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. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. To ensure correct operation, always test the system during the implant procedure, before closing the neurostimulator pocket, and before the patient leaves the surgery suite. If the lead extensions are routed in a loop, the loop will increase the potential for electromagnetic interference (EMI). 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. Lead damage from tools. Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. A recharge-by date is printed on the packaging. Transcutaneous electrical nerve stimulation (TENS). This may occur once the lead is in place and is connected to the neurostimulator and activated. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. In some cases, symptoms may return with a greater intensity than what a patient experienced before system implantation (rebound effect). Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards. Infection. The safety and effectiveness of neurostimulation for pediatric use have not been established. Failure to provide strain relief may result in lead migration requiring a revision procedure. Implantation of multiple leads. Patient training. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Care and handling of components. six to eight weeks after implantation of a neurostimulation system. 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. 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. The severity of any surgical complication may be greater in patients with diabetes, particularly those with inadequate pre-operative glycemic control. ), 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 or breakage, Stimulation in unwanted places (such as stimulation of the chest wall), Epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement of a lead in the epidural space Cerebrospinal fluid (CSF) leakage, Paralysis, weakness, clumsiness, numbness, sensory loss, or pain below the level of the implant, Pain or bleeding where the needle was inserted, Seroma (mass or swelling) at the implant site, Allergic or rejection response to device or implant materials, Hardware malfunction that requires replacing the neurostimulator, Pain from a noninjurious stimulus to the skin or an exaggerated sense of pain, Formation of reactive tissue in the epidural space around the lead, which can cause delayed spinal cord compression and paralysis and requires surgical intervention (Time to onset can range 23 from weeks to many years after implant.). Sheath retraction. Application modification. 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 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. After CT scanning directly over the implanted or externally worn electronic medical device: Have the patient turn the device back on if it had been turned off prior to scanning. Advance the needle and guidewire slowly. 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. 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. Set the electrosurgery device to the lowest possible energy setting. Implantation of two systems. Nerve damage may result from traumatic or surgical nerve injury. 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). Confirm that no adverse conditions to MR scanning are present. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. For this reason, programming at frequencies less than 30 Hz is not recommended. Surgical complications include, but are not limited to, the following: intracranial hemorrhage (which can lead to stroke, paralysis, or death); cerebrospinal fluid leakage or cerebrospinal fluid abnormality; persistent pain at surgery site or IPG site; brachial plexus injury (nerves to chest, shoulder and arm); postoperative pain, stress, or discomfort; hemiparesis (muscular weakness or partial paralysis on one side of body); ballism or hemiballism (uncontrollable movements on both or only one side of the body); confusiontransient, nocturnal or ongoing; cognitive impairment, including delirium, dementia, disorientation, psychosis and speech difficulties; pulmonary embolism (sudden blood vessel obstruction); aborted procedures (air embolism, unable to find target, surgical complication, etc. 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. Neurosurgery Pain Management Orthopaedic Surgery During the implant procedure, if an electrosurgery device must be used, take the following actions:. For more information, see the clinician programmer manual. 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. Consumer goods and electronic devices. This system is contraindicated for patients who meet the following criteria: The following procedures are contraindicated for patients with a deep brain stimulation system. Do not use a clinician programmer or patient controller around explosive or flammable gas fumes or vapors. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. Patients should cautiously approach such devices and should request help to bypass them. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. 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. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. Do not crush, puncture, or burn these devices because explosion or fire may result. 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. Handle the device with care. In addition to those risks commonly associated with surgery, the following risks are associated with implanting or using this neurostimulation system: Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs; if either occurs, turn off your IPG immediately, 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, Persistent pain at the electrode or IPG site, Seroma (mass or swelling) at the IPG site. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training for dorsal root ganglion (DRG) neurostimulation systems. 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 use the application if the operating system is compromised (i.e., jailbroken). If needed, return the equipment to Abbott Medical for service. Placement of lead connection in neck. 72784 MAT-2215217 v2.0 | Item approved for U.S. use only. 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. 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. Lead movement. Patients should be aware that during skydiving, the sudden jerking that occurs when the parachute opens may cause lead dislodgement or fractures, which may require surgery to repair or replace the lead. To prevent unintended stimulation, do not modify the operating system in any way. Therapeutic magnets. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. IPG disposal. Surgeon training. Cremation. Therefore, physicians should consider the following: Preoperatively, assess patients for the risks of depression and suicide. 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. Patients should not operate potentially dangerous machinery, power tools, or vehicles or engage in any activity that could be unsafe if their symptoms were to unexpectedly return. Pediatric use. Device modification. Use extreme care when handling system components prior to implantation. Explosive or flammable gasses. 74373 MAT-2300644 v2.0 | Item approved for U.S. use only. Advise patients to not use their device when engaging in activities that might cause it to get wet, such as swimming or bathing. If the implanted system contains components or models not listed in the followingtable, then the system is considered MR Unsafe. 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. Do not crush, puncture, or burn the IPG because explosion or fire may result. 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. To prevent injury or damage to the system, do not modify the equipment. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. Battery care. 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. Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Stimulation effectiveness. The long-term safety and effectiveness of this neurostimulation system has not been established beyond 5 years. 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. 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. 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). 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. Patient selection. Damage to the system may not be immediately detectable. 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. Other neurostimulators may restrict the allowed MRI power or scan location, preventing imaging on your shoulders or vital organs in your torso. Devices with one-hour recharge per day. Physicians need to be aware of the risk and possible interaction between a neurostimulation system and an implanted cardiac system, such as a pacemaker or defibrillator. Especially consider the following additional factors when selecting patients: Level of available support from a caregiver. Use caution when sedating the patient. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system. 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. Securing the IPG. Abandoned leads and replacement leads. FDA's expanded . The IPG should be placed into the pocket, at a depth not to exceed 4 cm (1.57 in), with the logo side facing toward the skin surface. Wireless use restrictions. IPG placement. 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. 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. Component manipulation by patient. Radiofrequency or microwave ablation. 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. However, current data shows that most patients using BurstDR Stimulation Therapy do not experience paresthesia. All components listed must be implanted unless noted as "optional." Use appropriate sterile technique when implanting leads and the IPG. 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. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. Application modification. Mobile phones. 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. 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. 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. Wireless use restrictions. Ultrasonic scanning equipment. It's small, discreet and available with Abbott's proprietary BurstDR stimulation, a new technology that's clinically proven to . To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. January 4, 2022 By Sean Whooley. This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. Advancing components. Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. Consider bipolar programming of both devices and use neurostimulation system settings that do not interfere with the function of the implantable cardiac system. The system is intended to be used with leads and associated extensions that are compatible with the system. If two systems are implanted, ensure that at least 20 cm (8 in.) 737202011056 v5.0 | Item approved for U.S. use only. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted. Component manipulation by patients. Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient. Do not place TENS electrodes so that the TENS current passes over any part of the neurostimulation system. Dural puncture can occur if needle or guidewire is advanced aggressively once loss of resistance is achieved. Bending the sheath. This neurostimulation system is contraindicated for patients who are. Caution patients to not make unauthorized changes to physician-established stimulation parameters. Stimulation Modes. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Ask patients with neurostimulators to shut off the device temporarily while the scan is performed. Sources of therapeutic radiation include therapeutic X-rays, cobalt machines, and linear accelerators. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. If radiation therapy is required, the area over the implanted generator should be shielded with lead. Household appliances. Clinician programmers, patient controllers, and chargers are not waterproof. Infections related to system implantation might require that the device be explanted. 74372 MAT-2215216 v3.0 | Item approved for U.S. use only. Neuromodulation. Wireless use restrictions. Exposure to body fluids or saline. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. If two systems are implanted, ensure that at least 20 cm (8 in) separates the implanted IPGs to minimize unintended interaction with other system components. Using the tunneling tool. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. Securing the lead with the lead stabilizer will mitigate this risk. 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.
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