Pope JE, Deer TR, Kramer J. 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. 1996. Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura. It is extremely important to select patients appropriately for neurostimulation. Component handling. The force of the instruments may damage the lead or stylet. Damage to the lead body can cause improper function and stimulation or stimulation to areas other than the intended target. Wireless use restrictions. 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. Implantation of multiple leads. However, advise patients who feel uncomfortable paresthesia during postural changes that they should not operate potentially dangerous equipment such as power tools, automobiles, or other motor vehicles. Pregnancy and nursing. Please read the Legal Notice for further details. If the operating field is bloody, wipe gloves, lead, stylet, and sheath before handling the lead. 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 operation of these devices could cause them to ignite, causing severe burns, injury, or death. Storage environment. Krames ES. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. Carefully inspect the lead (in the sterile field) for damage after removing it from the sterile package. Abbott designs chronic pain products to manage different kinds of pain. : Upgradable technology allows patients to benefit from advancements without surgery. 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. Nonadjacent leads and extensions have the possibility of creating a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible. Keep the device dry. Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura. **Precise pain in the foot, knee, hip or groin due to CRPS types I and II. Security, antitheft, and radiofrequency identification (RFID) devices. Access our product manuals and instructions for use. *When compared to traditional tonic spinal cord stimulation based on outcomes from the ACCURATE IDE study. In one study of DRG therapy1: Abbott developed DRG stimulation … Infections related to system implantation might require that the device be explanted. The Proclaim™ DRG Neurostimulator System treats chronic pain in the foot, knee, or groin in patients with Complex Regional Pain Syndrome (CRPS).1. The Proclaim DRG neurostimulator system lets patients and clinicians use wireless programming with convenient and familiar technology. Do not use the system if the use-before date has expired. 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. Physicians should also discuss any risks of MRI with patients. Component handling. In one study of DRG therapy1: Abbott developed DRG stimulation for people with focal chronic pain. Using surgical instruments. The DRG itself is a robust structure with a consistent location in the epidural, intraspinal space.9 The ganglia are encapsulated in a dural sleeve that tapers, which allows minimal cerebral spinal fluid (CSF) to surround it. Patients should cautiously approach such devices and should request help to bypass them. The equipment is not serviceable by the customer. If the operating field is bloody, wipe gloves, lead, stylet, and sheath before handling the lead. Exposure to body fluids or saline. Handle the device with care. Confirm the neurostimulation system is functioning correctly after the procedure. IPG disposal. 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. It is extremely important to select patients appropriately for neurostimulation. **Please note that in 1994, a consensus group of pain medicine experts gathered by the International Association for the Study of Pain (IASP) reviewed diagnostic criteria and agreed to rename reflex sympathetic dystrophy (RSD) and causalgia, as complex regional pain syndrome (CRPS) types I and II, respectively. Failure to do so may result in difficulty delivering the lead. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. By eliminating external cables and incorporating Apple† mobile digital devices and Bluetooth† wireless technology, our trial system is easier and less burdensome for patients to use — giving them the ability to focus on evaluating DRG stimulation instead of managing the system. 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. The equipment is not serviceable by the customer. In addition to those risks commonly associated with surgery, the following risks are associated with using this neurostimulation system: 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. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Bending the sheath. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. If lithotripsy must be used, do not focus the energy near the IPG. Prior to connection, exposure of the metal contacts, such as those on the connection end of a lead or extension, to body fluids or saline can lead to corrosion. 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. 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. Programmer and controller devices are not waterproof. Advise patients to inform their healthcare professional that they should not be exposed to diathermy treatment. Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura. US: Spinal column stimulation via epidural and intra-spinal 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.**. 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. Lead movement. We’re here to help you offer patients a chance to overcome their chronic pain and get back to living their best lives. We’ve got the answers you’re looking for. Do not use the system if the use-before date has expired. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. 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. Do not over-manipulate the sheath and lead system as this may result in trauma within the epidural space. The use of components not approved for use by Abbott Medical with this system may result in damage to the system and increased risk to the patient. Learn how neuromodulation can help you achieve better control of your chronic pain symptoms. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. 2. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Implantation of multiple leads. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. ***Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least two prior pharmacologic treatments from at least two different drug classes and continued their pharmacologic therapy during the clinical study. If unpleasant sensations occur, the device should be turned off immediately. This novel therapy option is proven to effectively deliver targeted treatment for patients suffering from focal chronic pain in the lower body.1,2, The Proclaim™ DRG Neurostimulator System provides clinically superior* therapy on a platform designed for patients’ convenience and comfort.2. Product materials. [prod, crx3, samplecontent, publish, crx3tar], Operation of machines, equipment, and vehicles, Security, antitheft, and radiofrequency identification (RFID) devices, People felt an average of 81.4 percent less pain at 12 months, With our Proclaim™ DRG Neurostimulator System, you can conveniently and discreetly adjust your own therapy using familiar Bluetooth, As we continue to advance our technology, your device can be kept up to date easily and painlessly through wireless software updates, Chronic pain that has lasted six months or more, Isolated chronic pain in a lower part of the body, such as the foot, knee, hip or groin, following an injury or surgical procedure. Diathermy is further prohibited because it may also damage the neurostimulation system components. IPG disposal. Perception of higher levels of stimulation has been described by some patients as uncomfortable, painful, or jolting. Find out how functional neurosurgeon Steven Falowski, M.D., used DRG stimulation to give Kam a whole new outlook on her daily life despite lower limb pain.

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