Patients should take reasonable care to avoid devices that generate strong EMI, which may cause the neurostimulation system to unintentionally turn on or off. Inaccurate ECG results may lead to inappropriate treatment of the patient. Operation of machines, equipment, and vehicles. Advise patients to not use their device when engaging in activities that might cause it to get wet, such as swimming or bathing. 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.). Sheath retraction. Read this section to gather important prescription and safety information. It is extremely important to select patients appropriately for neurostimulation. 72750 MAT-2215018 v2.0 | Item approved for U.S. use only. To correct the effect of interference with other devices, turn off the equipment or increase the distance between the equipment and the device being affected. Programmer and controller devices are not waterproof. Control of the patient controller. The Prodigy MRI SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott's smallest implantable pulse generator (IPG). Surgical advice for removal. 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. Abbott's Prodigy, Proclaim, and Proclaim XR SCS Systems are used to help manage chronic, intractable pain of the trunk and/or limbs, including one-sided or two-sided pain associated with the . Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Implantation at vertebral levels above T10. Bending the sheath. Risk of depression, suicidal ideations, and suicide. If the operating field is bloody, wipe gloves, lead, stylet, and sheath before handling the lead. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. Implantation of two systems. (2) The method of its application or use. If a system does not meet the MR Conditional requirements, consider it MR Unsafe. Return of symptoms and rebound effect. 71409MAT-2116350 v4.0 | Item approved for U.S. use only. Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. 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. Use extreme care when removing the lead stylet, the delivery sheath, and the needle to ensure that the distal tip of the lead remains in the desired location. A summary of the safety and clinical performance (SSCP) for these devices will be published at https://ec.europa.eu/tools/eudamed by the Notified Bodies in accordance with the requirements of EU MDR 2017/745 and associated timelines. Expected effect from cessation of therapy, should disease symptoms return unexpectedly. Clinician training. Keep the device dry. Implantation of two systems. 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. Therapeutic radiation. Explosive and flammable gasses. Wireless use restrictions. Electrosurgery. Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket. If radiation therapy is required, the area over the implanted generator should be shielded with lead. Do not crush, puncture, or burn these devices because explosion or fire may result. 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). 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 . 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. 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. commercial electrical equipment (such as arc welders and induction furnaces). 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. These activities include but are not limited to climbing ladders and operating potentially dangerous machinery, power tools, and vehicles. If unpleasant sensations occur, the device should be turned off immediately. 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. External defibrillators. High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. 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. External defibrillators. Insertion of a sheath without the lead may result in dural puncture. Clinician training. 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 U.S. Food and Drug Administration (FDA) approved Abbott's Eterna spinal cord stimulation (SCS) system for the treatment of chronic pain This neuromodulation device provides an optimized experience with the ability to wirelessly charge as few as five times per year, the lowest recharge burden compared to other rechargeable SCS systems 1,2,3 PDF View Shellock R & D Services, Inc. email: . Proclaim XR SCS System Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. Patients should cautiously approach such devices and should request help to bypass them. Stabilizing the lead during insertion. 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. Low frequencies. Securing the IPG. Sheath insertion precaution. However, advise patients who feel uncomfortable paresthesia during postural changes that they should not operate potentially dangerous equipment such as power tools, automobiles, or other motor vehicles. Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. 74372 MAT-2215216 v3.0 | Item approved for U.S. use only. Device modification. Why Proclaim XR SCS System - Abbott 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. Patients should exercise reasonable caution when participating in activities that require coordination, including those that they were able to perform prior to receiving DBS therapy (for example, swimming). (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Consider seeking surgical advice if you cannot easily remove a lead. If the packaging has been compromised, the device is beyond its expiration date, or the sterile package or device show signs of damage, do not use the device as it may be compromised and could cause harm to the patient. Abbott's Proclaim XR Spinal Cord Stimulation System Now Offers Expanded MRI Compatibility in U.S. - New U.S. FDA-approved labeling lifts restrictions on 60-centimeter Octrode leads, which are implanted, electrically insulated wires that transmit electrical impulses to the target nerves Poor surgical risks. If the neurostimulator is on during an ECG, the ECG recording may be adversely affected, resulting in inaccurate ECG results. Skin erosion. Pediatric use. 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. Lead handling. Charge density can be reduced by lowering the stimulation amplitude or pulse width. The following procedures are contraindicated for patients that have been implanted with this device: Diathermy therapy. If a patient experiences new or worsening depression or suicidal ideation, manage these symptoms appropriately. The placement of the leads involves some risk, as with any surgical procedure. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. Abandoned leads and replacement leads. 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 effect of other implanted devices, including deep brain stimulators, peripheral nerve stimulators, implanted drug delivery pumps, and cochlear implants on the neurostimulation system are unknown. Single-use, sterile device. Have the patient check the device for proper functioning, even if the device was turned off. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Return them to Abbott Medical for proper disposal. Infection. For complete and comprehensive MRI support, parameters, and precautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for six to eight weeks after implantation of a neurostimulation system. Pregnancy and nursing. 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. 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. separates the implanted generators to minimize unintended interaction with other system components. High stimulation outputs and charge density limits. High-output ultrasonics and lithotripsy. Placement of lead connection in neck. 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. Thorough psychiatric screening should be performed. separates the implanted IPGs to minimize unintended interaction with other system components. Operation of machinery and equipment. IPG disposal. If the stylet is removed from the lead, it may be difficult to reinsert it. Conversely, the other active implanted device may interfere with the operation of the neurostimulation system. away from the generator and avoid placing any smart device in a pocket near the generator. Neurostimulation should not be used on patients who are poor surgical candidates. Poor surgical risks. If two systems are implanted, ensure that at least 20 cm (8 in.) The Eterna SCS System is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation. Advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan. Exit Surgery mode during intraoperative testing and after the procedure is completed. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. The device should be turned off and the doctor contacted if this occurs. INDICATIONS FOR USE 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. 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. 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). Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted. Patient selection. Clinicians should be familiar with deep brain stimulation therapy and be experienced in the diagnosis and treatment of the indication for which the deep brain stimulation components are being used. Physicians should also discuss any risks of MRI with patients. Store components and their packaging where they will not come in contact with liquids of any kind. 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. These patients should not climb ladders or participate in activities where postural changes or abrupt movements could alter the perception of stimulation intensity and cause patients to fall or lose control of equipment or vehicles or injure others. Patient's physical ability, as patients with higher degrees of motor impairment might have difficulty with the physical requirements of monitoring the device. Confirm that the neurostimulation system is functioning correctly during the implant procedure, before closing the neurostimulator pocket, and after the implant procedure. Store components and their packaging where they will not come in contact with liquids of any kind. Patients who are unable to properly operate the system. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. To prevent injury or damage to the system, do not modify the equipment. 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. MRI SUPPORT - PROCLAIM DRG - neuromodulation.abbott Proclaim XR Spinal Cord Stimulation (SCS) System, Model 3660 and Model 3662 . All components listed must be implanted unless noted as "optional." Note: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. 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. Infection. To prevent unintended stimulation, do not modify the operating system in any way. High altitudes should not affect the neurostimulator; however, the patient should consider the movements involved in any planned activity and take precautions to avoid putting undue stress on the implanted system. Avoid placing equipment components directly over other electronic devices. Bold New Spinal Cord Stimulation - Proclaim XR SCS System Stimulation Modes. If lithotripsy must be used, do not focus the energy near the IPG. Expiration date. Safety has not been established for radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system. 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. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. 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. The equipment is not serviceable by the customer. Diathermy is further prohibited because it may also damage the neurostimulation system components. Abbott's Proclaim XR Spinal Cord Stimulation System Now Offers Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards. Consider bipolar programming of both devices and use neurostimulation system settings that do not interfere with the function of the implantable cardiac system. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. 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. Patient's visual ability to read the patient controller screen. Pressures below 30 m (100 ft.) of water (or above 4.0 ATA) could damage the neurostimulation system. 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. Battery care. 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. Remove leads slowly (at a suggested rate of 1 cm/s while holding the lead between the thumb and forefinger) to avoid breaking the lead and leaving fragments in the patient. 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. 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. Scuba diving or hyperbaric chambers. The effect of mobile phones on deep brain stimulation is unknown. Injury or damage can occur during diathermy treatment whether the neurostimulation system 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. Security, antitheft, and radiofrequency identification (RFID) devices. Infections related to system implantation might require that the device be explanted. Lead movement. Object Info: - MRI Safety Do not use the clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Therapeutic radiation. 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. If the sheath has been kinked during delivery, slowly retract through the needle with the curve facing the same direction as the bevel. If unpleasant sensations occur, turn off stimulation immediately. External defibrillation can cause induced currents in the lead-extension portion of the neurostimulation system. 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. radiofrequency identification (RFID) devices. Return any suspect components to Abbott Medical for evaluation. Restricted areas. Overcommunicating with the IPG. 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. 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. 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. 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. If needed, return the equipment to Abbott Medical for service. Always be aware of the needle tip position. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for at least six weeks after implantation. To correct the effects of typical interference, keep wireless communication equipment at least 15 cm (6 in) from the IPG. Complete any electrosurgery before connecting the leads or extensions to the neurostimulator. Component disposal. Placing the IPG. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. Multiple leads. The implanted components of this neurostimulation system are intended for a single use only. Up to two IPGs, leads, extensions, and burr hole covers may be implanted. The following warnings apply to this neurostimulation system. 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. Conditional 5. Electromagnetic interference (EMI). During the implant procedure, if an electrosurgery device must be used, take the following actions:. High-output ultrasonics and lithotripsy. Needle positioning. Confirm the neurostimulation system is functioning. The system can be programmed to use parameter settings outside the range of those used in the clinical studies. Care and handling of components. This means you can get hassle-free pain relief with a battery that lasts up to 10 years at low-dose settings** without ever needing to charge the system. Patients should also avoid any activities that would be potentially unsafe if their symptoms were to return unexpectedly. Component manipulation. Consumer goods and electronic devices. Sheath insertion warning. However, current data shows that most patients using BurstDR Stimulation Therapy do not experience paresthesia. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. Surgical complications and adverse events may be more frequent and severe in patients with diabetes. Failure to do so may result in difficulty delivering the lead. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. After defibrillation, confirm the neurostimulation system is still working. Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura. To find Shipping Material Packaging Waste information, select Healthcare Professionals. Physicians should also discuss any risks of MRI with patients. 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. Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the management of disabling tremor. Infections related to system implantation might require that the device be explanted. If the lead extensions are routed in a loop, the loop will increase the potential for electromagnetic interference (EMI). Patient selection. The safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established. 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). Do not handle the generator if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. 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. Scanning under different conditions may cause device malfunction, severe patient injury, or death. Neuromodulation | For Consumers | Abbott U.S. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. 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. 72784 MAT-2215217 v2.0 | Item approved for U.S. use only. Confirm implant locations and scan requirements for the patients system. Activities requiring excessive twisting or stretching. Sheath rotation. Electrocardiograms. Approved models and implant locations for an MR Conditional full system, *The IPG port plug associated with these models is also an MR Conditional component. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. Before reinserting the sheath, verify there is no damage to the sheath. Patient training. Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment. 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. Abbott's Proclaim XR Spinal Cord Stimulation System Now Offers Expanded MRI Compatibility in U.S. - New U.S. FDA-approved labeling lifts restrictions on 60-centimeter Octrode leads,. 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. 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. Mobile phones. 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. New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. Neurostimulation should not be used for patients with comorbidities that could prevent successful implant or effective therapy. 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). Damage to the system may not be immediately detectable.