromodulation. Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Return any suspect components to Abbott Medical for evaluation. 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. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. radiofrequency identification (RFID) devices. To prevent injury or damage to the system, do not modify the equipment. If two systems are implanted, ensure that at least 20 cm (8 in.) 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. Use extreme care when handling system components prior to implantation. *Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least two prior pharmacologic treatments from at least two different drug classes and continued their pharmacologic therapy during the clinical study. If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals. Abbott (NYSE:ABT) announced today that it received FDA approval for new magnetic resonance imaging (MRI) compatibility for the Proclaim system. Do not use a clinician programmer or patient controller around explosive or flammable gas fumes or vapors. Explosive or flammable gasses. 2013;16(5):471-482. The operation of these devices could cause them to ignite, causing severe burns, injury, or death. The system is intended to be used with leads and associated extensions that are compatible with the system. 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. Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinsons disease. 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. Patient's physical ability, as patients with higher degrees of motor impairment might have difficulty with the physical requirements of monitoring the device. Diathermy is further prohibited because it may also damage the neurostimulation system components. Do not handle the generator if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. Suicidal ideation, suicide attempts, and suicide are events that have also been reported. Note: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. Patients should exercise reasonable caution when bathing. Removing components. Our Invisible Trial System TM is a discreet, app . Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. IPG placement. 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. If lithotripsy must be used, do not focus the energy near the IPG. Ensure the patients neurostimulation system is in MRI mode. Operation of machines, equipment, and vehicles. Using surgical instruments. Do not place TENS electrodes so that the TENS current passes over any part of the neurostimulation system. Infection. 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. Thorough psychiatric screening should be performed. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or render the patient incapable of controlling the generator. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. Confirm that the neurostimulation system is functioning correctly during the implant procedure, before closing the neurostimulator pocket, and after the implant procedure. 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. To find Shipping Material Packaging Waste information, select Healthcare Professionals. Devices with one-hour recharge per day. Implantation at vertebral levels above T10. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. High stimulation outputs. Abbott recently received new FDA-approved labeling which expands MRI compatibility with the leads used on the Proclaim TM XR Spinal Cord Stimulation System. Consumer goods and electronic devices. Needle insertion. Patient selection. Carefully inspect the lead (in the sterile field) for damage after removing it from the sterile package. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. Guidance and conditions for MRI safety with neuromodulation systems, neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html, Upper buttock, low back, midline, flank or abdomen, Upper buttock, low back, flank, or abdomen, 6170 directional lead, 30 cm, 0.5-mm spacing, black, Fully implanted in the brain, routed under the scalp, 6010 Guardian cranial burr hole cover system, Fully implanted in the brain, routed under the scalp and connected to an extension, Head and neck, routed to the IPG on the same side of the body as the IPG, Lead-only systems, which consist of at least one implanted lead connected to a lead protection boot, as well as an optional cranial burr hole cover, Full systems, which consist of at least one implantable pulse generator (IPG), lead and extension, as well as an optional cranial burr hole cover. To correct the effects of typical interference, keep wireless communication equipment at least 15 cm (6 in) from the IPG. Interference with other 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. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Removing each item in slow movements while holding the remaining components in place will assist this process. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. Stimulation effectiveness has been established for one year. Patient training. Implantation of two systems. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. If lithotripsy must be used, do not focus the energy near the generator. Return all explanted generators to Abbott Medical for safe disposal. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Household appliances. Proclaim Plus Spinal Column Stimulation (SCS) System PRESCRIPTION AND SAFETY INFORMATION Read this section to gather important prescription and safety information. Conscious sedation. Damage to the system may not be immediately detectable. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Recharge-by date. Device modification. 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. Advance the needle and guidewire slowly. ** commercial electrical equipment (such as arc welders and induction furnaces). INTENDED USE This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Spinal cord stimulation of the dorsal root ganglion for groin pain-a retrospective review. Do not resterilize or reimplant an explanted system for any reason. 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. Exit Surgery mode during intraoperative testing and after the procedure is completed. Physicians should also discuss any risks of MRI with patients. 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. 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. Batteries can explode, leak, or melt if disassembled, shorted (when battery connections contact metal), or exposed to high temperature or fire. 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. Scuba diving and hyperbaric chambers. Do not bend, kink, or stretch the lead body, sheaths, or other components as this may result in damage to the component and poor function. Infections may require that the device be explanted. 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. Package or component damage. Object Category Spinal Cord Stimulation Systems: St. Jude Medical. Interference with wireless equipment. Cremation. Advise patients to not use their device when engaging in activities that might cause it to get wet, such as swimming or bathing. Implantation of two systems. Confirm the neurostimulation system is functioning correctly after the procedure. Lasting Relief through our smallest system yet. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott. Component disposal. Generators contain batteries as well as other potentially hazardous materials. 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. External defibrillators. Pain is not resolved. Implantation of this neurostimulation system is contraindicated for the following: Patients for whom test stimulation is unsuccessful. Pregnancy and nursing. Consider seeking surgical advice if you cannot easily remove a lead. To prevent unintended stimulation, do not modify the operating system in any way. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted. Patient activities and environmental precautions. 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 interference occurs, try holding the phone to the other ear or turning off the phone. maximize the distance between the implanted systems; Use in patients with diabetes. The needle will be inserted at a steeper angle than in an antegrade approach and there is a greater chance of dural puncture that will lead to a cerebrospinal fluid leak. The Eterna Spinal Cord Stimulation (SCS) System is designed to deliver low-intensity electrical impulses to nerve structures. Implant heating. Implantation of multiple leads. After any surgery, check the neurostimulation system for the following: Check the neurostimulator to ensure Surgery mode has been turned off, even if Surgery mode was not turned on at the beginning or during the procedure. High-output ultrasonics and lithotripsy. Therapeutic radiation. The tip of the sheath may whip around and could cause harm to the patient. 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. 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.). This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Return the explanted IPG to Abbott Medical. 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. Exposure of the metal contacts, such as those on the connection end of a lead or extension, to body fluids or saline prior to connection can lead to corrosion. High stimulation outputs and charge density limits. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Do not use the clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Patients should not dive below 30 m (100 ft) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). The Prodigy MRI SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott's smallest implantable pulse generator (IPG). If the lead extensions are routed in a loop, the loop will increase the potential for electromagnetic interference (EMI). away from the generator and avoid placing any smart device in a pocket near the generator. IPG 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. Before your patient undergoes an MRI scan: Confirm the MR Conditional components and location of the system. Placement of lead connection in neck. Providing strain relief. Care and handling of components. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. 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. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Maximize the distance between the implanted systems (minimum separation distance of approximately 8 cm (3 in.) Patients should cautiously approach such devices and should request help to bypass them. If this date has been reached or has been exceeded before the date of implantation, the generator should be charged prior to implantation. Additional Disadvantages. High-output ultrasonics and lithotripsy. Use extreme care when handling system components. Neurostimulation should not be used on patients who are poor surgical candidates. 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. Advise your patient to avoid manipulating the implanted system components (e.g., the neurostimulator, the burr hole site). Wireless use restrictions. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. IPGs contain batteries as well as other potentially hazardous materials. Physicians should also discuss any risks of MRI with patients. For complete and comprehensive MRI support, parameters, and precautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. Sheath insertion precaution. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. 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. Clinician programmers, patient controllers, and chargers are not waterproof. Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation. separates the implanted IPGs to minimize unintended interaction with other system components. The website that you have requested also may not be optimized for your screen size. If the stylet is removed from the lead, it may be difficult to reinsert it. Do not crush, puncture, or burn the IPG because explosion or fire may result. Stimulation effectiveness. Stimulation Modes. 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), radiofrequency identification (RFID) devices, some medical procedures (such as therapeutic radiation, static magnetic field [SMF] therapy, and electromagnetic lithotripsy), and some medical devices (such as bone growth stimulators, transcutaneous electrical nerve stimulation [TENS] devices, dental drills, and ultrasonic probes). Instruct patients to designate a representative (family member or close friend) to notify any emergency medical personnel of their implanted neurostimulation system if emergency care is required. 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. For this reason, programming at frequencies less than 30 Hz is not recommended. Do not use excessive pressure when injecting through the sheath. Select patients appropriately for deep brain stimulation. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. Patients without an MR Conditional neurostimulation system should not be subjected to MRI because the electromagnetic field generated by an MRI may damage the device electronics and induce voltage through the lead that could jolt or shock the patient. Wireless use restrictions. 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. We offer products that are MR Conditional for spinal cord stimulation (SCS) and dorsal root ganglion (DRG) therapy. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. 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. Mobile phones. The force of the instruments may damage the lead or stylet. 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.
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