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In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient. The implanted components of this neurostimulation system are intended for a single use only. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. Learn more about the scan details for our MR Conditional products below. Suicidal ideation, suicide attempts, and suicide are events that have also been reported. However, current data shows that most patients using BurstDR stimulation therapy do not experience paresthesia. communication equipment (such as microwave transmitters and high-power amateur transmitters). 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. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. Patient's physical ability, as patients with higher degrees of motor impairment might have difficulty with the physical requirements of monitoring the device. Our Invisible Trial System TM is a discreet, app . 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), radiofrequency identification (RFID) devices, some medical procedures (such as therapeutic radiation, static magnetic field [SMF] therapy, and electromagnetic lithotripsy), and some medical devices (such as bone growth stimulators, transcutaneous electrical nerve stimulation [TENS] devices, dental drills, and ultrasonic probes). Conscious sedation during removal. Generators contain batteries as well as other potentially hazardous materials. Failure to do so may cause harm to the patient such as damage to the dura. High stimulation outputs. Charge density can be reduced by lowering the stimulation amplitude or pulse width. Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Implantation of multiple leads. 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. Confirm that the neurostimulation system is functioning correctly during the implant procedure, before closing the neurostimulator pocket, and after the implant procedure. six to eight weeks after implantation of a neurostimulation system. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. Avoid excessive stimulation. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Other active implantable devices. Confirm the neurostimulation system is functioning. Electromagnetic interference (EMI). This equipment is not serviceable by the customer. Sources of therapeutic radiation include therapeutic X-rays, cobalt machines, and linear accelerators. Schu S, Gulve A, ElDabe S, et al. 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. Failure to do so can damage or cut the lead or sheath. Use extreme care when handling system components prior to implantation. These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. Device modification. 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. 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. Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. 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. Lead damage from tools. 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. Security, antitheft, and radiofrequency identification (RFID) devices. Keep the device dry. Always perform removal of implanted components with the patient conscious and able to give feedback. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief 1. 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. Scuba diving and hyperbaric chambers. Recharge-by date. 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. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. 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). 737202011056 v5.0 | Item approved for U.S. use only. Wireless use restrictions. Care and handling of components. Sheath insertion precaution. Return any suspect components to Abbott Medical for evaluation. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Complete any electrosurgery before connecting the leads or extensions to the neurostimulator. Do not suture directly onto the lead to avoid damaging the lead. External defibrillation can cause induced currents in the leadextension portion of the neurostimulation system. Do not use the application if the operating system is compromised (i.e., jailbroken). Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. Neurostimulation systems have materials that come in contact or may come in contact with tissue. Safety Topic / Subject Spinal Cord Stimulation (SCS) Systems, Abbott and St. Jude Medical. Select patients appropriately for deep brain stimulation. 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. Read this section to gather important prescription and safety information. Advise patients who experience these types of stimulation changes to turn down the amplitude or turn off the IPG before making extreme posture changes or abrupt movements such as stretching, lifting their arms over their heads, or exercising. Store components and their packaging where they will not come in contact with liquids of any kind. 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). Mobile phones. Before diving or using a hyperbaric chamber, patients should contact their physician to discuss the effects of high pressure on their implanted system. Failure to provide strain relief may result in lead migration requiring a revision procedure. 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. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. maximize the distance between the implanted systems; Use in patients with diabetes. However, current data shows that most patients using BurstDR Stimulation Therapy do not experience paresthesia. The clinician programmer and patient controller are not waterproof. 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. Explosive and flammable gasses. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. Safety and effectiveness of neurostimulation for pediatric use have not been established. 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. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions. Using surgical instruments. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. Surgical complications and adverse events may be more frequent and severe in patients with diabetes. Bending the sheath. 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). 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. If unpleasant sensations occur, the device should be turned off immediately. For less than 30 m (100 ft) of water or pressures below 4.0 ATA, durations of less than 60 minutes are recommended. Other neurostimulators may restrict the allowed MRI power or scan location, preventing imaging on your shoulders or vital organs in your torso. 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 If needed, return the equipment to Abbott Medical for service. Bathing. 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. Damage to shallow implants. If multiple leads are implanted, leads and extensions should be routed in close proximity. Keep dry to avoid damage. 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. Patient training. Do not bring the suture needle in contact with an IPG, lead, or extension, or the component may be damaged. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (if either occurs, turn off your IPG immediately. Poor surgical risks. Instruct patients to contact their physician if they experience any adverse effects, such as unusual pain or discomfort during stimulation and swelling, redness, tenderness, or pain around implanted components. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. 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 activities and environmental precautions. Patients should not dive below 30 m (100 ft) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Use extreme care when handling system components. Using the tunneling tool. Return the explanted IPG to Abbott Medical. Falling and other traumatic accidents can damage shallowly implanted components such as the leads and extensions. Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the neurostimulation system. Especially consider the following additional factors when selecting patients: Level of available support from a caregiver. 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. Product materials. Securing the IPG. Only apply software updates that are published directly by Abbott Medical. The force of the instruments may damage the lead or stylet. If lithotripsy must be used, do not focus the energy near the IPG. After defibrillation, confirm the neurostimulation system is still working. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. 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. Surgical advice for removal. Additional Disadvantages. High-output ultrasonics and lithotripsy. Sheath retraction. separates the implanted generators to minimize unintended interaction with other system components. Needle insertion. 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. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. Transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). Electromagnetic interference (EMI). External defibrillators. To prevent unintended stimulation, do not modify the operating system in any way. This neurostimulation 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, intractable low back and leg pain, and diabetic peripheral neuropathy of the lower extremities. Component manipulation by patients. (2) The method of its application or use. Wireless use restrictions.