Infection. away from the generator and avoid placing any smart device in a pocket near the generator. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. 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. Battery precaution. Have the patient check the device for proper functioning, even if the device was turned off. Component handling. Lead inspection. If this date has been reached or has been exceeded before the date of implantation, the generator should be charged prior to implantation. In patients who have areas of increased sensitivity to heat, consider placing the implant where the patient has normal sensation. To prevent injury or damage to the system, do not modify the equipment. 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. 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. Abbott Launches the World's Smallest Implantable, Rechargeable Spinal Control of the patient controller. The following precautions apply to this neurostimulation system. Electrical medical treatment. Do not use the system if the use-before date has expired. Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. Unlike other SCS systems, the Proclaim XR SCS system is recharge free. Household appliances. Implant heating. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. All components listed must be implanted unless noted as "optional." Caution patients to not make unauthorized changes to physician-established stimulation parameters. Careful consideration should be used before using radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system since safety has not been established. Return the explanted IPG to Abbott Medical. Insertion of a sheath without the lead may result in dural puncture. During the implant procedure, if an electrosurgery device must be used, take the following actions:. The website that you have requested also may not be optimized for your screen size. January 4, 2022 By Sean Whooley. The clinician programmer and patient controller are not waterproof. If needed, return the equipment to Abbott Medical for service. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. 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. Failure to provide strain relief may result in lead migration requiring a revision procedure. Interference with wireless equipment. 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 force of the instruments may damage the lead or stylet. 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. Use extreme care when removing the lead stylet, the delivery sheath, and the needle to ensure that the distal tip of the lead remains in the desired location. 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. The following procedures are contraindicated for patients that have been implanted with this device: Diathermy therapy. 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 the patient requires a CT scan, all stimulation should be turned off before the procedure. 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. Ensure the neurostimulator is off before initiating an electrocardiogram (ECG). Free from the hassles of recharging. MRI SUPPORT - PROCLAIM DRG - neuromodulation.abbott The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. Additionally, all patients will be awake and conversant during the procedure to minimize the impact. 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. 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. To find Shipping Material Packaging Waste information, select Healthcare Professionals. If unpleasant sensations occur, the IPG should be turned off immediately. The long-term safety and effectiveness of this neurostimulation system has not been established beyond 5 years. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Do not crush, puncture, or burn these devices because explosion or fire may result. Note: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. 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. Battery care. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Instruct patients to use their neurostimulation system only after an authorized clinician has programmed the device and has trained the patient how to control stimulation and safely use the system. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Stabilizing the lead during insertion. Patients should be aware that during skydiving, the sudden jerking that occurs when the parachute opens may cause lead dislodgement or fractures, which may require surgery to repair or replace the lead. Neurostimulation systems have materials that come in contact or may come in contact with tissue. 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. Wireless use restrictions. Patients who are unable to properly operate the system. Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. 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. If lithotripsy must be used, do not focus the energy near the IPG. Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment. This system is contraindicated for patients who meet the following criteria: The following procedures are contraindicated for patients with a deep brain stimulation system. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief. Pain is not resolved. The placement of the leads involves some risk, as with any surgical procedure. Abbott's Proclaim XR Spinal Cord Stimulation System Now Offers This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. 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. Care and handling of components. Physicians should also discuss any risks of MRI with patients. Use caution when sedating the patient. Programmer and controller devices are not waterproof. 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. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. Charge density can be reduced by lowering the stimulation amplitude or pulse width. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. If unpleasant sensations occur, the device should be turned off immediately using the patient magnet. Do not handle the generator if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. 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. Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. Ask patients with neurostimulators to shut off the device temporarily while the scan is performed. 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. High stimulation outputs and charge density limits. Poor surgical risks. Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinsons disease. External defibrillators. Read this section to gather important prescription and safety information. Perception of higher levels of stimulation has been described by some patients as uncomfortable, painful, or jolting. The patient should be able and willing to use the patient controller and correctly interpret the icons and messages that appear on the screen. Abbott - Spinal Cord Stimulation This may occur once the lead is in place and is connected to the neurostimulator and activated. Safety Topic / Subject Spinal Cord Stimulation (SCS) Systems, Abbott and St. Jude Medical. Advise patients to not use their device when engaging in activities that might cause it to get wet, such as swimming or bathing. 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. 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. Anchoring leads. Component manipulation. If unpleasant sensations occur, the device should be turned off immediately. FDA approves new MRI compatibility for Abbott's Proclaim spinal cord Interference with other devices. Scuba diving or hyperbaric chambers. Advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan. Exit Surgery mode during intraoperative testing and after the procedure is completed. 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. Surgical complications and adverse events may be more frequent and severe in patients with diabetes. Surgical advice for removal. Neurostimulation should not be used for patients with comorbidities that could prevent successful implant or effective therapy. Electrosurgery. Implanted systems with non-Abbott leads have not been evaluated for safety while scuba diving or in hyperbaric chambers. Patients should cautiously approach such devices and should request help to bypass them. Skydiving, skiing, or hiking in the mountains. High-output ultrasonics and lithotripsy. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures.