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. Generators contain batteries as well as other potentially hazardous materials. Needle insertion. Wireless use restrictions. Electrical medical treatment. The device should be turned off and the doctor contacted if this occurs. For adverse effects observed in SCS clinical studies, refer to the clinical summaries manual for SCS systems. This neurostimulation system is contraindicated for patients who are. Cremation. Unlike other SCS systems, the ProclaimXR SCS system is recharge free. Expected effect from cessation of therapy, should disease symptoms return unexpectedly. 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. Activities requiring coordination. Perception of higher levels of stimulation has been described by some patients as uncomfortable, painful, or jolting. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. 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,. Conscious sedation during removal. Recharge-by date. If needed, return the equipment to Abbott Medical for service. 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. Infections may require that the device be explanted. Preventing infection. Make the Bold Choice 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. 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. Handle the device with care. All components listed must be implanted unless noted as "optional." Return of symptoms and rebound effect. 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. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) Radiofrequency or microwave ablation. 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. 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. A multicenter, prospective trial to assess the safety and performance of the spinal modulation dorsal root ganglion neurostimulator system in the treatment of chronic pain. This assessment should consider both the risk of depression and suicide as well as the potential clinical benefits of DBS therapy for the condition being treated. External defibrillation can cause induced currents in the leadextension portion of the neurostimulation system. Batteries can explode, leak, or melt if disassembled, shorted (when battery connections contact metal), or exposed to high temperature or fire. Less serious disadvantages of spinal cord stimulation devices include: Fluctuations in stimulation. Case damage. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. A summary of the safety and clinical performance (SSCP) for these devices will be published at https://ec.europa.eu/tools/eudamed by the Notified Bodies in accordance with the requirements of EU MDR 2017/745 and associated timelines. 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. 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. Application modification. Therefore, physicians should consider the following: Preoperatively, assess patients for the risks of depression and suicide. Electromagnetic interference (EMI). The force of the instruments may damage the lead or stylet. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. 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. 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. 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. Introduction: Spinal cord stimulation is becoming an increasingly used modality for the treatment of chronic pain. Implantation of multiple leads. The long-term safety associated with multiple implants, leads left in place without use, replacement of leads, multiple implants into the target structure, and lead explant is unknown. 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). Sudden loss of stimulation may cause patients to fall or lose control of equipment or vehicles, injure others, or bring injury upon themselves. Transcutaneous electrical nerve stimulation (TENS). To prevent injury or damage to the system, do not modify the equipment. Return all explanted components to Abbott Medical for safe disposal. 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. Using the tunneling tool. Back pain. Do not use the clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Handle the programmers and controllers with care. Care and handling of components. Consumer goods and electronic devices. 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. Wireless use restrictions. Neurosurgery Pain Management Orthopaedic Surgery The following precautions apply to this neurostimulation system. Component manipulation by patients. Nerve damage may result from traumatic or surgical nerve injury. Place the neurostimulator in Surgery mode before using an electrosurgery device. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Diathermy is further prohibited because it may also damage the neurostimulation system components. Always perform removal with the patient conscious and able to give feedback. 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. Securing the IPG. If the sheath has been kinked during delivery, slowly retract through the needle with the curve facing the same direction as the bevel. The Prodigy MRI SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott's smallest implantable pulse generator (IPG). Operating the device near gas fumes or vapors could cause them to catch fire. Electrosurgery. Device components. 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. Magnetic resonance imaging (MRI). Ask patients with neurostimulators to shut off the device temporarily while the scan is performed. Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible. Safety has not been established for radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. In patients who have areas of increased sensitivity to heat, consider placing the implant where the patient has normal sensation. Scuba diving and hyperbaric chambers. Case damage. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. Neuromodulation. Additional risks to the patients, as a result of the placement and stimulation of the lead in the area of the dorsal root ganglion (DRG), include pain from setting the stimulation parameters too high. Lead inspection. 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. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. Damage to the system may not be immediately detectable. Security, antitheft, and radiofrequency identification (RFID) devices. When using a contralateral approach, advance the needle slowly into the epidural space and take caution as it enters. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Return any suspect components to Abbott Medical for evaluation. Do not use a clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Up to two leads, lead protection boots, and burr hole covers may be implanted. PDF View Shellock R & D Services, Inc. email: . Avoid placing equipment components directly over other electronic devices. Patients who are unable to properly operate the system. It's small, discreet and available with Abbott's proprietary BurstDR stimulation, a new technology that's clinically proven to . 737202011056 v5.0 | Item approved for U.S. use only. Do not crush, puncture, or burn the IPG because explosion or fire may result. 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. Bending the sheath. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. Infection. 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. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system. Patients with implanted Abbott leads should avoid scuba diving in more than 30 m (100 ft) of water or entering hyperbaric chambers above 4.0 atmospheres absolute (ATA) for any length of time, as this may damage the neurostimulation system. High stimulation outputs. Inaccurate ECG results may lead to inappropriate treatment of the patient. Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. Before your patient undergoes an MRI scan: Confirm the MR Conditional components and location of the system. Activities requiring excessive twisting or stretching. Physicians should also discuss any risks of MRI with patients. Set the electrosurgery device to the lowest possible energy setting. Conscious sedation. This means you can get hassle-free pain relief with a battery that lasts up to 10 years at low-dose settings** without ever needing to charge the system. Neurostimulation should not be used on patients who are poor surgical candidates. Do not place TENS electrodes so that the TENS current passes over any part of the neurostimulation system. 72784 MAT-2215217 v2.0 | Item approved for U.S. use only. Keep dry to avoid damage. 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. away from the generator and avoid placing any smart device in a pocket near the generator. Set the electrosurgery device to the lowest possible energy setting. Electrosurgery. If unpleasant sensations occur, the device should be turned off immediately using the patient magnet. 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. Return all explanted generators to Abbott Medical for safe disposal. If the implanted system contains components or models not listed in the followingtable, then the system is considered MR Unsafe. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient controller.
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