Stimulation effectiveness has been established for one year. Read this section to gather important prescription and safety information. For this reason, programming at frequencies less than 30 Hz is not recommended. Implantation of two systems. 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. 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. January 4, 2022 By Sean Whooley. 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. Return any suspect components to Abbott Medical for evaluation. This equipment is not serviceable by the customer. Electrical medical treatment. Abbott (NYSE:ABT) announced today that it received FDA approval for new magnetic resonance imaging (MRI) compatibility for the Proclaim system. External defibrillation can cause induced currents in the leadextension portion of the neurostimulation system. Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. 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. 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. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief 1. Back pain. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. Do not resterilize or reimplant an explanted system for any reason. Infection. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. The tip of the sheath may whip around and could cause harm to the patient. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. Pediatric use. Removing components. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. Case damage. Always perform removal with the patient conscious and able to give feedback. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. 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. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. Ask patients with neurostimulators to shut off the device temporarily while the scan is performed. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. Before opening any sterile package, verify the kit model number, that the kit is within its expiration (use-before) date, and that the packaging has not been damaged or compromised in any way. Use extreme care to not damage the lead with the sharp point of the tunneling tool. For complete MRI guidance, parameters and cautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. Patient training. Abbott recently received new FDA-approved labeling which expands MRI compatibility with the leads used on the Proclaim TM XR Spinal Cord Stimulation System. If multiple leads or extensions are implanted, the leads and extensions should be routed in close proximity. Electromagnetic interference (EMI). The following additional considerations should be made for patients with diabetes: A pre-operative risk assessment should be performed for patients with diabetes who are at high risk for ischemic heart disease, those with autonomic neuropathy or renal failure, and patients with a Hemoglobin A1C (HbA1c) 8% (64 mmol/mol). This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Patients will receive an identification card to carry with them that will inform emergency medical personnel of their 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. Therapeutic radiation. Interference with other devices. Exposure to body fluids or saline. The system is intended to be used with leads and associated extensions that are compatible with the system. 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. Patient selection. Higher amplitudes and wider pulse widths may indicate a system problem or a suboptimal lead placement. 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. Falling and other traumatic accidents can damage shallowly implanted components such as the leads and extensions. During the 2000s about a dozen companies sold and manufactured SCS systems worldwide, including the "big three" (Boston Scientific, Abbott/St. maximize the distance between the implanted systems; Use in patients with diabetes. Needle insertion. In addition, a component must be implanted in its approved location as listed in the following table or the entire implanted system is considered MRUnsafe. The Prodigy MRI SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott's smallest implantable pulse generator (IPG). 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. Anchoring leads. 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. Note: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. Infections related to system implantation might require that the device be explanted. 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. Advance the needle and guidewire slowly. 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. Unauthorized changes to stimulation parameters. Detailed information on storage environment is provided in the appendix of this manual. Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinsons disease. 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. six to eight weeks after implantation of a neurostimulation system. Programmer and controller devices are not waterproof. Lead movement. Implanting physicians or anesthesiologists should consult practice guidelines for the intraoperative management of patients with diabetes. Output power below 80 W is recommended for all activations. Handle the programmers and controllers with care. Surgeon training. Advise patients to inform their healthcare professional that they should not be exposed to diathermy treatment. Advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan. Neurostimulation should not be used for patients with comorbidities that could prevent successful implant or effective therapy. Thorough psychiatric screening should be performed. 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. Safety has not been established for radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system. 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. Confirm the neurostimulation system is functioning. Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system. Use care when reinserting a stylet. 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. Only apply software updates that are published directly by Abbott Medical. 74373 MAT-2300644 v2.0 | Item approved for U.S. use only. 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. Read this section to gather important prescription and safety information. 737202011056 v5.0 | Item approved for U.S. use only. Electromagnetic interference (EMI). Return any suspect components to Abbott Medical for evaluation. Perception of higher levels of stimulation has been described by some patients as uncomfortable, painful, or jolting. Exit Surgery mode during intraoperative testing and after the procedure is completed. The Eterna SCS 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 and intractable low back and leg pain. 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. Preventing infection. Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. Stabilizing the lead during insertion. If the implanted system contains any other components or models than what appears in the following tables, then the system is considered untested for an MRI environment. The force of the instruments may damage the lead or stylet. IPG disposal. Advise patients about adverse effects. The safety and efficacy of the implantation of greater than four leads have not been evaluated. Restricted areas. Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. Case damage. Consider bipolar programming of both devices and use neurostimulation system settings that do not interfere with the function of the implantable cardiac system. Clinician training. 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. 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). Batteries can explode, leak, or melt if disassembled, shorted (when battery connections contact metal), or exposed to high temperature or fire. 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. Poor surgical risks. Patients should avoid charging their generator over an incision that has not completely healed. 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. The needle will be inserted at a steeper angle than in an antegrade approach and there is a greater chance of dural puncture that will lead to a cerebrospinal fluid leak. Consumer goods and electronic devices. Generator disposal. See Full System Components below if the patient has an IPG and extensions implanted. Securing the anchor. Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. 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. Return the explanted IPG to Abbott Medical. Physicians should also discuss any risks of MRI with patients. Care and handling of components. 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. 72784 MAT-2215217 v2.0 | Item approved for U.S. use only. In rare cases, this can create a medical emergency. 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. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Stimulation Modes. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. 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. 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. Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards. 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. 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. Pregnancy and nursing. Patients who are unable to properly operate the system. 72184 MAT-2214513 v1.0 | Item approved for U.S. use only. Failure to do so may result in difficulty delivering the lead. Low frequencies. Use caution when securing the soft tissue anchor because damage to the anchor or lead can occur and result in failure of the system. Equipment is not serviceable by the customer. Control of the patient controller. This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. Conscious sedation. Component disposal. Lead movement. 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. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. Conditional 5. 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. If multiple leads are implanted, leads and extensions should be routed in close proximity. All components listed must be implanted unless noted as "optional." 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. Lead insertion through sheath. This includes oxygen-enriched environments such as hyperbaric chambers. IPGs contain batteries as well as other potentially hazardous materials. Pregnancy and nursing. If unpleasant sensations occur, the device should be turned off immediately. Return any suspect components to Abbott Medical for evaluation. The system is intended to be used with leads and associated extensions that are compatible with the system. If lithotripsy must be used, do not focus the energy near the generator. 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. In patients who have areas of increased sensitivity to heat, consider placing the implant where the patient has normal sensation. 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. Patients should cautiously approach such devices and should request help to bypass them. Spinal cord stimulation of the dorsal root ganglion for groin pain-a retrospective review. Abandoned leads and replacement leads. 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. Make the Bold Choice 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. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). 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. Infection. 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. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. 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. Stylet handling. 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. Patient activities and environmental precautions. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.). However, current data shows that most patients using BurstDR stimulation therapy do not experience paresthesia. 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.