The use of components not approved for use by Abbott Medical with this system may result in damage to the system and increased risk to the patient. Failure to do so may cause harm to the patient such as damage to the dura. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. Do not use excessive force to push the lead or sheath into the neural foramen as this may result in permanent or transient nerve damage. 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). Infection. Patients should avoid activities that may put undue stress on the implanted components of the neurostimulation system. The clinician programmer and patient controller are not waterproof. Patients should be advised to not use therapeutic magnets. Learn more about the scan details for our MR Conditional products below. Lead damage from tools. away from the generator and avoid placing any smart device in a pocket near the generator. Batteries can explode, leak, or melt if disassembled, shorted (when battery connections contact metal), or exposed to high temperature or fire. Control of the patient controller. Therapeutic radiation. Safety has not been established for radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system. Handle the device with care. Sheath retraction. Number of leads implanted. When multiple leads are implanted, route the lead extensions so the area between them is minimized. While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. If the lead extensions are routed in a loop, the loop will increase the potential for electromagnetic interference (EMI). Do not bend, kink, or use surgical instruments on the stylet, as this may damage it. 72750 MAT-2215018 v2.0 | Item approved for U.S. use only. maximize the distance between the implanted systems; Use in patients with diabetes. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. Unauthorized changes to stimulation parameters. Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control. We know that MRI scans are an important and trusted visualization tooland thats why weve designed our devices and technologies to fit as seamlessly as possible into this critical step in your diagnostic workflow. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted. Do not use the system if the use-before date has expired. If needed, return the equipment to Abbott Medical for service. If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (if either occurs, turn off your IPG immediately. Return all explanted components to Abbott Medical for safe disposal. Sheath insertion warning. Advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan. 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. Conditional 5. Physicians should also discuss any risks of MRI with patients. Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. Expiration date. Safety and effectiveness has not been established for patients with a neurological disease other than Parkinsons disease or essential tremor, previous surgical ablation procedures, dementia, coagulopathies, or moderate to severe depression; patients under 22 years; implantation in targets other than the STN for Parkinson's disease and the VIM for essential tremor; patients with an active implantable device; patients requiring MRI. The neurostimulator is controlled by a trained operator and the starting point for the stimulation will be set to the lowest available settings. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Patients should not dive below 30 m (100 ft) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Follow proper infection control procedures. Wireless use restrictions. Only apply software updates that are published directly by Abbott Medical. Component manipulation by patients. Security, antitheft, and radiofrequency identification (RFID) devices. Failure to provide strain relief may result in lead migration requiring a revision procedure. However, current data shows that most patients using BurstDR stimulation therapy do not experience paresthesia. 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. Do not resterilize or reimplant an explanted system for any reason. Have the patient check the device for proper functioning, even if the device was turned off. Scuba diving or hyperbaric chambers. Safety has not been established for TMS or ECT in patients who have an implanted neurostimulation system. Up to two leads, lead protection boots, and burr hole covers may be implanted. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Advise patients to inform their healthcare professional that they cannot undergo the following procedures: Diathermy (short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy), Electroshock therapy and transcranial magnetic stimulation (TMS). The BurstDR stimulation mode has not been evaluated for effectiveness in the diabetic peripheral neuropathy (DPN) population. Component disposal. Transcutaneous electrical nerve stimulation (TENS). 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. 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. 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. and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). Excessive lead migration may require reoperation to replace the leads. separates the implanted IPGs to minimize unintended interaction with other system components. Exposure of the metal contacts, such as those on the connection end of a lead or extension, to body fluids or saline prior to connection can lead to corrosion. See Full System Components below if the patient has an IPG and extensions implanted. Make the Bold Choice Generator disposal. Poor surgical risks. 74373 MAT-2300644 v2.0 | Item approved for U.S. use only. Patients will receive an identification card to carry with them that will inform emergency medical personnel of their implanted system. If needed, return the equipment to Abbott Medical for service. Patient selection. Always remove the trial leads before implanting the implant leads to avoid the risk of infection that may cause death if the leads are not removed. Detailed information on storage environment is provided in the appendix of this manual. Surgical advice for removal. If a patient experiences new or worsening depression or suicidal ideation, manage these symptoms appropriately. The safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. 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. For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual. Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards. Before your patient undergoes an MRI scan: Confirm the MR Conditional components and location of the system. Electrosurgery. away from the generator and avoid placing any smart device in a pocket near the generator. This system is contraindicated for patients who meet the following criteria: The following procedures are contraindicated for patients with a deep brain stimulation system. Implanting physicians should be experienced in stereotactic and functional neurosurgery. Do not use the application if the operating system is compromised (i.e., jailbroken). 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. 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. Operation of machines, equipment, and vehicles. High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. The website that you have requested also may not be optimized for your screen size. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. 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. Household appliances. If this date has been reached or has been exceeded before the date of implantation, the generator should be charged prior to implantation. The system is intended to be used with leads and associated extensions that are compatible with the system. IPGs contain batteries as well as other potentially hazardous materials. Return any suspect components to Abbott Medical for evaluation. Removing a kinked sheath. Clinician programmers, patient controllers, and chargers are not waterproof. Implanted systems with non-Abbott leads have not been evaluated for safety while scuba diving or in hyperbaric chambers. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. Safety and effectiveness of neurostimulation for pediatric use have not been established. Patient training. Damage to the system may not be immediately detectable. 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. Before diving or using a hyperbaric chamber, patients should contact their physician to discuss the effects of high pressure on their implanted system. Generators contain batteries as well as other potentially hazardous materials. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. FDA's expanded . Use caution when securing the soft tissue anchor because damage to the anchor or lead can occur and result in failure of the 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. Return any suspect components to Abbott Medical for evaluation. 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. Precision Spectra Spinal Cord Stimulator System Innovation Focused on Pain Relief Designed for more coverage, more flexibility, and advanced control, the Precision Spectra SCS System is engineered to provide more pain relief to a broader spectrum of patients. between lead ends is recommended); Verify that the neurostimulation system is not interfering with the function of the implanted cardiac system; and. If multiple leads or extensions are implanted, the leads and extensions should be routed in close proximity. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. Electromagnetic interference (EMI). This includes oxygen-enriched environments such as hyperbaric chambers. Electromagnetic interference (EMI). Abbott's Prodigy, Proclaim, and Proclaim XR SCS Systems are used to help manage chronic, intractable pain of the trunk and/or limbs, including one-sided or two-sided pain associated with the . Read this section to gather important prescription and safety information. Patients using therapy that generates paresthesia should turn off stimulation before operating motorized vehicles, such as automobiles, or potentially dangerous machinery and equipment because sudden stimulation changes may distract them from properly operating it. Higher amplitudes and wider pulse widths may indicate a system problem or a suboptimal lead placement. If unpleasant sensations occur, the device should be turned off immediately using the patient magnet. 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. Product materials. Case damage. 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. INDICATIONS FOR USE Return all explanted components to Abbott Medical for safe disposal. To prevent unintended stimulation, do not modify the operating system in any way. Infection. 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. Additional Disadvantages. 71409MAT-2116350 v4.0 | Item approved for U.S. use only. To prevent injury or damage to the system, do not modify the equipment. Placing the IPG. Always perform removal of implanted components with the patient conscious and able to give feedback. Patients who are unable to properly operate the system. Operation of machinery and equipment. Carefully inspect the lead (in the sterile field) for damage after removing it from the sterile package. 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. Exposure to body fluids or saline. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator.