In patients who have areas of increased sensitivity to heat, consider placing the implant where the patient has normal sensation. Read this section to gather important prescription and safety information. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. 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. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. Read this section to gather important prescription and safety information. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient controller. This includes oxygen-enriched environments such as hyperbaric chambers. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. The system is intended to be used with leads and associated extensions that are compatible with the system. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or render the patient incapable of controlling the generator. 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. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Place the neurostimulator in Surgery mode before using an electrosurgery device. Do not use the application if the operating system is compromised (i.e., jailbroken). separates the implanted generators to minimize unintended interaction with other system components. 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). 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. 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. External defibrillation can cause induced currents in the leadextension portion of the neurostimulation system. Implantation of two systems. Failure to do so may cause harm to the patient such as damage to the dura. If needed, return the equipment to Abbott Medical for service. For specific indications, contraindications, instructions, warnings, precautions, and adverse effects about system components available in your country or region, see the approved clinician's manual for those components. If lithotripsy must be used, do not focus the energy near the IPG. Electrical medical treatment. Instruct patients to use their neurostimulation system only after an authorized clinician has programmed the generator and has trained the patient on how to safely control stimulation and to charge the system. Proclaim XR SCS System Meaningful relief from chronic pain. Thorough psychiatric screening should be performed. Scuba diving and hyperbaric chambers. Up to two IPGs, leads, extensions, and burr hole covers may be implanted. Complete any electrosurgery before connecting the leads or extensions to the neurostimulator. Package or component damage. This damage could result in loss of therapy, requiring additional surgery for system replacement. The neurostimulator is controlled by a trained operator and the starting point for the stimulation will be set to the lowest available settings. Conversely, the other active implanted device may interfere with the operation of the neurostimulation system. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. 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. Follow proper infection control procedures. 74373 MAT-2300644 v2.0 | Item approved for U.S. use only. Return any suspect components to Abbott Medical for evaluation. If two systems are implanted, ensure that at least 20 cm (8 in.) Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation. 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. Do not resterilize or reimplant an explanted system for any reason. 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. Explosive and flammable gasses. If unpleasant sensations occur, the device should be turned off immediately using the patient magnet. 71409MAT-2116350 v4.0 | Item approved for U.S. use only. 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. The system is intended to be used with leads and associated extensions that are compatible with the system. Advise your patient to avoid manipulating the implanted system components (e.g., the neurostimulator, the burr hole site). 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. Failure to provide strain relief may result in lead migration requiring a revision procedure. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. 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. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Electrocardiograms. An expiration date (or use-before date) is printed on the packaging. 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. If they must go through or near a gate or doorway containing this type of device, patients should move quickly and then check their IPG to determine if it is turned on or off. Infection. 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. Securing the IPG. Stabilizing the lead during insertion. Devices with one-hour recharge per day. Needle positioning. Unlike other SCS systems, the Proclaim XR SCS system is recharge free. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. Conditional 5. Implantation of multiple leads. Do not crush, puncture, or burn these devices because explosion or fire may result. Patients should not dive below 30 m (100 ft) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). The placement of the leads involves some risk, as with any surgical procedure. If the implanted system contains components or models not listed in the followingtable, then the system is considered MR Unsafe. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the location of the implanted electrodes, resulting in severe injury or death. 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. If this date has been reached or has been exceeded before the date of implantation, the generator should be charged prior to implantation. 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. 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. Do not over-manipulate the sheath and lead system as this may result in trauma within the epidural space. For patients who do not feel paresthesia, sudden stimulation changes are less likely to occur and distract them while operating motorized vehicles, machinery, or equipment. After defibrillation, confirm the neurostimulation system is still working. To prevent unintended stimulation, do not modify the operating system in any way. Suicidal ideation, suicide attempts, and suicide are events that have also been reported. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. Lead handling. Other active implantable devices. Additional Disadvantages. Implanted cardiac systems. 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. Patient activities and environmental precautions. Surgical complications and adverse events may be more frequent and severe in patients with diabetes. Magnetic resonance imaging (MRI). 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). ** Conscious sedation during removal. Operation of machines, equipment, and vehicles. 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. The abrupt cessation of stimulation for any reason will probably cause disease symptoms to return. Always perform removal of implanted components with the patient conscious and able to give feedback. Abbott recently received new FDA-approved labeling which expands MRI compatibility with the leads used on the Proclaim TM XR Spinal Cord Stimulation System. The following procedures are contraindicated for patients that have been implanted with this device: Diathermy therapy. Radiofrequency or microwave ablation. Removing each item in slow movements while holding the remaining components in place will assist this process. Inserting the anchor. 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, kink, or use surgical instruments on the stylet, as this may damage it. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. Implant heating. Physicians should also discuss any risks of MRI with patients. Component disposal. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Ensure the patients neurostimulation system is in MRI mode. Consider seeking surgical advice if you cannot easily remove a lead. Remove the stylet from the lead only when satisfied with lead placement. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). The operation of the clinician programmer or patient controller could cause them to ignite, causing severe burns, injury, or death. In some cases, symptoms may return with a greater intensity than what a patient experienced before system implantation (rebound effect). Lead inspection. Sheath retraction. 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 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. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. Coagulopathies. Falling and other traumatic accidents can damage shallowly implanted components such as the leads and extensions. Keep them dry to avoid damage. A multicenter, prospective trial to assess the safety and performance of the spinal modulation dorsal root ganglion neurostimulator system in the treatment of chronic pain. separates the implanted IPGs to minimize unintended interaction with other system components. Sheath insertion warning. 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. 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. 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. Maximize the distance between the implanted systems (minimum separation distance of approximately 8 cm (3 in.) Case damage. 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. 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. Infection. Patients should take reasonable care to avoid devices that generate strong EMI, which may cause the neurostimulation system to unintentionally turn on or off. Loss of coordination is a potential side effect of DBS therapy. Magnetic resonance imaging (MRI). Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the management of disabling tremor. Lead insertion through sheath. 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. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. The Eterna Spinal Cord Stimulation (SCS) System is designed to deliver low-intensity electrical impulses to nerve structures. Inaccurate ECG results may lead to inappropriate treatment of the patient. Electromagnetic interference (EMI). Cremation. A recharge-by date is printed on the packaging. Postural changes. 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. The BurstDR stimulation mode has not been evaluated for effectiveness in the diabetic peripheral neuropathy (DPN) population. 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). Return them to Abbott Medical for proper disposal. 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. 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). Advise patients to inform their healthcare professional that they should not be exposed to diathermy treatment. If lithotripsy must be used, do not focus the energy near the generator. Batteries can explode, leak, or melt if disassembled, shorted (when battery connections contact metal), or exposed to high temperature or fire. 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. Free from the hassles of recharging. (2) The method of its application or use. The IPG should be placed into the pocket, at a depth not to exceed 4.0 cm (1.57 in), with the logo side facing toward the skin surface. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Computed tomography (CT). 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. 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). This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. For this reason, programming at frequencies less than 30 Hz is not recommended. 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. 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. Changes in blood glucose levels in response to any adverse effect 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. 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,. 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. If the sheath needs to be retracted from the epidural space, verify that the steering wing is rotated away from the needle mark no more than 90 degrees. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. If unpleasant sensations occur, turn off stimulation immediately. Multiple leads. The safety and effectiveness of neurostimulation for pediatric use have not been established. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Security, antitheft, and radiofrequency identification (RFID) devices. Lasting Relief through our smallest system yet. 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. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician.