Safety has not been established for TMS or ECT in patients who have an implanted neurostimulation system. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. Patient's mental capacity, as patients with cognitive impairment or those prone to developing dementia would likely have difficulty performing device-related tasks without assistance. 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. Patients should cautiously approach such devices and should request help to bypass them. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the management of disabling tremor. Radiofrequency or microwave ablation. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. communication equipment (such as microwave transmitters and high-power amateur transmitters). Return them to Abbott Medical for proper disposal. Damage to shallow implants. 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. 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. Case damage. Consumer goods and electronic devices. Proclaim DRG System | Abbott 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. 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. The following precautions apply to this neurostimulation system. Unless otherwise specified, all product and service names appearing in this Internet site are trademarks owned by or licensed to Abbott, its subsidiaries or affiliates. (2) The method of its application or use. MRI SUPPORT - PROCLAIM DRG - neuromodulation.abbott Clinician training. Package or component damage. The system can be programmed to use parameter settings outside the range of those used in the clinical studies. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. Electromagnetic interference (EMI). If unpleasant sensations occur, turn off stimulation immediately. IPGs contain batteries as well as other potentially hazardous materials. Placing the IPG. 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. Ensure the neurostimulator is off before initiating an electrocardiogram (ECG). 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). If lithotripsy must be used, do not focus the energy near the IPG. Infection. Patient's visual ability to read the patient controller screen. Poor surgical risks. Patients should exercise reasonable caution when participating in activities that require coordination, including those that they were able to perform prior to receiving DBS therapy (for example, swimming). Use appropriate sterile technique when implanting leads and the IPG. This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. Diathermy is further prohibited because it may also damage the neurostimulation system components. Do not resterilize or reimplant an explanted system for any reason. Neurostimulation should not be used for patients with comorbidities that could prevent successful implant or effective therapy. Device modification. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Activities requiring excessive twisting or stretching. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system: Other active implanted devices. External defibrillation can cause induced currents in the leadextension portion of the neurostimulation system. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. 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. 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. 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. 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. Control of the patient controller. Anchoring leads. Using the tunneling tool. Operating the device near gas fumes or vapors could cause them to catch fire. Failure to do so may result in difficulty delivering the lead. 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. 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. Devices with one-hour recharge per day. Do not bring the suture needle in contact with an IPG, lead, or extension, or the component may be damaged. Failure to push the short end of the soft tissue anchor into the ligament or fascia may result in lead migration and a procedure to revise the lead location. Nerve damage may result from traumatic or surgical nerve injury. Component manipulation by patient. During the 2000s about a dozen companies sold and manufactured SCS systems worldwide, including the "big three" (Boston Scientific, Abbott/St. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. 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. To find Shipping Material Packaging Waste information, select Healthcare Professionals. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. Lead movement. 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. Note: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. Therapeutic magnets. Learn more about the scan details for our MR Conditional products below. 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. 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. ); complications from unusual physiological variations in patients, including foreign body rejection phenomena; paralysis (loss of motor function, inability to move); Possible deep brain stimulation complications. 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 patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. Component handling. Return of symptoms and rebound effect. If this date has been reached or has been exceeded before the date of implantation, the generator should be charged prior to implantation. This includes oxygen-enriched environments such as hyperbaric chambers. Keep dry to avoid damage. Proclaim XR Spinal Cord Stimulation (SCS) System, Model 3660 and Model 3662 . 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. To prevent injury or damage to the system, do not modify the equipment. If multiple leads are implanted, leads and extensions should be routed in close proximity. If radiation therapy is required, the area over the implanted generator should be shielded with lead. For patients who do not feel paresthesia, sudden stimulation changes are less likely to occur and distract them while operating motorized vehicles, machinery, or equipment. and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). If the sheath has been kinked during delivery, slowly retract through the needle with the curve facing the same direction as the bevel. Electrical medical treatment. 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. Patient's physical ability, as patients with higher degrees of motor impairment might have difficulty with the physical requirements of monitoring the device. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). 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. However, some patients may experience a decrease or increase in the perceived level of stimulation. Make the Bold Choice Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient. Follow proper infection control procedures. Risk of depression, suicidal ideations, and suicide. Always perform removal with the patient conscious and able to give feedback. 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. Operation of machines, equipment, and vehicles. Skin erosion. To correct the effects of typical interference, keep wireless communication equipment at least 15 cm (6 in) from the IPG. Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation. Pregnancy and nursing. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (if either occurs, turn off your IPG immediately. Transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) Long-term safety and effectiveness. Do not place TENS electrodes so that the TENS current passes over any part of the neurostimulation system. Handle the programmers and controllers with care. Diathermy is further prohibited because it may also damage the neurostimulation system components. Do not use the application if the operating system is compromised (that is, jailbroken). Abbott - Spinal Cord Stimulation Therapeutic magnets (e.g., magnets used in pillows, mattress pads, back belts, knee braces, wrist bands, and insoles) may unintentionally cause the neurostimulation system to turn on or off. 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. Advise your patient to avoid manipulating the implanted system components (e.g., the neurostimulator, the burr hole site). Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. Neurostimulation should not be used on patients who are poor surgical candidates. High-output ultrasonics and lithotripsy. Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) for the management of intractable, chronic dystonia, including primary and secondary dystonia, for patients who are at least 7 years old. After any surgery, check the neurostimulation system for the following: Check the neurostimulator to ensure Surgery mode has been turned off, even if Surgery mode was not turned on at the beginning or during the procedure. Restricted areas. If the patient requires a CT scan, all stimulation should be turned off before the procedure. Neurosurgery Pain Management Orthopaedic Surgery Electromagnetic interference (EMI). Read this section to gather important prescription and safety information. Approved models and implant locations for an MR Conditional lead-only system. Pediatric use. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. While charging the generator, patients may perceive an increase in temperature at the generator site. INTENDED USE This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Do not over-manipulate the sheath and lead system as this may result in trauma within the epidural space. Scanning under different conditions may cause device malfunction, severe patient injury, or death. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.). Spinal Cord Stimulator Systems - Boston Scientific Clinician training. Magnetic resonance imaging (MRI). 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. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief. Up to two IPGs, leads, extensions, and burr hole covers may be implanted. Implanted cardiac systems. Return any suspect components to Abbott Medical for evaluation. 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. Schu S, Gulve A, ElDabe S, et al. High-output ultrasonics and lithotripsy. Using surgical instruments. Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. Safety Topic / Subject Spinal Cord Stimulation (SCS) Systems, Abbott and St. Jude Medical. Operation of machinery and equipment. For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. Electrosurgery. Bending the sheath. For more information, see the clinician programmer manual. Household appliances that contain magnets (e.g., refrigerators, freezers, inductive cooktops, stereo speakers, mobile telephones, cordless telephones, standard wired telephones, AM/FM radios, and some power tools) may unintentionally cause the neurostimulation system to turn on or turn off. Getting an MRI | Medtronic 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.
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