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Infection. Neurostimulation should not be used on patients who are poor surgical candidates. Implantation of two systems. Keep them dry to avoid damage. 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. Stylet handling. Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible. Lead handling. Sheath insertion precaution. Note: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. If the sheath has been kinked during delivery, slowly retract through the needle with the curve facing the same direction as the bevel. Interference with wireless equipment. Safety Info ID# Safety Topic / Subject Article Text 294: Spinal Cord Stimulation Systems: St. Jude Medical: Genesis, GenesisXP, GenesisRC, Eon, Eon C, Eon Mini, and Renew The Genesis, GenesisXP, GenesisRC, Eon, EonC, Eon Mini, and Renew neuromodulation devices (St. Jude Medical) used for spinal cord stimul. Safety and effectiveness of neurostimulation for pediatric use have not been established. Emergency procedures. However, some patients may experience a decrease or increase in the perceived level of stimulation. Patients will receive an identification card to carry with them that will inform emergency medical personnel of their implanted system. Patients should avoid charging their generator over an incision that has not completely healed. 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. Select patients appropriately for deep brain stimulation. Failure to do so may result in damage to the sheath. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted. 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. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. Back pain. If the operating field is bloody, wipe gloves, lead, stylet, and sheath before handling the lead. During the implant procedure, if an electrosurgery device must be used, take the following actions:. Lead insertion through sheath. maximize the distance between the implanted systems; Use in patients with diabetes. In patients who have areas of increased sensitivity to heat, consider placing the implant where the patient has normal sensation. 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. Object Category Spinal Cord Stimulation Systems: St. Jude Medical. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. The patient should be able and willing to use the patient controller and correctly interpret the icons and messages that appear on the screen. Generator disposal. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. Do not use the application if the operating system is compromised (i.e., jailbroken). Patients should cautiously approach such devices and should request help to bypass them. Remove leads slowly. If gas fumes or vapors catch fire, it could cause severe burns, injury, or death. 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. The system is intended to be used with leads and associated extensions that are compatible with the system. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. Electrosurgery. During the 2000s about a dozen companies sold and manufactured SCS systems worldwide, including the "big three" (Boston Scientific, Abbott/St. 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. When multiple leads are implanted, route the lead extensions so the area between them is minimized. Lead movement. If use of electrocautery is necessary, place the neurostimulator in Surgery mode using the clinician programmer app or the patient controller app before using an electrosurgery device. Diathermy is further prohibited because it may also damage the neurostimulation system components. Operation of machines, equipment, and vehicles. Handle the device with care. The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. Neurosurgery Pain Management Orthopaedic Surgery Component disposal. Consider seeking surgical advice if you cannot easily remove a lead. Additional Disadvantages. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. 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. Return them to Abbott Medical for proper disposal. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.). 737202011056 v5.0 | Item approved for U.S. use only. Conversely, the other active implanted device may interfere with the operation of the neurostimulation system. Avoid placing equipment components directly over other electronic devices. For more information about MR Conditional neurostimulation 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 neurostimulation systems(available online atmedical.abbott/manuals). For more information about MR Conditional neurostimulation 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 neurostimulation systems (available online atmedical.abbott/manuals). Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. Nonadjacent leads and extensions have the possibility of creating a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Some equipment in home, work, medical, and public environments can generate EMI that is strong enough to interfere with the operation of a neurostimulation system or damage system components. If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals. 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. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. If lithotripsy must be used, do not focus the energy near the IPG. separates the implanted IPGs to minimize unintended interaction with other system components. A recharge-by date is printed on the packaging. Security, antitheft, and radiofrequency identification (RFID) devices. The patient must be instructed to not rub or exert pressure on implanted components through the skin as this may cause lead dislodgement leading to stimulation at the implant site, IPG inversion leading to the inability to communicate with the device, or skin erosion that can lead to another surgical procedure or possible infection. 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. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. Warn patients to seek medical guidance before entering environments that could adversely affect the operation of the implanted device, including areas protected by a warning notice preventing entry by patients fitted with a pacemaker. The Prodigy MRI SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott's smallest implantable pulse generator (IPG). The tip of the sheath may whip around and could cause harm to the patient. 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. 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. Electrical medical treatment. 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. Do not implant a device if the sterile package or components show signs of damage, if the sterile seal is ruptured, or if contamination is suspected for any reason. Do not suture directly onto the lead to avoid damaging the lead. Case damage. Care and handling of components. INTENDED USE This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. Consumer goods and electronic devices. Before beginning a CT scan, the operator should use CT scout views to determine if implanted or externally worn electronic medical devices are present and if so, their location relative to the programmed scan range. Failure to do so may result in difficulty delivering the lead. 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. If a system does not meet the MR Conditional requirements, consider it MR Unsafe. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. If unpleasant sensations occur, turn off stimulation immediately. Patients who are unable to properly operate the system. Wireless use restrictions. 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 and intractable low back and leg pain. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. Do not over-manipulate the sheath and lead system as this may result in trauma within the epidural space. Conditional 5. If the implanted system contains components or models not listed in the followingtable, then the system is considered MR Unsafe. After defibrillation, confirm the neurostimulation system is still working. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. Surgical complications and adverse events may be more frequent and severe in patients with diabetes. 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. 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. Loss of coordination is a potential side effect of DBS therapy. 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 prevent unintended stimulation, do not modify the operating system in any way. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. The device should be turned off and the doctor contacted if this occurs. Sudden loss of stimulation may cause patients to fall or lose control of equipment or vehicles, injure others, or bring injury upon themselves. 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. 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. Unlike other SCS systems, the Proclaim XR SCS system is recharge free. To avoid the risk of skin erosion, implant components at the appropriate depth and inform patients to avoid touching their skin where components are implanted. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. 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. System testing. 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. Return any suspect components to Abbott Medical for evaluation. Unauthorized changes to stimulation parameters. For this reason, programming at frequencies less than 30 Hz is not recommended. 71409MAT-2116350 v4.0 | Item approved for U.S. use only. A multicenter, prospective trial to assess the safety and performance of the spinal modulation dorsal root ganglion neurostimulator system in the treatment of chronic pain. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. 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. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. Implant heating. 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. Jude, Medtronic).Most of the early models of these devices were considered MR Unsafe primarily due to the theoretical risk of spinal cord injury from heating of the the electrode tip by RF-induced currents (the so-called antenna effect). Do not resterilize or reimplant an explanted system for any reason. Risk of depression, suicidal ideations, and suicide. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. The system can be programmed to use parameter settings outside the range of those used in the clinical studies. Patients should cautiously approach such devices and should request help to bypass them. Minimize X-ray exposure to the implanted or externally worn electronic medical device by using the lowest possible X-ray tube current consistent with obtaining the required image quality and by making sure that the X-ray beam does not dwell over the device for more than a few seconds. Patients should not dive below 30 m (100 ft) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Physicians should also consider underlying factors, such as previous neurological injury or prescribed medications (anticoagulants), that may predispose a patient to the risk of bleeding. 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. Keep dry to avoid damage. Use caution when positioning the needle to avoid unintended injury to surrounding anatomical structures. Activities requiring excessive twisting or stretching. Interference with other devices. Learn more about the scan details for our MR Conditional products below. Keep the device dry. Use extreme care when handling system components. 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. 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. Pregnancy and nursing. For more information about MR Conditional neurostimulation 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 neurostimulation systems(available online atmedical.abbott/manuals). Implanting physicians should be experienced in stereotactic and functional neurosurgery. High-output ultrasonics and lithotripsy. Extension of the upper torso or neck may cause lead movement and alter the stimulation field (especially with leads in the cervical area), resulting in overstimulation or ineffective stimulation. Wireless use restrictions. 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. 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. 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. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Do not use the clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Advance the needle and guidewire slowly. 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.