If unpleasant sensations occur, the device should be turned off immediately using the patient magnet. Package or component damage. Do not bend, kink, or use surgical instruments on the stylet, as this may damage it. Learn more about the scan details for our MR Conditional products below. IPG disposal. 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. Both the Intellis and Vanta SCS devices integrate SureScan MRI technology, providing MRI access anywhere in the body with normal operating mode power settings. Single-use, sterile device. Return all explanted components to Abbott Medical for safe disposal. If a patient experiences new or worsening depression or suicidal ideation, manage these symptoms appropriately. 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. 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. Therapeutic radiation. Wireless use restrictions. For more information, see the clinician programmer manual. 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. The system can be programmed to use parameter settings outside the range of those used in the clinical studies. Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation. Keep them dry to avoid damage. Lead insertion through sheath. Remove leads slowly. Do not crush, puncture, or burn the IPG because explosion or fire may result. Poor surgical risks. Sudden loss of stimulation may cause patients to fall or lose control of equipment or vehicles, injure others, or bring injury upon themselves. Scuba diving or hyperbaric chambers. 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. 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. If interference occurs, try holding the phone to the other ear or turning off the phone. PDF View Shellock R & D Services, Inc. email: . Operation of machines, equipment, and vehicles. To prevent unintended stimulation, do not modify the operating system in any way. Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. 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. 74372 MAT-2215216 v3.0 | Item approved for U.S. use only. Electrocardiograms. Advise patients to not use their device when engaging in activities that might cause it to get wet, such as swimming or bathing. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. Component handling. Confirm implant locations and scan requirements for the patients system. Handle the device with care. Patients should cautiously approach such devices and should request help to bypass them. Device components. Thorough psychiatric screening should be performed. Securing the IPG. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have 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. 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. If the patient requires a CT scan, all stimulation should be turned off before the procedure. External defibrillators. INTENDED USE This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. 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. Always perform removal of implanted components with the patient conscious and able to give feedback. Skydiving, skiing, or hiking in the mountains. Abandoned leads and replacement leads. Pediatric use. If the lead is unable to deploy out of the sheath, inject sterile water or saline slowly to release tissue that may have entered between the sheath and the lead. Use caution when sedating the patient. Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket. Nerve damage may result from traumatic or surgical nerve injury. 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. Abbott's Prodigy, Proclaim, and Proclaim XR SCS Systems are used to help manage chronic, intractable pain of the trunk and/or limbs, including one-sided or two-sided pain associated with the . After defibrillation, confirm the neurostimulation system is still working. Stimulation Modes. Patients should take reasonable care to avoid devices that generate strong EMI, which may cause the neurostimulation system to unintentionally turn on or off. 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. 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. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. This system is contraindicated for patients who meet the following criteria: The following procedures are contraindicated for patients with a deep brain stimulation system. Case damage. Have the patient check the device for proper functioning, even if the device was turned off. The following precautions apply to this neurostimulation system. Safety and effectiveness of neurostimulation for pediatric use have not been established. Unwanted changes in stimulation may include a jolting or shocking feeling. Operating the device near gas fumes or vapors could cause them to catch fire. INDICATIONS FOR USE 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. Clinician programmers, patient controllers, and chargers are not waterproof. Using surgical instruments. Storage environment. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. Our Invisible Trial System TM is a discreet, app . Pregnancy and nursing. Physicians should also discuss any risks of MRI with patients. Keep programmers and controllers dry. 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. Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the neurostimulation system. Product materials. An expiration date (or use-before date) is printed on the packaging. Therapeutic magnets. Electrical medical treatment. Case damage. 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. Schu S, Gulve A, ElDabe S, et al. The neurostimulator is controlled by a trained operator and the starting point for the stimulation will be set to the lowest available settings. 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. 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. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system: Other active implanted devices. External defibrillation can cause induced currents in the leadextension portion of the neurostimulation system. 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). 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. 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. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. Surgeon training. The Eterna Spinal Cord Stimulation (SCS) System is designed to deliver low-intensity electrical impulses to nerve structures. If gas fumes or vapors catch fire, it could cause severe burns, injury, or death. Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible. Case damage. For complete MRI guidance, parameters and cautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. Programmer and controller devices are not waterproof. 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. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. Household appliances that contain magnets (e.g., refrigerators, freezers, inductive cooktops, stereo speakers, mobile telephones, cordless telephones, standard wired telephones, AM/FM radios, and some power tools) may unintentionally cause the neurostimulation system to turn on or turn off. Generator disposal. ABBOTT PARK, Ill., Jan. 26, 2023 /PRNewswire/ -- Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has approved its Proclaim XR spinal cord stimulation (SCS) system to treat painful diabetic peripheral neuropathy (DPN), a debilitating complication of diabetes. 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. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. 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. Keep the device dry. Cremation. Infections related to system implantation might require that the device be explanted. During the implant procedure, if an electrosurgery device must be used, take the following actions:. 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. Advise patients to inform their healthcare professional that they should not be exposed to diathermy treatment. Lead movement. 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. 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. Pregnancy and nursing. 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. Falling and other traumatic accidents can damage shallowly implanted components such as the leads and extensions. Approved models and implant locations for an MR Conditional lead-only system. Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinsons disease. In rare cases, this can create a medical emergency. 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. Always perform removal with the patient conscious and able to give feedback. This damage could result in loss of therapy, requiring additional surgery for system replacement. Safety has not been established for TMS or ECT in patients who have an implanted neurostimulation system. Detailed information on storage environment is provided in the appendix of this manual. Device modification. Bending the sheath. Jude, Medtronic).Most of the early models of these devices were considered MR Unsafe primarily due to the theoretical risk of spinal cord injury from heating of the the electrode tip by RF-induced currents (the so-called antenna effect). For CT procedures in which the medical device is in or immediately adjacent to the programmed scan range, the operator should: If practical, try to move external devices out of the scan range. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. 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. The following warnings apply to this neurostimulation system. Less serious disadvantages of spinal cord stimulation devices include: Fluctuations in stimulation. Patients should be advised to not use therapeutic magnets. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. For complete guidance, directions, and cautions on MRI safety with a specific device,please review the MRI procedure clinician's manual. 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. The equipment is not serviceable by the customer. Implantation of multiple leads. For complete and comprehensive MRI support, parameters, and precautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. Use extreme care when handling system components. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. Care and handling of components. All patients are advised to inform their healthcare professional that they should not be exposed to diathermy treatment. 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. Consumer goods and electronic devices. Mobile phones. Failure to do so may cause harm to the patient such as damage to the dura. The long-term safety associated with multiple implants, leads left in place without use, replacement of leads, multiple implants into the target structure, and lead explant is unknown. Do not use the application if the operating system is compromised (i.e., jailbroken). Failure to do so may result in difficulty delivering the lead. Electrosurgery. 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. In some cases, symptoms may return with a greater intensity than what a patient experienced before system implantation (rebound effect). All components listed must be implanted unless noted as "optional." At the core of this patient-centric advancement is a battery that can last up to 10 years at low-dose settings** without the hassles of recharging. This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. Lead inspection. Patients should exercise reasonable caution when bathing. 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. Patient selection. NOTE: During intraoperative testing, Surgery mode must be turned off for the neurostimulation system to function correctly. When multiple leads are implanted, route the lead extensions so the area between them is minimized. Security, antitheft, and radiofrequency identification (RFID) devices. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Explosive and flammable gasses. 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. Scuba diving or hyperbaric chambers. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) Patients should cautiously approach such devices and should request help to bypass them. 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, which are implanted, electrically insulated wires that transmit electrical impulses to the target nerves Transcutaneous electrical nerve stimulation (TENS). For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. The long-term safety and effectiveness of this neurostimulation system has not been established beyond 5 years. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. Up to two IPGs, leads, extensions, and burr hole covers may be implanted. Diathermy therapy. Operation of machinery and equipment. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Diathermy is further prohibited because it may also damage the neurostimulation system components. IPGs contain batteries as well as other potentially hazardous materials. Security, antitheft, and radiofrequency identification (RFID) devices. Use appropriate sterile technique when implanting leads and the IPG. 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). Lead handling. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. To correct the effects of typical interference, keep wireless communication equipment at least 15 cm (6 in) from the IPG. Proclaim Plus Spinal Column Stimulation (SCS) System PRESCRIPTION AND SAFETY INFORMATION Read this section to gather important prescription and safety information. High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. 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. Always be aware of the needle tip position. The U.S. Food and Drug Administration (FDA) approved Abbott's Eterna spinal cord stimulation (SCS) system for the treatment of chronic pain This neuromodulation device provides an optimized experience with the ability to wirelessly charge as few as five times per year, the lowest recharge burden compared to other rechargeable SCS systems 1,2,3 Infection. Do not resterilize or reimplant an explanted system for any reason. The severity of any surgical complication may be greater in patients with diabetes, particularly those with inadequate pre-operative glycemic control. Removing each item in slow movements while holding the remaining components in place will assist this process. Deep brain stimulation complications include, but are not limited to, the following: Undesirable changes in stimulation related to cellular changes in tissue around the electrodes, changes in the electrode position, loose electrical connections, or lead fracture, Loss of therapeutic benefit as a result of change in electrode positions, loose electrical connections, or lead or extension fracture, Initial jolt or tingling during stimulation; jolting or shocking sensations, Lead fracture, migration, or dislodgement, Extension malfunction, fracture, or disconnect, Deep brain stimulation system failure or battery failure within the device, Deep brain stimulation system malfunction or dislodgement, Allergic or rejection response to implanted materials, Persistent pain, tightness, or redness at the incision sites or general pain, General erosion or local skin erosion over the IPG, Persistent pain, tightness, or discomfort around the implanted parts (e.g., along the extension path in the neck), Impaired wound healing (e.g., incision site drainage) or abscess formation, Additional neurosurgical procedure to manage one of the above complications or to replace a malfunctioning component, Stimulation-related complications or other complications, Worsening of motor impairment and Parkinsons disease symptoms including dyskinesia, rigidity, akinesia or bradykinesia, myoclonus, motor fluctuations, abnormal gait or incoordination, ataxia, tremor, and dysphasia, Paresis, asthenia, hemiplegia, or hemiparesis, Sensory disturbance or impairment including neuropathy, neuralgia, sensory deficit, headache, and hearing and visual disturbance, Speech or language impairment including, aphasia, dysphagia, dysarthria, and hypophonia, Cognitive impairment including attention deficit, confusion, disorientation, abnormal thinking, hallucinations, amnesia, delusions, dementia, inability to act or make decisions, psychic akinesia, long term memory impairment, psychiatric disturbances, depression, irritability or fatigue, mania or hypomania, psychosis, aggression, emotional lability, sleep disturbance, anxiety, apathy, drowsiness, alteration of mentation, postural instability and disequilibrium, Cardiac dysfunction (e.g., hypotension, heart rate changes, or syncope), Eye disorder including eye apraxia or blepharospasm, (1) The symbol statement Rx only or only or the statement Caution: Federal law restricts this device to sale by or on the order of a ___, the blank to be filled with the word physician, dentist, veterinarian, or with the descriptive designation of any other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device; and. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. However, some patients may experience a decrease or increase in the perceived level of stimulation. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator.

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