Failure to provide strain relief may result in lead migration requiring a revision procedure. Proclaim XR SCS System Meaningful relief from chronic pain. 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. Scanning under different conditions may cause device malfunction, severe patient injury, or death. 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. For less than 30 m (100 ft) of water or pressures below 4.0 ATA, durations of less than 60 minutes are recommended. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. Therapeutic radiation. If the implanted system contains any other components or models than what appears in the following tables, then the system is considered untested for an MRI environment. Bold New Spinal Cord Stimulation - Proclaim XR SCS System 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. Infections may require that the device be explanted. 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. Computed tomography (CT). Poor surgical risks. Lasting Relief through our smallest system yet. Long-term safety and effectiveness. Advise patients to not use their device when engaging in activities that might cause it to get wet, such as swimming or bathing. Prior to connection, exposure of the metal contacts, such as those on the connection end of a lead or extension, to body fluids or saline can lead to corrosion. Energy from diathermy can be transferred through the implanted system and cause tissue damage at the location of the implanted electrodes, resulting in severe injury or death. Programmer use. 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. Securing the lead with the lead stabilizer will mitigate this risk. and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). Diathermy is further prohibited because it may also damage the neurostimulation system components. After defibrillation, confirm the neurostimulation system is still working. Loss of coordination is a potential side effect of DBS therapy. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket. Return all explanted IPGs to Abbott Medical for safe disposal. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for six to eight weeks after implantation of a neurostimulation system. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Implantation of two systems. The placement of the leads involves some risk, as with any surgical procedure. If the packaging has been compromised, the device is beyond its expiration date, or the sterile package or device show signs of damage, do not use the device as it may be compromised and could cause harm to the patient. Battery care. Follow proper infection control procedures. Object Category Spinal Cord Stimulation Systems: St. Jude Medical. If needed, return the equipment to Abbott Medical for service. Scuba diving or hyperbaric chambers. Operation of machinery and equipment. During the 2000s about a dozen companies sold and manufactured SCS systems worldwide, including the "big three" (Boston Scientific, Abbott/St. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. 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). This equipment is not serviceable by the customer. A summary of the safety and clinical performance (SSCP) for these devices will be published at https://ec.europa.eu/tools/eudamed by the Notified Bodies in accordance with the requirements of EU MDR 2017/745 and associated timelines. 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. Infection. ), 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 or breakage, Stimulation in unwanted places (such as stimulation of the chest wall), Epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement of a lead in the epidural space Cerebrospinal fluid (CSF) leakage, Paralysis, weakness, clumsiness, numbness, sensory loss, or pain below the level of the implant, Pain or bleeding where the needle was inserted, Seroma (mass or swelling) at the implant site, Allergic or rejection response to device or implant materials, Hardware malfunction that requires replacing the neurostimulator, Pain from a noninjurious stimulus to the skin or an exaggerated sense of pain, Formation of reactive tissue in the epidural space around the lead, which can cause delayed spinal cord compression and paralysis and requires surgical intervention (Time to onset can range 23 from weeks to many years after implant.). Closely monitor patients for signs of infection, delayed wound healing, or cerebrospinal fluid (CSF) leakage as the severity of these complications may be greater in patients with diabetes. Confirm that the neurostimulation system is functioning correctly during the implant procedure, before closing the neurostimulator pocket, and after the implant procedure. The effect of mobile phones on deep brain stimulation is unknown. The system is intended to be used with leads and associated extensions that are compatible with the system. If any component of the implanted neurostimulation system, such as an IPG, lead, or extension, does not meet the requirements for an MR Conditional system, do not perform an MRI scan. Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. Safety and effectiveness of neurostimulation for pediatric use have not been established. Component manipulation. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. Confirm implant locations and scan requirements for the patients system. 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. For complete MRI guidance, parameters and cautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. 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. Ensure the patients neurostimulation system is in MRI mode. 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. Confirm the neurostimulation system is functioning correctly after the procedure. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Stimulation Modes. These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. When multiple leads are implanted, route the lead extensions so the area between them is minimized. Electromagnetic interference (EMI). 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. Patients should avoid charging their generator over an incision that has not completely healed. Read this section to gather important prescription and safety information. New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. Patients should exercise reasonable caution when bathing. 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 Use caution when positioning the needle to avoid unintended injury to surrounding anatomical structures. Monitor the patients blood glucose levels in the perioperative period and instruct the patient to continue to monitor glucose levels as they may fluctuate as a response to surgery or to complications. All patients are advised to inform their healthcare professional that they should not be exposed to diathermy treatment. Pediatric use. Insertion of a sheath without the lead may result in dural puncture. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Needle positioning. Implantation of two systems. The system is intended to be used with leads and associated extensions that are compatible with the system. 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. Follow proper infection control procedures. Inserting the anchor. Sheath retraction. separates the implanted generators to minimize unintended interaction with other system components. MRI Support | Abbott If interference occurs, try holding the phone to the other ear or turning off the phone. This damage could result in loss of therapy, requiring additional surgery for system replacement. An expiration date (or use-before date) is printed on the packaging. Keep them dry to avoid damage. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. The following procedures are contraindicated for patients that have been implanted with this device: Diathermy therapy. Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment. 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). 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. 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. To prevent injury or damage to the system, do not modify the equipment. FDA Approves Abbott's Spinal Cord Stimulation for People Living with Implant heating. Electrical medical treatment. Scuba diving or hyperbaric chambers. Spinal cord stimulation of the dorsal root ganglion for groin pain-a retrospective review. Lead movement. FDA Expands MRI Compatibility With Spinal Stimulation for Pain 74373 MAT-2300644 v2.0 | Item approved for U.S. use only. During the implant procedure, if an electrosurgery device must be used, take the following actions:. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. Have the patient check the device for proper functioning, even if the device was turned off. Damage to shallow implants. Follow proper infection control procedures. Additional risks to the patients, as a result of the placement and stimulation of the lead in the area of the dorsal root ganglion (DRG), include pain from setting the stimulation parameters too high. 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. 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. 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. Avoid excessive stimulation. Important note: For CT procedures that require scanning over the medical device continuously for more than a few seconds, as with CT perfusion or interventional exams, attending staff should be ready to take emergency measures to treat adverse reactions if they occur. For specific indications, contraindications, instructions, warnings, precautions, and adverse effects about system components available in your country or region, see the approved clinician's manual for those components. 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. If the lead extensions are routed in a loop, the loop will increase the potential for electromagnetic interference (EMI). 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. Proclaim Plus: The Next Burst in Chronic Pain Care | Abbott Newsroom maximize the distance between the implanted systems; Use in patients with diabetes. 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. Advise patients to not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. Advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan. Single-use, sterile device. 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. Back pain. Sheath insertion warning. Pediatric use. The safety and effectiveness of neurostimulation for pediatric use have not been established. Patients should cautiously approach such devices and should request help to bypass them. 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). 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. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. INDICATIONS FOR USE Patient selection. FDA approves new MRI compatibility for Abbott's Proclaim spinal cord Security, antitheft, and radiofrequency identification (RFID) devices. 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. Consider seeking surgical advice if you cannot easily remove a lead. If the sheath has been kinked during delivery, slowly retract through the needle with the curve facing the same direction as the bevel. Implantation of multiple leads. Neurostimulation systems have materials that come in contact or may come in contact with tissue. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. 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. CRPS II (causalgia) is defined as a painful condition arising from damage to a nerve. Low frequencies. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. The long-term effectiveness of dorsal root ganglion (DRG) stimulation has not been documented, and not all patients realize the long-term benefits from DRG stimulation. External defibrillators. Lead movement. Needle insertion. Caution patients to not make unauthorized changes to physician-established stimulation parameters. 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. 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. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. Physicians need to be aware of the risk and possible interaction between a neurostimulation system and an implanted cardiac system, such as a pacemaker or defibrillator. Security, antitheft, and radiofrequency identification (RFID) devices. Implanted cardiac systems. Charge density can be reduced by lowering the stimulation amplitude or pulse width. Consumer goods and electronic devices. Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. 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. Wireless use restrictions. Patient's visual ability to read the patient controller screen. To prevent unintended stimulation, do not modify the operating system in any way. Device components. Damage to the system may not be immediately detectable. Patients should be advised to not use therapeutic magnets. This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. Coagulopathies. Do not use surgical instruments to handle the lead. This may occur once the lead is in place and is connected to the neurostimulator and activated. The Proclaim XR SCS System is an implantable spinal cord stimulation device designed to allow patients to attain relief from chronic pain of the trunk and limbs. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. Proclaim DRG System | Abbott If radiation therapy is required, the area over the implanted IPG should be shielded with lead. 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. Transcutaneous electrical nerve stimulation (TENS). INTENDED USE This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Surgical complications and adverse events may be more frequent and severe in patients with diabetes. 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. 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. Unauthorized changes to stimulation parameters. 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. Use caution when sedating the patient. Conditional 5. Radiofrequency or microwave ablation. Infection. separates the implanted IPGs to minimize unintended interaction with other system components. Sheath insertion precaution. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems. Patients should cautiously approach such devices and should request help to bypass them. Proclaim XR Spinal Cord Stimulation (SCS) System, Model 3660 and Model 3662 . Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Diathermy therapy. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. Overcommunicating with the IPG. 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. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. Magnetic resonance imaging (MRI). Damage to the system may not be immediately detectable. Guidance and conditions for MRI safety with neuromodulation systems, neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html, Upper buttock, low back, midline, flank or abdomen, Upper buttock, low back, flank, or abdomen, 6170 directional lead, 30 cm, 0.5-mm spacing, black, Fully implanted in the brain, routed under the scalp, 6010 Guardian cranial burr hole cover system, Fully implanted in the brain, routed under the scalp and connected to an extension, Head and neck, routed to the IPG on the same side of the body as the IPG, Lead-only systems, which consist of at least one implanted lead connected to a lead protection boot, as well as an optional cranial burr hole cover, Full systems, which consist of at least one implantable pulse generator (IPG), lead and extension, as well as an optional cranial burr hole cover.
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