Patients should cautiously approach such devices and should request help to bypass them. If unpleasant sensations occur, the device should be turned off immediately. Do not use excessive pressure when injecting through the sheath. External defibrillators. Loss of coordination is a potential side effect of DBS therapy. 72188 MAT-2214515 v1.0 | Item approved for U.S. use only. Return all explanted generators to Abbott Medical for safe disposal. 72784 MAT-2215217 v2.0 | Item approved for U.S. use only. commercial electrical equipment (such as arc welders and induction furnaces). 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. If the operating field is bloody, wipe gloves, lead, stylet, and sheath before handling the lead. Our Invisible Trial System TM is a discreet, app . Remove leads slowly (at a suggested rate of 1 cm/s while holding the lead between the thumb and forefinger) to avoid breaking the lead and leaving fragments in the patient. Handle the programmers and controllers with care. Diathermy is further prohibited because it may also damage the neurostimulation system components. Keep them dry to avoid damage. If the lead extensions are routed in a loop, the loop will increase the potential for electromagnetic interference (EMI). FDA's expanded . Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. Do not place TENS electrodes so that the TENS current passes over any part of the neurostimulation system. However, advise patients who feel uncomfortable paresthesia during postural changes that they should not operate potentially dangerous equipment such as power tools, automobiles, or other motor vehicles. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. Always perform removal with the patient conscious and able to give feedback. 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. Surgical complications include, but are not limited to, the following: intracranial hemorrhage (which can lead to stroke, paralysis, or death); cerebrospinal fluid leakage or cerebrospinal fluid abnormality; persistent pain at surgery site or IPG site; brachial plexus injury (nerves to chest, shoulder and arm); postoperative pain, stress, or discomfort; hemiparesis (muscular weakness or partial paralysis on one side of body); ballism or hemiballism (uncontrollable movements on both or only one side of the body); confusiontransient, nocturnal or ongoing; cognitive impairment, including delirium, dementia, disorientation, psychosis and speech difficulties; pulmonary embolism (sudden blood vessel obstruction); aborted procedures (air embolism, unable to find target, surgical complication, etc. Confirm that the neurostimulation system is functioning correctly during the implant procedure, before closing the neurostimulator pocket, and after the implant procedure. Low frequencies. Safety and effectiveness of neurostimulation for pediatric use have not been established. Approved models and implant locations for an MR Conditional full system, *The IPG port plug associated with these models is also an MR Conditional component. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. Generator disposal. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (if either occurs, turn off your IPG immediately. Sheath insertion precaution. Use extreme care to not damage the lead with the sharp point of the tunneling tool. Skydiving, skiing, or hiking in the mountains. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. Proclaim XR SCS System Meaningful relief from chronic pain. 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. Clinician programmers, patient controllers, and chargers are not waterproof. Conversely, the other active implanted device may interfere with the operation of the neurostimulation system. Patient's visual ability to read the patient controller screen. Before reinserting the sheath, verify there is no damage to the sheath. Patients should not operate potentially dangerous machinery, power tools, or vehicles or engage in any activity that could be unsafe if their symptoms were to unexpectedly return. Care and handling of components. 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. The equipment is not serviceable by the customer. All patients are advised to inform their healthcare professional that they should not be exposed to diathermy treatment. 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. For more information about MR Conditional deep brain stimulation (DBS) 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 DBS systems(available online atmedical.abbott/manuals). Do not implant a device if the sterile package, the device, or any device components show signs of damage, tampering, or if the sterile seal is ruptured, or contamination is suspected for any reason. Security, antitheft, and radiofrequency identification (RFID) devices. Infections related to system implantation might require that the device be explanted. and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). Lead movement. 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. Before your patient undergoes an MRI scan: Confirm the MR Conditional components and location of the system. Device profile of the Proclaim XR neurostimulation system for the Object Info: - MRI Safety If the implanted system contains components or models not listed in the followingtable, then the system is considered MR Unsafe. Overcommunicating with the IPG. MRI Support | Abbott A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Do not use the clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. 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. Failure to do so may result in damage to the sheath. If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals. Getting an MRI | Medtronic 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. It's small, discreet and available with Abbott's proprietary BurstDR stimulation, a new technology that's clinically proven to . The operation of the clinician programmer or patient controller could cause them to ignite, causing severe burns, injury, or death. Always be aware of the needle tip position. 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. Patients should not use this neurostimulation system if they are pregnant or nursing. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. 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. 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. Expected effect from cessation of therapy, should disease symptoms return unexpectedly. 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. Storage environment. Failure to provide strain relief may result in lead migration requiring a revision procedure. This damage could result in loss of therapy, requiring additional surgery for system replacement. ** This neurostimulation system is indicated for spinal column stimulation via epidural and intraspinal lead access to the dorsal root ganglion as an aid in the management of moderate to severe chronic intractable* pain of the lower limbs in adult patients with complex regional pain syndrome (CRPS) types I and II.**. Clinician training. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. Less serious disadvantages of spinal cord stimulation devices include: Fluctuations in stimulation. If the programming of stimulation parameters exceeds the charge density limit of 30 C/cm2, a screen will appear warning you that the charge density is too high. Operation of machines, equipment, and vehicles. Maximize the distance between the implanted systems (minimum separation distance of approximately 8 cm (3 in.) Consider bipolar programming of both devices and use neurostimulation system settings that do not interfere with the function of the implantable cardiac system. Household appliances. 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. IPGs contain batteries as well as other potentially hazardous materials. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Radiofrequency or microwave ablation. 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. Electromagnetic interference (EMI). 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. 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. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. Therefore, physicians should consider the following: Preoperatively, assess patients for the risks of depression and suicide. Patients should be advised to avoid carrying mobile phones in their shirt pocket or otherwise placing them directly over the deep brain stimulation system components. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. The safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established. 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. Physicians should also discuss any risks of MRI with patients. Wireless use restrictions. between lead ends is recommended); Verify that the neurostimulation system is not interfering with the function of the implanted cardiac system; and. If needed, return the equipment to Abbott Medical for service. 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. Neuromodulation | For Consumers | Abbott U.S. The device should be turned off and the doctor contacted if this occurs. Scuba diving or hyperbaric chambers. Do not suture directly onto the lead to avoid damaging the lead. If a system does not meet the MR Conditional requirements, consider it MR Unsafe. 74372 MAT-2215216 v3.0 | Item approved for U.S. use only. To prevent injury or damage to the system, do not modify the equipment. Computed tomography (CT). 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. System testing. Application modification. Number of leads implanted. **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. Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. 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. Operation of machinery and equipment. 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. Interference with other devices. Proclaim Plus: The Next Burst in Chronic Pain Care | Abbott Newsroom Implanted cardiac systems. If radiation therapy is required, the area over the implanted generator should be shielded with lead. Inaccurate ECG results may lead to inappropriate treatment of the patient. Programmer use. Patient activities and environmental precautions. Handle the device with care. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. 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. 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. We offer products that are MR Conditional for spinal cord stimulation (SCS) and dorsal root ganglion (DRG) therapy. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. High stimulation outputs. Unauthorized changes to stimulation parameters. Electrocardiograms. FDA approves new MRI compatibility for Abbott's Proclaim spinal cord 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. Emergency procedures. Follow proper infection control procedures. Safety has not been established for TMS or ECT in patients who have an implanted neurostimulation system. The system can be programmed to use parameter settings outside the range of those used in the clinical studies. Patients should not be dependent on drugs and should be able to operate the neurostimulation system. While charging the generator, patients may perceive an increase in temperature at the generator site. Follow proper infection control procedures. Other neurostimulators may restrict the allowed MRI power or scan location, preventing imaging on your shoulders or vital organs in your torso. Exposure to body fluids or saline. See Full System Components below if the patient has an IPG and extensions implanted. 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. The neurostimulator is controlled by a trained operator and the starting point for the stimulation will be set to the lowest available settings. Component handling. Patients should take reasonable care to avoid devices that generate strong EMI, which may cause the neurostimulation system to unintentionally turn on or off. Component disposal. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. When inserting the lead-sheath assembly through the needle into the epidural space, tighten the lead stabilizer to prevent lead migration out of the sheath.