Poor surgical risks. Transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). 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. Patients who failed to receive effective pain relief during trial stimulation are contraindicated to process to the permanent implant procedure. 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. Always be aware of the needle tip position. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Clinician training. Diathermy is further prohibited because it may also damage the neurostimulation 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. Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. Poor surgical risks. Scuba diving or hyperbaric chambers. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. Cremation. January 4, 2022 By Sean Whooley. Before beginning a CT scan, the operator should use CT scout views to determine if implanted or externally worn electronic medical devices are present and if so, their location relative to the programmed scan range. Case damage. 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. 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. 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. Implantation of two systems. Explosive and flammable gasses. Do not crush, puncture, or burn the IPG because explosion or fire may result. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. 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. 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. Lead damage from tools. Use extreme care when handling system components. 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. 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. Safety has not been established for radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system. Additionally, all patients will be awake and conversant during the procedure to minimize the impact. 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. 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. If a patient experiences new or worsening depression or suicidal ideation, manage these symptoms appropriately. ); 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. 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. Patient training. Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. Remove leads slowly. To prevent injury or damage to the system, do not modify the equipment. In patients who have areas of increased sensitivity to heat, consider placing the implant where the patient has normal sensation. between lead ends is recommended); Verify that the neurostimulation system is not interfering with the function of the implanted cardiac system; and. Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation. 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. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. 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. Confirm implant locations and scan requirements for the patients system. Mobile phones. The following warnings apply to this neurostimulation system. Patients should avoid charging their generator over an incision that has not completely healed. 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. 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). Do not bend the sheath without the lead inside the sheath, as this will permanently kink it and make it difficult to deploy the lead. Consider bipolar programming of both devices and use neurostimulation system settings that do not interfere with the function of the implantable cardiac system. Emergency procedures. To prevent unintended stimulation, do not modify the operating system in any way. Sudden loss of stimulation may cause patients to fall or lose control of equipment or vehicles, injure others, or bring injury upon themselves. Package or component damage. Failure to do so may result in damage to the sheath. 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. 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. Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation. Handle the device with care. 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. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. Return them to Abbott Medical for proper disposal. Implant heating. Exposure to body fluids or saline. Before your patient undergoes an MRI scan: Confirm the MR Conditional components and location of the system. Both the Intellis and Vanta SCS devices integrate SureScan MRI technology, providing MRI access anywhere in the body with normal operating mode power settings. IPGs contain batteries as well as other potentially hazardous materials. Lead movement. Insertion of a sheath without the lead may result in dural puncture. Implantation of two systems. External defibrillators. Do not use the clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. Additional risks to the patients, as a result of the placement and stimulation of the lead in the area of the dorsal root ganglion (DRG), include pain from setting the stimulation parameters too high. Application modification. communication equipment (such as microwave transmitters and high-power amateur transmitters). Programmer use. Back pain. Patients should exercise reasonable caution when bathing. 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). 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). Neuromodulation. 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. Do not crush, puncture, or burn the IPG because explosion or fire may result. 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. Product materials. While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. The system can be programmed to use parameter settings outside the range of those used in the clinical studies. Pediatric use. INDICATIONS FOR USE Do not use the system if the use-before date has expired. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training. Place the neurostimulator in Surgery mode before using an electrosurgery device. The device should be turned off and the doctor contacted if this occurs. Computed tomography (CT). Failure to do so may cause harm to the patient such as damage to the dura. 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. 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. Conditional 5. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Placing the IPG. For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. If lithotripsy must be used, do not focus the energy near the IPG. Care and handling of components. Wireless use restrictions. Security, antitheft, and radiofrequency identification (RFID) devices. Use caution when sedating the patient. The placement of the leads involves some risk, as with any surgical procedure. Scuba diving and hyperbaric chambers. Before reinserting the sheath, verify there is no damage to the sheath. High-output ultrasonics and lithotripsy. 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. 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. Postural changes. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. An expiration date (or use-before date) is printed on the packaging. Keep them dry to avoid damage. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. NOTE: During intraoperative testing, Surgery mode must be turned off for the neurostimulation system to function correctly. 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. six to eight weeks after implantation of a neurostimulation system. Confirm the neurostimulation system is functioning correctly after the procedure. Do not use the application if the operating system is compromised (that is, jailbroken). In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Especially consider the following additional factors when selecting patients: Level of available support from a caregiver. When using a contralateral approach, advance the needle slowly into the epidural space and take caution as it enters. 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. Do not crush, puncture, or burn these devices because explosion or fire may result. The safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established. 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. 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, cause heating at the lead tip that could result in tissue damage, and induce voltage through the lead that could jolt or shock the patient. Unlike other SCS systems, the ProclaimXR SCS system is recharge free. Pregnancy and nursing. Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system. Maximize the distance between the implanted systems (minimum separation distance of approximately 8 cm (3 in.) To prevent unintended stimulation, do not modify the operating system in any way. Spinal cord stimulation of the dorsal root ganglion for groin pain-a retrospective review. 72184 MAT-2214513 v1.0 | Item approved for U.S. use only. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. 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. Damage to the system may not be immediately detectable. If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals. If unpleasant sensations occur, turn off stimulation immediately. Scuba diving or hyperbaric chambers. 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. Damage to shallow implants. Battery care. 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. Infection. away from the generator and avoid placing any smart device in a pocket near the generator. Electrosurgery. 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. Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. Inaccurate ECG results may lead to inappropriate treatment of the patient. External defibrillators. Clinician training. The clinician programmer and patient controller are not waterproof. 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. The severity of any surgical complication may be greater in patients with diabetes, particularly those with inadequate pre-operative glycemic control. Radiofrequency or microwave ablation. Store components and their packaging where they will not come in contact with liquids of any kind. The equipment is not serviceable by the customer. If the patient requires a CT scan, all stimulation should be turned off before the procedure. If the stylet is removed from the lead, it may be difficult to reinsert it. Storage environment. 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. Unwanted changes in stimulation may include a jolting or shocking feeling. Stabilizing the lead during insertion. Patients will receive an identification card to carry with them that will inform emergency medical personnel of their implanted system. Stimulation in unwanted places (such as radicular stimulation of the chest wall), Lead migration, causing changes in stimulation or reduced pain relief, Epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement of a lead in the epidural space, Paralysis, weakness, clumsiness, numbness, or pain below the level of the implant, Persistent pain at the electrode or generator site, Seroma (mass or swelling) at the generator site, Allergic or rejection response to implant materials, Implant migration or skin erosion around the implant. Activities requiring excessive twisting or stretching. A risk of brain tissue damage exists with parameter settings using high amplitudes and wide pulse widths. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. **Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia as complex regional pain syndrome (CRPS) types I and II, respectively. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. Sheath rotation. 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. 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. 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.