If interference occurs, try holding the phone to the other ear or turning off the phone. 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,. 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. ), 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.). 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. Failure to do so can damage or cut the lead or sheath. Use caution when positioning the needle to avoid unintended injury to surrounding anatomical structures. Removing each item in slow movements while holding the remaining components in place will assist this process. Therapeutic magnets (e.g., magnets used in pillows, mattress pads, back belts, knee braces, wrist bands, and insoles) may unintentionally cause the neurostimulation system to turn on or off. 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. The system is intended to be used with leads and associated extensions that are compatible with the system. Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible. 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. Poor surgical risks. 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. 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. Patients should not operate potentially dangerous machinery, power tools, or vehicles or engage in any activity that could be unsafe if their symptoms were to unexpectedly return. External defibrillators. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the suppression of disabling upper extremity tremor in adult essential tremor patients whose tremor is not adequately controlled by medications and where the tremor constitutes a significant functional disability. Store components and their packaging where they will not come in contact with liquids of any kind. Risk of depression, suicidal ideations, and suicide. Stylet handling. Suicidal ideation, suicide attempts, and suicide are events that have also been reported. 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. 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. IPG disposal. For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual. Return them to Abbott Medical for proper disposal. If the stylet is removed from the lead, it may be difficult to reinsert it. Detailed information on storage environment is provided in the appendix of this manual. Advise your patient to avoid manipulating the implanted system components (e.g., the neurostimulator, the burr hole site). Object Category Spinal Cord Stimulation Systems: St. Jude Medical. Implantation at vertebral levels above T10. Skydiving, skiing, or hiking in the mountains. 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. For more information, see the clinician programmer manual. (2) The method of its application or use. Patient training. 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. Read this section to gather important prescription and safety information. 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. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Therapeutic radiation. Diathermy is further prohibited because it may also damage the neurostimulation system components. Patients should exercise reasonable caution when bathing. Implanting physicians or anesthesiologists should consult practice guidelines for the intraoperative management of patients with diabetes. Less serious disadvantages of spinal cord stimulation devices include: Fluctuations in stimulation. 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. WARNING:For a neurostimulation system to be MR Conditional, all implanted components must be approved MR Conditional models and implanted in approved locations according to the following table. Failure to do so may result in difficulty delivering the lead. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for at least six weeks after implantation. Patient's age, as very young or very old patients may have difficulty performing required monitoring of the device. 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. Poor surgical risks. Consumer goods and electronic devices. Return the explanted IPG to Abbott Medical. However, current data shows that most patients using BurstDR Stimulation Therapy do not experience paresthesia. Component disposal. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system: Other active implanted devices. 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). Sources of therapeutic radiation include therapeutic X-rays, cobalt machines, and linear accelerators. 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). Handle the device with care. If two systems are implanted, ensure that at least 20 cm (8 in) separates the implanted IPGs to minimize unintended interaction with other system 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. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) 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. 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. 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). Keep them dry to avoid damage. Patients will receive an identification card to carry with them that will inform emergency medical personnel of their implanted system. Both the Intellis and Vanta SCS devices integrate SureScan MRI technology, providing MRI access anywhere in the body with normal operating mode power settings. External defibrillation can cause induced currents in the leadextension portion of the neurostimulation system. 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. The system can be programmed to use parameter settings outside the range of those used in the clinical studies. Use extreme care when handling system components. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. 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.