If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. If lithotripsy must be used, do not focus the energy near the IPG. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Interference with other devices. Cremation. 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. Consumer goods and electronic devices. Additionally, all patients will be awake and conversant during the procedure to minimize the impact. Keep dry to avoid damage. 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. six to eight weeks after implantation of a neurostimulation system. Up to two leads, lead protection boots, and burr hole covers may be implanted. If they must go through a gate or doorway containing this type of device, patients should turn off their generator and proceed with caution, being sure to move through the device quickly. Do not crush, puncture, or burn the IPG because explosion or fire may result. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. 72750 MAT-2215018 v2.0 | Item approved for U.S. use only. Keep them dry to avoid damage. Instruct patients to contact their physician if they experience any adverse effects, such as unusual pain or discomfort during stimulation and swelling, redness, tenderness, or pain around implanted components. 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. Ask patients with neurostimulators to shut off the device temporarily while the scan is performed. 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. 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. 737202011056 v5.0 | Item approved for U.S. use only. 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. Component manipulation by patient. Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation. Patient's visual ability to read the patient controller screen. and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). Patients should avoid activities that may put undue stress on the implanted components of the neurostimulation system. The Proclaim XR SCS System is an implantable spinal cord stimulation device designed to allow patients to attain relief from chronic pain of the trunk and limbs. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Wireless use restrictions. 21 CR 801.109(b) The label of the device, other than surgical instruments, bears: (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. ); complications from unusual physiological variations in patients, including foreign body rejection phenomena; paralysis (loss of motor function, inability to move); Possible deep brain stimulation complications. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. 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. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. Read this section to gather important prescription and safety information. Keep the device dry. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. commercial electrical equipment (such as arc welders and induction furnaces). 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 use short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. Return of symptoms and rebound effect. 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. 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. For this reason, programming at frequencies less than 30 Hz is not recommended. If lithotripsy must be used, do not focus the energy near the IPG. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or render the patient incapable of controlling the generator. Failure to do so may result in damage to the sheath. 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. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. If needed, return the equipment to Abbott Medical for service. Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards. Pediatric use. The patient must be instructed to not rub or exert pressure on implanted components through the skin as this may cause lead dislodgement leading to stimulation at the implant site, IPG inversion leading to the inability to communicate with the device, or skin erosion that can lead to another surgical procedure or possible infection. Operation of machines, equipment, and vehicles. Instruct patients to use their neurostimulation system only after an authorized clinician has programmed the device and has trained the patient how to control stimulation and safely use the system. Only apply software updates that are published directly by Abbott Medical. Careful consideration should be used before using radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system since safety has not been established. Patients should cautiously approach such devices and should request help to bypass them. 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. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. Securing the anchor. Use caution when securing the soft tissue anchor because damage to the anchor or lead can occur and result in failure of the system. Return all explanted generators to Abbott Medical for safe disposal. For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. To correct the effects of typical interference, keep wireless communication equipment at least 15 cm (6 in) from the IPG. 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. Security, antitheft, and radiofrequency identification (RFID) devices. Back pain. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. Wireless use restrictions. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Long-term safety and effectiveness. Advancing components. Do not use surgical instruments to handle the lead. 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. Diathermy therapy. Placing the IPG. Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient. Case damage. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. Patients should be advised to not use therapeutic magnets. Inaccurate ECG results may lead to inappropriate treatment of the patient. Electromagnetic interference (EMI). 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. 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. Always be aware of the needle tip position. Consumer goods and electronic devices. Pregnancy and nursing. 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. All components listed must be implanted unless noted as "optional." 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. Bending the sheath. INTENDED USE This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. The Prodigy MRI SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott's smallest implantable pulse generator (IPG). Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. Infection. Activities requiring excessive twisting or stretching. While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. Store components and their packaging where they will not come in contact with liquids of any kind. Clinician programmers, patient controllers, and chargers are not waterproof. 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). The safety and effectiveness of neurostimulation for pediatric use have not been established. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). 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. Radiofrequency or microwave ablation. The following precautions apply to this neurostimulation system. 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. Neurostimulation should not be used for patients with comorbidities that could prevent successful implant or effective therapy. The device should be turned off and the doctor contacted if this occurs. Physicians should also discuss any risks of MRI with patients. This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. The safety and efficacy of implantation of leads implanted above the T10 vertebral level have not been evaluated. The abrupt cessation of stimulation for any reason will probably cause disease symptoms to return. 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. Sheath retraction. Anchoring leads. Avoid excessive stimulation. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) Patients should also avoid any activities that would be potentially unsafe if their symptoms were to return unexpectedly. 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. Keep them dry to avoid damage. 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. Follow proper infection control procedures. For adverse effects observed in SCS clinical studies, refer to the clinical summaries manual for SCS systems. Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system. If the patient requires a CT scan, all stimulation should be turned off before the procedure. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. Before your patient undergoes an MRI scan: Confirm the MR Conditional components and location of the system. The force of the instruments may damage the lead or stylet. Lead movement. 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. Surgeon training. Stimulation Modes. Implantation of multiple leads. 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. Emergency procedures. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. Needle insertion. 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. Using surgical instruments. Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. 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. Do not use excessive pressure when injecting through the sheath. 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. Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. Patients should exercise reasonable caution when bathing. Proclaim Plus Spinal Column Stimulation (SCS) System PRESCRIPTION AND SAFETY INFORMATION Read this section to gather important prescription and safety information. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. Case damage. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems. 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. Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible. Closely monitor patients for signs of infection, delayed wound healing, or cerebrospinal fluid (CSF) leakage as the severity of these complications may be greater in patients with diabetes. PDF View Shellock R & D Services, Inc. email: . Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. Detailed information on storage environment is provided in the appendix of this manual. Package or component damage. Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control. System testing. If the operating field is bloody, wipe gloves, lead, stylet, and sheath before handling the lead. Explosive or flammable gasses. Select patients appropriately for deep brain stimulation. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. IPGs contain batteries as well as other potentially hazardous materials. 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. Confirm that the neurostimulation system is functioning correctly during the implant procedure, before closing the neurostimulator pocket, and after the implant procedure. Confirm the neurostimulation system is functioning correctly after the procedure. Object Category Spinal Cord Stimulation Systems: St. Jude Medical. Ensure the neurostimulator is off before initiating an electrocardiogram (ECG). 74372 MAT-2215216 v3.0 | Item approved for U.S. use only. Pregnancy and nursing. Battery care. We offer products that are MR Conditional for spinal cord stimulation (SCS) and dorsal root ganglion (DRG) therapy. Store components and their packaging where they will not come in contact with liquids of any kind. During the 2000s about a dozen companies sold and manufactured SCS systems worldwide, including the "big three" (Boston Scientific, Abbott/St. Return them to Abbott Medical for proper disposal. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. Ensure the patients neurostimulation system is in MRI mode. For complete MRI guidance, parameters and cautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. Do not use a clinician programmer or patient controller around explosive or flammable gas fumes or vapors. Stabilizing the lead during insertion. Neuromodulation. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. If the stylet is removed from the lead, it may be difficult to reinsert it. Stimulation effectiveness. 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. Stimulation frequencies at less than 30 Hz may cause tremor to be driven (meaning that tremor occurs at the same frequency as the programmed frequency). Abandoned leads and replacement leads. Pain is not resolved. Mobile phones. Approved models and implant locations for an MR Conditional lead-only system. If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals. The IPG should be explanted before cremation because the IPG could explode. Radiofrequency or microwave ablation. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. This includes oxygen-enriched environments such as hyperbaric chambers. 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. 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. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. Sheath rotation. Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinsons disease. All components listed must be implanted unless noted as "optional." 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. Diathermy is further prohibited because it may also damage the neurostimulation system components.

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