Always be aware of the needle tip position. Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation. Thorough psychiatric screening should be performed. Clinician training. Removing each item in slow movements while holding the remaining components in place will assist this process. Using surgical instruments. Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket. Implantation of this neurostimulation system is contraindicated for the following: Patients for whom test stimulation is unsuccessful. See Full System Components below if the patient has an IPG and extensions implanted. 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. 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. Operation of machinery and equipment. Patients with implanted Abbott leads should avoid scuba diving in more than 30 m (100 ft) of water or entering hyperbaric chambers above 4.0 atmospheres absolute (ATA) for any length of time, as this may damage the neurostimulation system. Remove the stylet from the lead only when satisfied with lead placement. Wireless use restrictions. Securing the lead with the lead stabilizer will mitigate this risk. The abrupt cessation of stimulation for any reason will probably cause disease symptoms to return. All patients are advised to inform their healthcare professional that they should not be exposed to diathermy treatment. If patients feel that the TENS device may be interfering with the neurostimulator, patients should discontinue using the TENS device until they talk with their physician. 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. Equipment is not serviceable by the customer. 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. Follow proper infection control procedures. Lead movement. Do not use the clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Lead movement. To prevent unintended stimulation, do not modify the operating system in any way. Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. 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. Do not crush, puncture, or burn the IPG because explosion or fire may result. Consider seeking surgical advice if you cannot easily remove a lead. Stimulation effectiveness has been established for one year. Household appliances. Always perform removal of implanted components with the patient conscious and able to give feedback. 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. Patients should also avoid any activities that would be potentially unsafe if their symptoms were to return unexpectedly. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. Sources of therapeutic radiation include therapeutic X-rays, cobalt machines, and linear accelerators. 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). If multiple leads or extensions are implanted, the leads and extensions should be routed in close proximity. communication equipment (such as microwave transmitters and high-power amateur transmitters). 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. Component manipulation. The following warnings apply to this neurostimulation system. For more information, see the clinician programmer manual. 737202011056 v5.0 | Item approved for U.S. use only. Wireless use restrictions. Use extreme care when using sharp instruments or electrosurgery devices around the lead to avoid damaging the lead. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Unlike other SCS systems, the ProclaimXR SCS system is recharge free. External defibrillators. If lithotripsy must be used, do not focus the energy near the generator. Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards. Infection. Electrosurgery. Failure to do so may result in difficulty delivering the lead. 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. PDF View Shellock R & D Services, Inc. email: . Have the patient check the device for proper functioning, even if the device was turned off. The Eterna Spinal Cord Stimulation (SCS) System is designed to deliver low-intensity electrical impulses to nerve structures. and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). Do not place TENS electrodes so that the TENS current passes over any part of the neurostimulation system. Activities requiring excessive twisting or stretching. The website that you have requested also may not be optimized for your screen size. 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. High-output ultrasonics and lithotripsy. Falling and other traumatic accidents can damage shallowly implanted components such as the leads and extensions. This neurostimulation system is contraindicated for patients who are. Read this section to gather important prescription and safety information. Pain is not resolved. Keep programmers and controllers dry. The long-term effectiveness of dorsal root ganglion (DRG) stimulation has not been documented, and not all patients realize the long-term benefits from DRG stimulation. Skydiving, skiing, or hiking in the mountains. Charge density can be reduced by lowering the stimulation amplitude or pulse width. 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.). Free from the hassles of recharging. Patients should cautiously approach such devices and should request help to bypass them. Using the tunneling tool. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target. Return all explanted IPGs to Abbott Medical for safe disposal. Less serious disadvantages of spinal cord stimulation devices include: Fluctuations in stimulation. 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. Before reinserting the sheath, verify there is no damage to the sheath. Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Use caution when securing the soft tissue anchor because damage to the anchor or lead can occur and result in failure of the system. This system is contraindicated for patients who meet the following criteria: The following procedures are contraindicated for patients with a deep brain stimulation 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. ), 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.). Keep them dry to avoid damage. The severity of any surgical complication may be greater in patients with diabetes, particularly those with inadequate pre-operative glycemic control. Diathermy therapy. Neurostimulation should not be used for patients with comorbidities that could prevent successful implant or effective therapy. Radiofrequency or microwave ablation. However, some patients may experience a decrease or increase in the perceived level of stimulation. 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. six to eight weeks after implantation of a neurostimulation system. Implanted cardiac systems. Damage to the system may not be immediately detectable. 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. Store components and their packaging where they will not come in contact with liquids of any kind. 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). 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. The long-term safety and effectiveness of this neurostimulation system has not been established beyond 5 years. INTENDED USE This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.). Lead damage from tools. NOTE: During intraoperative testing, Surgery mode must be turned off for the neurostimulation system to function correctly. The placement of the leads involves some risk, as with any surgical procedure. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. Operation of machines, equipment, and vehicles. 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. Do not crush, puncture, or burn these devices because explosion or fire may result. If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals. Note: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. Follow proper infection control procedures. 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. Consumer goods and electronic devices. Removing components. During implant procedures, if electrosurgery devices must be used, take the following actions: Complete any electrosurgery procedures before connecting the leads or extensions to the neurostimulator. Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. 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. Back pain. Security, antitheft, and radiofrequency identification (RFID) devices. 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. 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 . ); 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. 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. Patients who failed to receive effective pain relief during trial stimulation are contraindicated to process to the permanent implant procedure. If needed, return the equipment to Abbott Medical for service. Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control. 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. Before your patient undergoes an MRI scan: Confirm the MR Conditional components and location of the system. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. High stimulation outputs. 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. Poor surgical risks. Abandoned leads and replacement leads. Implanting physicians should be experienced in stereotactic and functional neurosurgery. In the case that a medical treatment is administered where an electrical current is passed through the body from an external source, first deactivate the IPG by setting all electrodes to off, turning stimulation off, and setting amplitude to zero. For less than 30 m (100 ft) of water or pressures below 4.0 ATA, durations of less than 60 minutes are recommended. Electromagnetic interference (EMI). In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted.