Follow proper infection control procedures. Sheath insertion precaution. Other neurostimulators may restrict the allowed MRI power or scan location, preventing imaging on your shoulders or vital organs in your torso. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Risk of depression, suicidal ideations, and suicide. Caution patients to not make unauthorized changes to physician-established stimulation parameters. Implantation at vertebral levels above T10. Implantation of multiple leads. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. Placing the IPG. To find Shipping Material Packaging Waste information, select Healthcare Professionals. Wireless use restrictions. 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. For complete and comprehensive MRI support, parameters, and precautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. Care and handling of components. If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals. Inserting the anchor. Follow proper infection control procedures. Use extreme care when handling system components. Additional Disadvantages. 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 . To prevent unintended stimulation, do not modify the operating system in any way. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training for dorsal root ganglion (DRG) neurostimulation systems. For this reason, programming at frequencies less than 30 Hz is not recommended. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. 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. Implantation of two systems. Providing strain relief. In patients who have areas of increased sensitivity to heat, consider placing the implant where the patient has normal sensation. Implanting physicians or anesthesiologists should consult practice guidelines for the intraoperative management of patients with diabetes. The long-term safety and effectiveness of this neurostimulation system has not been established beyond 5 years. 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. Electrosurgery. 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. Product materials. The safety and effectiveness of neurostimulation for pediatric use have not been established. Patients who failed to receive effective pain relief during trial stimulation are contraindicated to process to the permanent implant procedure. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. 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. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Scuba diving or hyperbaric chambers. Confirm that no adverse conditions to MR scanning are present. 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. Confirm implant locations and scan requirements for the patients system. 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. away from the generator and avoid placing any smart device in a pocket near the generator. Do not bring the suture needle in contact with an IPG, lead, or extension, or the component may be damaged. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. IPG placement. If the operating field is bloody, wipe gloves, lead, stylet, and sheath before handling the lead. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. *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. The clinician programmer and patient controller are not waterproof. Wireless use restrictions. Do not handle the generator if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. Operation of machines, equipment, and vehicles. Programmer use. Skin erosion. Safety has not been established for radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. Neuromodulation. For adverse effects observed in SCS clinical studies, refer to the clinical summaries manual for SCS systems. 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. Exposure to body fluids or saline. External defibrillation can cause induced currents in the leadextension portion of the neurostimulation system. Programmer and controller devices are not waterproof. If this date has been reached or has been exceeded before the date of implantation, the generator should be charged prior to implantation. Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. 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. Use caution when sedating the patient. Return any suspect components to Abbott Medical for evaluation. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. Clinician training. Skydiving, skiing, or hiking in the mountains. 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. Magnetic resonance imaging (MRI). Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. 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. The tip of the sheath may whip around and could cause harm to the patient. Unwanted changes in stimulation may include a jolting or shocking feeling. Number of leads implanted. Operation of machines, equipment, and vehicles. Sudden loss of stimulation may cause patients to fall or lose control of equipment or vehicles, injure others, or bring injury upon themselves. Storage environment. FDA's expanded . Prior to connection, exposure of the metal contacts, such as those on the connection end of a lead or extension, to body fluids or saline can lead to corrosion. 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. When multiple leads are implanted, route the lead extensions so the area between them is minimized. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. Use caution when securing the soft tissue anchor because damage to the anchor or lead can occur and result in failure of the system. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. If needed, return the equipment to Abbott Medical for service. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. Do not use the clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Always perform removal of implanted components with the patient conscious and able to give feedback. Infection. Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket. Do not use excessive pressure when injecting through the sheath. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. Case damage. When inserting the lead-sheath assembly through the needle into the epidural space, tighten the lead stabilizer to prevent lead migration out of the sheath. If a patient experiences new or worsening depression or suicidal ideation, manage these symptoms appropriately. If radiation therapy is required, the area over the implanted generator should be shielded with lead. 72750 MAT-2215018 v2.0 | Item approved for U.S. use only. The website that you have requested also may not be optimized for your screen size. The severity of any surgical complication may be greater in patients with diabetes, particularly those with inadequate pre-operative glycemic control. Follow proper infection control procedures. 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). 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. Using the tunneling tool. Output power below 80 W is recommended for all activations. Diathermy therapy. PDF View Shellock R & D Services, Inc. email: . 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). 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. Pediatric use. Overcommunicating with the IPG. 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. Do not suture directly onto the lead to avoid damaging the lead. 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. If lithotripsy must be used, do not focus the energy near the IPG. In rare cases, this can create a medical emergency. Before your patient undergoes an MRI scan: Confirm the MR Conditional components and location of the system. Exposure to body fluids or saline. Read this section to gather important prescription and safety information. 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. Bending the sheath. Therapeutic magnets (e.g., magnets used in pillows, mattress pads, back belts, knee braces, wrist bands, and insoles) may unintentionally cause the neurostimulation system to turn on or off. Conditional 5. During the implant procedure, if an electrosurgery device must be used, take the following actions:. Recharge-by date. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). 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. 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. Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. Operation of machinery and equipment. Infection. Introduction: Spinal cord stimulation is becoming an increasingly used modality for the treatment of chronic pain. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Emergency procedures. Avoid placing equipment components directly over other electronic devices. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Therapeutic radiation may damage the electronic circuitry of an implanted neurostimulation system, although no testing has been done and no definite information on radiation effects is available. 737202011056 v5.0 | Item approved for U.S. use only. With the Proclaim XR SCS system, you can have hassle-free pain relief with a battery that lasts up to 10 years at low-dose settings* without ever needing to charge the system. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. Do not place TENS electrodes so that the TENS current passes over any part of the neurostimulation system. Explosive and flammable gasses. Clinician training. Do not use the application if the operating system is compromised (that is, jailbroken). Component manipulation by patients. It is extremely important to select patients appropriately for neurostimulation. 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. The following precautions apply to this neurostimulation system. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. Diathermy is further prohibited because it may also damage the neurostimulation system components.
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