MRI SUPPORT - PROCLAIM DRG - neuromodulation.abbott Advise patients to use their patient controller to communicate with their IPG only when needed because excessive communication with the IPG can shorten the remaining battery life. Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. Implanting physicians or anesthesiologists should consult practice guidelines for the intraoperative management of patients with diabetes. An expiration date (or use-before date) is printed on the packaging. Explosive or flammable gasses. and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). Household appliances. Patients should cautiously approach such devices and should request help to bypass them. 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.). Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. Conditional 5. Return any suspect components to Abbott Medical for evaluation. 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. Prodigy, Proclaim, and Proclaim XR Spinal Cord Stimulation (SCS Inaccurate ECG results may lead to inappropriate treatment of the patient. Maximize the distance between the implanted systems (minimum separation distance of approximately 8 cm (3 in.) The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. Instruct patients to designate a representative (family member or close friend) to notify any emergency medical personnel of their implanted neurostimulation system if emergency care is required. 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 effect of other implanted devices, including deep brain stimulators, peripheral nerve stimulators, implanted drug delivery pumps, and cochlear implants on the neurostimulation system are unknown. Confirm the neurostimulation system is functioning. Do not resterilize or reimplant an explanted system for any reason. IPG placement. These activities include but are not limited to climbing ladders and operating potentially dangerous machinery, power tools, and vehicles. It is extremely important to select patients appropriately for neurostimulation. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. 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. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Always be aware of the needle tip position. Use caution when positioning the needle to avoid unintended injury to surrounding anatomical structures. 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. Postural changes. When using a contralateral approach, advance the needle slowly into the epidural space and take caution as it enters. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Recharge-by date. 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. Higher amplitudes and wider pulse widths may indicate a system problem or a suboptimal lead placement. Electrosurgery. External defibrillators. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. When multiple leads are implanted, route the lead extensions so the area between them is minimized. Do not bend, kink, or use surgical instruments on the stylet, as this may damage it. If needed, return the equipment to Abbott Medical for service. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. Especially consider the following additional factors when selecting patients: Level of available support from a caregiver. Activities requiring coordination. Therapeutic magnets. Failure to provide strain relief may result in lead migration requiring a revision procedure. In some cases, symptoms may return with a greater intensity than what a patient experienced before system implantation (rebound effect). Carefully inspect the lead (in the sterile field) for damage after removing it from the sterile package. These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia). 737202011056 v5.0 | Item approved for U.S. use only. Do not handle the generator if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. High stimulation outputs. Skydiving, skiing, or hiking in the mountains. For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual. 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 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. 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. Bold New Spinal Cord Stimulation - Proclaim XR SCS System Electromagnetic interference (EMI). Instruct patients to use their neurostimulation system only after an authorized clinician has programmed the generator and has trained the patient on how to safely control stimulation and to charge the system. Use caution when securing the soft tissue anchor because damage to the anchor or lead can occur and result in failure of the system. Patient's physical ability, as patients with higher degrees of motor impairment might have difficulty with the physical requirements of monitoring the device. 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. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training. ), 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.). 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. Multiple leads. Advancing components. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) Disadvantages and Risks of Spinal Cord Stimulation Physicians should also discuss any risks of MRI with patients. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. 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. away from the generator and avoid placing any smart device in a pocket near the generator. Stimulation Modes. 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. Security, antitheft, and radiofrequency identification (RFID) devices. 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. 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. Package or component damage. Consider bipolar programming of both devices and use neurostimulation system settings that do not interfere with the function of the implantable cardiac system. 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. 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). (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). NOTE: During intraoperative testing, Surgery mode must be turned off for the neurostimulation system to function correctly. Return of symptoms and rebound effect. Falling and other traumatic accidents can damage shallowly implanted components such as the leads and extensions. Explosive and flammable gasses. Use appropriate sterile technique when implanting leads and the IPG. While charging the generator, patients may perceive an increase in temperature at the generator site. For CT procedures in which the medical device is in or immediately adjacent to the programmed scan range, the operator should: If practical, try to move external devices out of the scan range. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. 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. 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. 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.