If unpleasant sensations occur, the device should be turned off immediately. Equipment is not serviceable by the customer. Inserting the anchor. Our Invisible Trial System TM is a discreet, app . 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. Implantation of this neurostimulation system is contraindicated for the following: Patients for whom test stimulation is unsuccessful. Ultrasonic scanning equipment. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. Placing the IPG. Exposure of the metal contacts, such as those on the connection end of a lead or extension, to body fluids or saline prior to connection can lead to corrosion. Using surgical instruments. Other neurostimulators may restrict the allowed MRI power or scan location, preventing imaging on your shoulders or vital organs in your torso. Security, antitheft, and radiofrequency identification (RFID) devices. Unlike other SCS systems, the Proclaim XR SCS system is recharge free. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. Case damage. Sheath retraction. 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. Patients should cautiously approach such devices and should request help to bypass them. It is extremely important to select patients appropriately for neurostimulation. If unpleasant sensations occur, the IPG should be turned off immediately. Return all explanted components to Abbott Medical for safe disposal. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Return all explanted components to Abbott Medical for safe disposal. Poor surgical risks. Wireless use restrictions. Implant heating. 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. Battery care. Patients will receive an identification card to carry with them that will inform emergency medical personnel of their implanted system. Security, antitheft, and radiofrequency identification (RFID) devices. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) 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, cause heating at the lead tip that could result in tissue damage, and induce voltage through the lead that could jolt or shock the patient. Safety and effectiveness of neurostimulation for pediatric use have not been established. Consider seeking surgical advice if you cannot easily remove a lead. Battery precaution. Sudden loss of stimulation may cause patients to fall or lose control of equipment or vehicles, injure others, or bring injury upon themselves. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. ); 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. Number of leads implanted. Implanting physicians should be experienced in stereotactic and functional neurosurgery. Infections may require that the device be explanted. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. Implantation of two systems. 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. 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. Pregnancy and nursing. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. Neuromodulation. Ensure the patients neurostimulation system is in MRI mode. Note: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. If the sheath has been kinked during delivery, slowly retract through the needle with the curve facing the same direction as the bevel. The clinician programmer and patient controller are not waterproof. Before your patient undergoes an MRI scan: Confirm the MR Conditional components and location of the system. Electrosurgery. Avoid excessive stimulation. Skin erosion. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. Pediatric use. 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 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. Mobile phones. The use of high-output devices, such as an electrohydraulic lithotriptor, may damage the electronic circuitry of an implanted generator. The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. Wireless use restrictions. 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. Lead inspection. Patients should not use this neurostimulation system if they are pregnant or nursing. This may occur once the lead is in place and is connected to the neurostimulator and activated. Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. The device should be turned off and the doctor contacted if this occurs. 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. 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. The Proclaim XR implantable pulse generator (IPG) is a novel device designed to supply low-dose BurstDR stimulation in a primary cell battery guaranteed to last 5-10 years with appropriate programming. To prevent injury or damage to the system, do not modify the equipment. 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. Advise patients to not use the patient controller when engaging in activities that might cause it to get wet, such as swimming or bathing. Advance the needle and guidewire slowly. Coagulopathies. Follow proper infection control procedures. Security, antitheft, and radiofrequency identification (RFID) devices. Surgical advice for removal. Safety has not been established for TMS or ECT in patients who have an implanted neurostimulation system. separates the implanted generators to minimize unintended interaction with other system components. Patients should avoid charging their generator over an incision that has not completely healed. 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. 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. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia). Patients should not dive below 30 m (100 ft) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Keep dry to avoid damage. Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop 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. 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. Neurosurgery Pain Management Orthopaedic Surgery In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. Keep the device dry. 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. Implantation of two systems. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Component disposal. Securing the anchor. 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. Only apply software updates that are published directly by Abbott Medical. If the case of the implantable pulse generator (IPG) is pierced or ruptured, severe burns could result from exposure to battery chemicals. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or render the patient incapable of controlling the generator. 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. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) NOTE: During intraoperative testing, Surgery mode must be turned off for the neurostimulation system to function correctly. 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. The following additional considerations should be made for patients with diabetes: A pre-operative risk assessment should be performed for patients with diabetes who are at high risk for ischemic heart disease, those with autonomic neuropathy or renal failure, and patients with a Hemoglobin A1C (HbA1c) 8% (64 mmol/mol). 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. The U.S. Food and Drug Administration (FDA) has approved Abbott 's request to expand the magnetic resonance imaging (MRI) compatibility with its Proclaim XR spinal cord stimulation system with . A risk of brain tissue damage exists with parameter settings using high amplitudes and wide pulse widths. The system is intended to be used with leads and associated extensions that are compatible with the system. Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control. Sheath insertion warning. Lead movement. Magnetic resonance imaging (MRI). Emergency procedures. 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. This damage could result in loss of therapy, requiring additional surgery for system replacement. 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. Recharge-by date. Scuba diving or hyperbaric chambers. Electrosurgery. Overcommunicating with the IPG. 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 this reason, programming at frequencies less than 30 Hz is not recommended. Interference with wireless equipment. Sources of therapeutic radiation include therapeutic X-rays, cobalt machines, and linear accelerators. For more information about MR Conditional products, visit the Abbott Medical product information page atneuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. 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.