IPG placement. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Do not bring the suture needle in contact with an IPG, lead, or extension, or the component may be damaged. Before diving or using a hyperbaric chamber, patients should contact their physician to discuss the effects of high pressure on their implanted system. Detailed information on storage environment is provided in the appendix of this manual. Implantation of this neurostimulation system is contraindicated for the following: Patients for whom test stimulation is unsuccessful. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief 1. Pediatric use. This includes oxygen-enriched environments such as hyperbaric chambers. Needle positioning. Less serious disadvantages of spinal cord stimulation devices include: Fluctuations in stimulation. If needed, return the equipment to Abbott Medical for service. The system is intended to be used with leads and associated extensions that are compatible with the system. Patients who are unable to properly operate the system. Patient selection. Therapeutic radiation. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target. Carefully inspect the lead (in the sterile field) for damage after removing it from the sterile package. 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. 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. The Eterna SCS 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. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Do not handle the generator if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. 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. Pediatric use. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (if either occurs, turn off your IPG immediately. Clinician training. If needed, return the equipment to Abbott Medical for service. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. 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. Do not use the application if the operating system is compromised (that is, jailbroken). Before reinserting the sheath, verify there is no damage to the sheath. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. In addition to those risks commonly associated with surgery, the following risks are associated with using this neurostimulation system: Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your generator immediately.). Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment. 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 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. Patients should exercise reasonable caution when bathing. 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. Abbott offers two types of MR Conditional, fully implanted DBS configurations: WARNING: For an MR Conditional system, all implanted components must be approved MR Conditional models. 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. Electrosurgery. 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. Stimulation effectiveness. Electromagnetic interference (EMI). 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). Therapeutic radiation. If the sheath needs to be retracted from the epidural space, verify that the steering wing is rotated away from the needle mark no more than 90 degrees. 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 . Device modification. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or render the patient incapable of controlling the generator. Confirm implant locations and scan requirements for the patients system. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. Always perform removal with the patient conscious and able to give feedback. Operating the device near gas fumes or vapors could cause them to catch fire. It's small, discreet and available with Abbott's proprietary BurstDR stimulation, a new technology that's clinically proven to . Patient activities and environmental precautions. If the sheath is not responding to rotation, do not rotate the steering wing out of plane from the curve of the sheath more than 90 degrees. If two systems are implanted, ensure that at least 20 cm (8 in.) In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. 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. Keep the device dry. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. 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. 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. Device modification. Schu S, Gulve A, ElDabe S, et al. Wireless use restrictions. Consider seeking surgical advice if you cannot easily remove a lead. 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. Proclaim Plus Spinal Column Stimulation (SCS) System PRESCRIPTION AND SAFETY INFORMATION Read this section to gather important prescription and safety information. Failure to do so may result in difficulty delivering the lead. Damage to the system may not be immediately detectable. Therapeutic radiation. 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 damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. 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. Implantation of two systems. 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. Back pain. 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. The safety and efficacy of implantation of leads implanted above the T10 vertebral level have not been evaluated. Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the management of disabling tremor. The abrupt cessation of stimulation for any reason will probably cause disease symptoms to return. To prevent unintended stimulation, do not modify the operating system in any way. Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs (If either occurs, turn off your IPG immediately.). To prevent unintended stimulation, do not modify the generator software in any way. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. Advise patients who experience these types of stimulation changes to turn down the amplitude or turn off the IPG before making extreme posture changes or abrupt movements such as stretching, lifting their arms over their heads, or exercising. Stabilizing the lead during insertion. 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. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. Expected effect from cessation of therapy, should disease symptoms return unexpectedly. Advance the needle and guidewire slowly. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Confirm the neurostimulation system is functioning correctly after the procedure. 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. Operation of machinery and equipment. Poor surgical risks. Surgical complications and adverse events may be more frequent and severe in patients with diabetes. Safety Topic / Subject Spinal Cord Stimulation (SCS) Systems, Abbott and St. Jude Medical. 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. Return all explanted IPGs to Abbott Medical for safe disposal. Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the neurostimulation system. Advise patients to not use their device when engaging in activities that might cause it to get wet, such as swimming or bathing. 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. In some cases, symptoms may return with a greater intensity than what a patient experienced before system implantation (rebound effect). Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief. Avoid excessive stimulation. Return any suspect components to Abbott Medical for evaluation. Unlike other SCS systems, the ProclaimXR SCS system is recharge free. 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. Providing strain relief. 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. 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. To find Shipping Material Packaging Waste information, select Healthcare Professionals. 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. Radiofrequency or microwave ablation. 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. Use extreme care to not damage the lead with the sharp point of the tunneling tool. Implant heating. 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. Clinician training. 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. Devices with one-hour recharge per day. For more information, see the clinician programmer manual. 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. 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. Component manipulation by patient. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. Exit Surgery mode during intraoperative testing and after the procedure is completed. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. Use extreme care when using sharp instruments or electrosurgery devices around the lead to avoid damaging the lead. Single-use, sterile device. 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. Bathing. Lead movement. 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. Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. This system is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation. The Proclaim XR SCS system can provide relief to . Explosive and flammable gasses. This damage could result in loss of therapy, requiring additional surgery for system replacement. Make the Bold Choice Long-term safety and effectiveness. All components listed must be implanted unless noted as "optional." between lead ends is recommended); Verify that the neurostimulation system is not interfering with the function of the implanted cardiac system; and. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) 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. Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. Neurosurgery Pain Management Orthopaedic Surgery The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. Always perform removal of implanted components with the patient conscious and able to give feedback. Learn more about the scan details for our MR Conditional products below. 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. Remove the stylet from the lead only when satisfied with lead placement. Lead movement. Other neurostimulators may restrict the allowed MRI power or scan location, preventing imaging on your shoulders or vital organs in your torso. Follow proper infection control procedures. 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.