Diathermy is further prohibited because it may also damage the neurostimulation system components. If unpleasant sensations occur, the device should be turned off immediately. Diathermy is further prohibited because it may also damage the neurostimulation system components. 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. Clinician training. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for at least six weeks after implantation. Follow proper infection control procedures. INDICATIONS FOR USE This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. 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. Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. Educate patients and caregivers about these potential risks prior to implantation, and be sure that they know about the importance of ongoing support and follow-up, including when to contact their health care provider. Case damage. Overcommunicating with the IPG. Thorough psychiatric screening should be performed. The following procedures are contraindicated for patients that have been implanted with this device: Diathermy therapy. Make the Bold Choice Higher amplitudes and wider pulse widths may indicate a system problem or a suboptimal lead placement. Wireless use restrictions. If needed, return the equipment to Abbott Medical for service. Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient. This damage could result in loss of therapy, requiring additional surgery for system replacement. Patients who failed to receive effective pain relief during trial stimulation are contraindicated to process to the permanent implant procedure. Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the management of disabling tremor. Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment. Select patients appropriately for deep brain stimulation. Do not bend, kink, or stretch the lead body, sheaths, or other components as this may result in damage to the component and poor function. 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. Clinicians should be familiar with deep brain stimulation therapy and be experienced in the diagnosis and treatment of the indication for which the deep brain stimulation components are being used. 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. 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. Patients should exercise reasonable caution when bathing. 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. Anchoring leads. The safety and effectiveness of neurostimulation for pediatric use have 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. If unpleasant sensations occur, the device should be turned off immediately using the patient magnet. Stabilizing the lead during insertion. Damage to the system may not be immediately detectable. Application modification. The operation of the clinician programmer or patient controller could cause them to ignite, causing severe burns, injury, or death. six to eight weeks after implantation of a neurostimulation system. Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket. Operating the device near gas fumes or vapors could cause them to catch fire. Keep them dry to avoid damage. Do not use excessive pressure when injecting through the sheath. This may occur once the lead is in place and is connected to the neurostimulator and activated. 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. High-output ultrasonics and lithotripsy. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. 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. Pediatric use. 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. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. Follow proper infection control procedures. Wireless use restrictions. Advise patients to not use their device when engaging in activities that might cause it to get wet, such as swimming or bathing. If multiple leads or extensions are implanted, the leads and extensions should be routed in close proximity. If multiple leads are implanted, leads and extensions should be routed in close proximity. 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. Package or component damage. Programmer and controller devices are not waterproof. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. Caution patients to not make unauthorized changes to physician-established stimulation parameters. ); 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. Do not place the IPG deeper than 4.0 cm (1.57 in) because the clinician programmer or patient controller may not communicate effectively with the IPG. Long-term safety and effectiveness. 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). Store components and their packaging where they will not come in contact with liquids of any kind. Component disposal. If they must go through a gate or doorway containing this type of device, patients should turn off their generator and proceed with caution, being sure to move through the device quickly. Safety has not been established for radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system. Use care when reinserting a stylet. Use extreme care when handling system components. In addition, a component must be implanted in its approved location as listed in the following table or the entire implanted system is considered MRUnsafe. However, advise patients who feel uncomfortable paresthesia during postural changes that they should not operate potentially dangerous equipment such as power tools, automobiles, or other motor vehicles. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. Patients should also avoid any activities that would be potentially unsafe if their symptoms were to return unexpectedly. See Full System Components below if the patient has an IPG and extensions implanted. Device modification. Scuba diving and hyperbaric chambers. Pregnancy and nursing. The severity of any surgical complication may be greater in patients with diabetes, particularly those with inadequate pre-operative glycemic control. The Proclaim TM SCS System is also the first upgradeable and recharge-free spinal cord stimulation system capable of delivering both tonic stimulation and Abbott's proprietary BurstDR stimulation waveform, a superior therapy designed to more closely mimic how pain signals travel to the brain. While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. 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. 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. Activities that include sudden, excessive or repetitive bending, twisting, or stretching can cause component fracture or dislodgement. Before reinserting the sheath, verify there is no damage to the sheath. Changes in blood glucose levels in response to any adverse effect 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. Advise patients to inform their healthcare professional that they should not be exposed to diathermy treatment. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. 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. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. These electrically insulated wires transmit electrical impulses to the nerves targeted by the neuromodulation device. Safety has not been established for TMS or ECT in patients who have an implanted neurostimulation system. 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. To correct the effects of typical interference, keep wireless communication equipment at least 15 cm (6 in) from the IPG. Programmer use. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. Scuba diving or hyperbaric chambers. Neurostimulation should not be used on patients who are poor surgical candidates. Securing the anchor. If interference occurs, try holding the phone to the other ear or turning off the phone. Use extreme care when handling system components prior to implantation. Needle positioning. PATIENTS If needed, return the equipment to Abbott Medical for service. 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. Use extreme care when removing the lead stylet, the delivery sheath, and the needle to ensure that the distal tip of the lead remains in the desired location. 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. 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. Surgical complications and adverse events may be more frequent and severe in patients with diabetes. Therapeutic radiation. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. Do not use the application if the operating system is compromised (i.e., jailbroken). This neurostimulation system is contraindicated for patients who are. Do not bend the sheath without the lead inside the sheath, as this will permanently kink it and make it difficult to deploy the lead. We offer products that are MR Conditional for spinal cord stimulation (SCS) and dorsal root ganglion (DRG) therapy. During implant procedures, if electrosurgery devices must be used, take the following actions: Complete any electrosurgery procedures before connecting the leads or extensions to the neurostimulator. 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. radiofrequency identification (RFID) devices. Return all explanted IPGs to Abbott Medical for safe disposal. Securing the IPG. Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation. These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system. The equipment is not serviceable by the customer. 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. 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. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. *Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least two prior pharmacologic treatments from at least two different drug classes and continued their pharmacologic therapy during the clinical study. For adverse effects observed in SCS clinical studies, refer to the clinical summaries manual for SCS systems. The implanted components of this neurostimulation system are intended for a single use only. 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. Diathermy therapy. Sheath retraction. These activities include but are not limited to climbing ladders and operating potentially dangerous machinery, power tools, and vehicles. All patients are advised to inform their healthcare professional that they should not be exposed to diathermy treatment. 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's age, as very young or very old patients may have difficulty performing required monitoring of the device. All components listed must be implanted unless noted as "optional." Wireless use restrictions. High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control. External defibrillators. Avoid placing equipment components directly over other electronic devices. If lithotripsy must be used, do not focus the energy near the generator. If the sheath has been kinked during delivery, slowly retract through the needle with the curve facing the same direction as the bevel. The abrupt cessation of stimulation for any reason will probably cause disease symptoms to return. Nonadjacent leads and extensions have the possibility of creating a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Inaccurate ECG results may lead to inappropriate treatment of the patient. Return any suspect components to Abbott Medical for evaluation. 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 Read this section to gather important prescription and safety information. Do not crush, puncture, or burn these devices because explosion or fire may result. 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.**. 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. Pregnancy and nursing. To prevent unintended stimulation, do not modify the generator software in any way. 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 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). 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. Product materials. 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. Neurostimulation systems have materials that come in contact or may come in contact with tissue. 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. Return them to Abbott Medical for proper disposal. Damage to the system may not be immediately detectable. 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. If two systems are implanted, ensure that at least 20 cm (8 in.) Both the Intellis and Vanta SCS devices integrate SureScan MRI technology, providing MRI access anywhere in the body with normal operating mode power settings. The device should be turned off and the doctor contacted if this occurs. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. The Eterna SCS System is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation. New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. Infection. The Eterna Spinal Cord Stimulation (SCS) System is designed to deliver low-intensity electrical impulses to nerve structures. 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 BurstDR stimulation mode has not been evaluated for effectiveness in the diabetic peripheral neuropathy (DPN) population. Nerve damage may result from traumatic or surgical nerve injury. To correct the effect of interference with other devices, turn off the equipment or increase the distance between the equipment and the device being affected. Remove the stylet from the lead only when satisfied with lead placement. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. 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). 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. Neurostimulation should not be used for patients with comorbidities that could prevent successful implant or effective therapy. 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. 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. Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. For this reason, programming at frequencies less than 30 Hz is not recommended. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. 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. Clinician training. 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. Using the tunneling tool. Abandoned leads and replacement leads. A recharge-by date is printed on the packaging. Sterile components in this kit have been sterilized using ethylene oxide (EtO) gas before shipment and are supplied in sterile packaging to permit direct introduction into the sterile field. 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. Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system. Dural puncture can occur if needle or guidewire is advanced aggressively once loss of resistance is achieved. 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. 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.
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