Surgical advice for removal. 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 this date has been reached or has been exceeded before the date of implantation, the generator should be charged prior to implantation. Always perform removal of implanted components with the patient conscious and able to give feedback. 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. (2) The method of its application or use. If lithotripsy must be used, do not focus the energy near the generator. INDICATIONS FOR USE The IPG should be explanted before cremation because the IPG could explode. 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. For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual. Advise your patient to avoid manipulating the implanted system components (e.g., the neurostimulator, the burr hole site). 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. 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). 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. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. Using the tunneling tool. 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. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. Single-use, sterile device. The Proclaim XR SCS system can provide relief to . If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. If unpleasant sensations occur, the device should be turned off immediately using the patient magnet. The effect of mobile phones on deep brain stimulation is unknown. Diathermy is further prohibited because it may also damage the neurostimulation system components. 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. Inaccurate ECG results may lead to inappropriate treatment of the patient. Therefore, physicians should consider the following: Preoperatively, assess patients for the risks of depression and suicide. Electromagnetic interference (EMI). Confirm that the neurostimulation system is functioning correctly during the implant procedure, before closing the neurostimulator pocket, and after the implant procedure. Schu S, Gulve A, ElDabe S, et al. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. The following procedures are contraindicated for patients that have been implanted with this device: Diathermy therapy. 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, intractable low back and leg pain, and diabetic peripheral neuropathy of the lower extremities. Explosive or flammable gasses. Patients should cautiously approach such devices and should request help to bypass them. Exposure to body fluids or saline. 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. Electromagnetic interference (EMI). Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Other neurostimulators may restrict the allowed MRI power or scan location, preventing imaging on your shoulders or vital organs in your torso. separates the implanted IPGs to minimize unintended interaction with other system components. The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. Needle insertion. High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. Before reinserting the sheath, verify there is no damage to the sheath. Surgical complications and adverse events may be more frequent and severe in patients with diabetes. Return them to Abbott Medical for proper disposal. Infections related to system implantation might require that the device be explanted. 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. Lead insertion through sheath. 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. Securing the anchor. 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. Long-term safety and effectiveness. 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. Damage to the system may not be immediately detectable. If the implanted system contains components or models not listed in the followingtable, then the system is considered MR Unsafe. radiofrequency identification (RFID) devices. If unpleasant sensations occur, the device should be turned off immediately. Conditional 5. 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. Care and handling of components. The Proclaim XR implantable pulse generator (IPG) is a novel device designed to supply low-dose BurstDR stimulation in a primary cell battery guaranteed to last 5-10 years with appropriate programming. PATIENTS 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. Make the Bold Choice Operation of machines, equipment, and vehicles. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. It's small, discreet and available with Abbott's proprietary BurstDR stimulation, a new technology that's clinically proven to . Physicians should also discuss any risks of MRI with patients. 72784 MAT-2215217 v2.0 | Item approved for U.S. use only. 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. 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. 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. Ensure the patients neurostimulation system is in MRI mode. If the programming of stimulation parameters exceeds the charge density limit of 30 C/cm2, a screen will appear warning you that the charge density is too high. Do not crush, puncture, or burn the generator because explosion or fire may result. separates the implanted generators to minimize unintended interaction with other system components. Our Invisible Trial System TM is a discreet, app . 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. Do not over-manipulate the sheath and lead system as this may result in trauma within the epidural space. Security, antitheft, and radiofrequency identification (RFID) devices. To prevent injury or damage to the system, do not modify the equipment. Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment. Equipment is not serviceable by the customer. Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. 74372 MAT-2215216 v3.0 | Item approved for U.S. use only. Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. 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. Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. 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. commercial electrical equipment (such as arc welders and induction furnaces). Use fluoroscopy and extreme care when inserting, advancing, or manipulating the guidewire or lead in the epidural space to minimize the risk of a dural tear. Storage environment. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the management of disabling tremor. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief. If multiple leads are implanted, leads and extensions should be routed in close proximity. Clinician programmers, patient controllers, and chargers are not waterproof. Lead inspection. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. 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. Perception of higher levels of stimulation has been described by some patients as uncomfortable, painful, or jolting. 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. See Full System Components below if the patient has an IPG and extensions implanted. The safety and efficacy of implantation of leads implanted above the T10 vertebral level have not been evaluated. Damage to the system may not be immediately detectable. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Return the explanted IPG to Abbott Medical. Avoid placing equipment components directly over other electronic devices. Preventing infection. The use of high-output devices, such as an electrohydraulic lithotriptor, may damage the electronic circuitry of an implanted generator. Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket. Patients should not dive below 30 m (100 ft) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). If lithotripsy must be used, do not focus the energy near the IPG. This system is contraindicated for patients who meet the following criteria: The following procedures are contraindicated for patients with a deep brain stimulation system. Cremation. Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control. Battery precaution. Confirm that no adverse conditions to MR scanning are present. Expected effect from cessation of therapy, should disease symptoms return unexpectedly. 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. Abbott's neurostimulation therapies are designed to alter those signals as they travel to the brain, and minimize how you perceive pain.3 PROVEN SAFE AND EFFECTIVEWITH BENEFITS BEYOND PAIN RELIEF2, 4 One of the advantages of neurostimulation is that you can try the therapy using a temporary system before committing to an implanted system. 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). Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. Failure to do so may cause harm to the patient such as damage to the dura. 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. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. During the implant procedure, if an electrosurgery device must be used, take the following actions:. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the 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. Neuromodulation. between lead ends is recommended); Verify that the neurostimulation system is not interfering with the function of the implanted cardiac system; and. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. The safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established. Stabilizing the lead during insertion. Patients should cautiously approach such devices and should request help to bypass them. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. The following additional considerations should be made for patients with diabetes: A pre-operative risk assessment should be performed for patients with diabetes who are at high risk for ischemic heart disease, those with autonomic neuropathy or renal failure, and patients with a Hemoglobin A1C (HbA1c) 8% (64 mmol/mol). External defibrillation can cause induced currents in the lead-extension portion of the neurostimulation system. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). 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. Patient's physical ability, as patients with higher degrees of motor impairment might have difficulty with the physical requirements of monitoring the device. If the stylet is removed from the lead, it may be difficult to reinsert it. Nonadjacent leads and extensions have the possibility of creating a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. 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. Patients should cautiously approach such devices and should request help to bypass them. Component disposal. Keep programmers and controllers dry. 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 some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. Bending the sheath. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system. Package or component damage. 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. The operation of these devices could cause them to ignite, causing severe burns, injury, or death. 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. Use extreme care when handling system components. Consider seeking surgical advice if you cannot easily remove a lead. When multiple leads are implanted, route the lead extensions so the area between them is minimized. The operation of the clinician programmer or patient controller could cause them to ignite, causing severe burns, injury, or death. If any component of the implanted neurostimulation system, such as an IPG, lead, or extension, does not meet the requirements for an MR Conditional system, do not perform an MRI scan. Therapeutic radiation. Transcutaneous electrical nerve stimulation (TENS). Activities requiring excessive twisting or stretching. Do not suture directly onto the lead to avoid damaging the lead. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system: Other active implanted devices. FDA's expanded . Magnetic resonance imaging (MRI). Carefully inspect the lead (in the sterile field) for damage after removing it from the sterile package. Device modification. High stimulation outputs and charge density limits. 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. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Return all explanted components to Abbott Medical for safe disposal. Skin erosion. Patients should take reasonable care to avoid devices that generate strong EMI, which may cause the neurostimulation system to unintentionally turn on or off. Lead movement. 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.