Up to two IPGs, leads, extensions, and burr hole covers may be implanted. If the lead extensions are routed in a loop, the loop will increase the potential for electromagnetic interference (EMI). Do not use the clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. If the patient requires a CT scan, all stimulation should be turned off before the procedure. INTENDED USE This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Needle positioning. Case damage. This includes oxygen-enriched environments such as hyperbaric chambers. 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. Therapeutic radiation. Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinsons disease. Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. Set the electrosurgery device to the lowest possible energy setting. Electromagnetic interference (EMI). This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. 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. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott. Pregnancy and nursing. 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. Proclaim XR SCS System Meaningful relief from chronic pain. Patients will receive an identification card to carry with them that will inform emergency medical personnel of their implanted system. Devices with one-hour recharge per day. Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. 71376 MAT-2006974 v2.0 | Item approved for U.S. use only. Return the explanted IPG to Abbott Medical. 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. **Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia as complex regional pain syndrome (CRPS) types I and II, respectively. Storage environment. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. Diathermy therapy. To correct the effects of typical interference, keep wireless communication equipment at least 15 cm (6 in) from the IPG. In some cases, symptoms may return with a greater intensity than what a patient experienced before system implantation (rebound effect). Unlike other SCS systems, the ProclaimXR SCS system is recharge free. Security, antitheft, and radiofrequency identification (RFID) devices. Magnetic resonance imaging (MRI). 72784 MAT-2215217 v2.0 | Item approved for U.S. use only. During the implant procedure, if an electrosurgery device must be used, take the following actions:. Return them to Abbott Medical for proper disposal. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. Patients should not be dependent on drugs and should be able to operate the neurostimulation system. If unpleasant sensations occur, the device should be turned off immediately using the patient magnet. Security, antitheft, and radiofrequency identification (RFID) devices. Battery care. 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. 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. The tip of the sheath may whip around and could cause harm to the patient. Wireless use restrictions. 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. Safety has not been established for TMS or ECT in patients who have an implanted neurostimulation system. 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. Patients who failed to receive effective pain relief during trial stimulation are contraindicated to process to the permanent implant procedure. Remove the stylet from the lead only when satisfied with lead placement. Keep programmers and controllers dry. Make the Bold Choice 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). 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. If the neurostimulator is on during an ECG, the ECG recording may be adversely affected, resulting in inaccurate ECG results. Battery precaution. Sheath rotation. Wireless use restrictions. To prevent unintended stimulation, do not modify the operating system in any way. Failure to do so can damage or cut the lead or sheath. Maximize the distance between the implanted systems (minimum separation distance of approximately 8 cm (3 in.) If the stylet is removed from the lead, it may be difficult to reinsert it. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems (available online at medical.abbott/manuals). Radiofrequency or microwave ablation. Transcutaneous electrical nerve stimulation (TENS). External defibrillation can cause induced currents in the lead-extension portion of the neurostimulation system. Use caution when positioning the needle to avoid unintended injury to surrounding anatomical structures. Always be aware of the needle tip position. 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. If multiple leads or extensions are implanted, the leads and extensions should be routed in close proximity. Household appliances. 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. Set the electrosurgery device to the lowest possible energy setting. Patients should not dive below 30 m (100 ft) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). If needed, return the equipment to Abbott Medical for service. Surgical complications and adverse events may be more frequent and severe in patients with diabetes. Loss of coordination is a potential side effect of DBS therapy. The system can be programmed to use parameter settings outside the range of those used in the clinical studies. Therefore, physicians should consider the following: Preoperatively, assess patients for the risks of depression and suicide. 72750 MAT-2215018 v2.0 | Item approved for U.S. use only. 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. 71409MAT-2116350 v4.0 | Item approved for U.S. use only. Confirm that the neurostimulation system is functioning correctly during the implant procedure, before closing the neurostimulator pocket, and after the implant procedure. 21 CR 801.109(b) The label of the device, other than surgical instruments, bears: (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. Operation of machines, equipment, and vehicles. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. See Full System Components below if the patient has an IPG and extensions implanted. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.). Lead inspection. 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. 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. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or render the patient incapable of controlling the generator. Introduction: Spinal cord stimulation is becoming an increasingly used modality for the treatment of chronic pain. Clinician training. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. Return all explanted IPGs to Abbott Medical for safe disposal. Higher amplitudes and wider pulse widths may indicate a system problem or a suboptimal lead placement. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems. 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 . Clinician training. Do not crush, puncture, or burn these devices because explosion or fire may result. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. Up to two leads, lead protection boots, and burr hole covers may be implanted. Implantation of this neurostimulation system is contraindicated for the following: Patients for whom test stimulation is unsuccessful. 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. Scanning under different conditions may cause device malfunction, severe patient injury, or death. Component manipulation by patients. Component disposal. Poor surgical risks. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. Operating the device near gas fumes or vapors could cause them to catch fire. six to eight weeks after implantation of a neurostimulation system. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. The IPG should be explanted before cremation because the IPG could explode. Placing the IPG. Recharge-by date. Energy from diathermy can be transferred through the implanted system and can cause tissue damage at the location of the implanted electrodes, resulting in a severe injury or death. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. Poor surgical risks. Surgeon training. Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. However, current data shows that most patients using BurstDR stimulation therapy do not experience paresthesia. 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. To prevent unintended stimulation, do not modify the generator software in any way. 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. 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. INDICATIONS FOR USE Skydiving, skiing, or hiking in the mountains. If the sheath has been kinked during delivery, slowly retract through the needle with the curve facing the same direction as the bevel. High altitudes should not affect the neurostimulator; however, the patient should consider the movements involved in any planned activity and take precautions to avoid putting undue stress on the implanted system. 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. Stimulation frequencies at less than 30 Hz may cause tremor to be driven (meaning that tremor occurs at the same frequency as the programmed frequency). Our Invisible Trial System TM is a discreet, app . 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.