Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. 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. 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. This neurostimulation system is indicated for spinal column stimulation via epidural and intraspinal 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. Schu S, Gulve A, ElDabe S, et al. Case damage. Precision Spectra Spinal Cord Stimulator System Innovation Focused on Pain Relief Designed for more coverage, more flexibility, and advanced control, the Precision Spectra SCS System is engineered to provide more pain relief to a broader spectrum of patients. separates the implanted IPGs to minimize unintended interaction with other system components. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Lead movement. Clinician training. Security, antitheft, and radiofrequency identification (RFID) devices. If the stylet is removed from the lead, it may be difficult to reinsert it. Ensure the neurostimulator is off before initiating an electrocardiogram (ECG). Operation of machines, equipment, and vehicles. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems (available online at medical.abbott/manuals). 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, which are implanted, electrically insulated wires that transmit electrical impulses to the target nerves This equipment is not serviceable by the customer. 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. For complete and comprehensive MRI support, parameters, and precautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. 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,. These patients should not climb ladders or participate in activities where postural changes or abrupt movements could alter the perception of stimulation intensity and cause patients to fall or lose control of equipment or vehicles or injure others. Pressures below 30 m (100 ft.) of water (or above 4.0 ATA) could damage the neurostimulation system. Therefore, physicians should consider the following: Preoperatively, assess patients for the risks of depression and suicide. Patients will receive an identification card to carry with them that will inform emergency medical personnel of their implanted system. Patients should exercise reasonable caution when participating in activities that require coordination, including those that they were able to perform prior to receiving DBS therapy (for example, swimming). Do not use the clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. Therapeutic magnets. Closely monitor patients for signs of infection, delayed wound healing, or cerebrospinal fluid (CSF) leakage as the severity of these complications may be greater in patients with diabetes. 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 . Neurosurgery Pain Management Orthopaedic Surgery If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Generators contain batteries as well as other potentially hazardous materials. Do not bring the suture needle in contact with an IPG, lead, or extension, or the component may be damaged. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems. The Eterna Spinal Cord Stimulation (SCS) System is designed to deliver low-intensity electrical impulses to nerve structures. 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. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Application modification. Return any suspect components to Abbott Medical for evaluation. Abbott's Prodigy, Proclaim, and Proclaim XR SCS Systems are used to help manage chronic, intractable pain of the trunk and/or limbs, including one-sided or two-sided pain associated with the . The system is intended to be used with leads and associated extensions that are compatible with the system. Sterile components in this kit have been sterilized using ethylene oxide (EtO) gas before shipment and are supplied in sterile packaging to permit direct introduction into the sterile field. Component handling. Patients should not dive below 30 m (100 ft) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Advise patients to inform their healthcare professional that they should not be exposed to diathermy treatment. Component manipulation. Inserting the anchor. 74372 MAT-2215216 v3.0 | Item approved for U.S. use only. INDICATIONS FOR USE New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. 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. 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. Ensure the patients neurostimulation system is in MRI mode. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Store components and their packaging where they will not come in contact with liquids of any kind. Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards. communication equipment (such as microwave transmitters and high-power amateur transmitters). Scuba diving or hyperbaric chambers. These activities include but are not limited to climbing ladders and operating potentially dangerous machinery, power tools, and vehicles. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. Pediatric use. 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. maximize the distance between the implanted systems; Use in patients with diabetes. Overcommunicating with the IPG. Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation. Do not use excessive pressure when injecting through the sheath. Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. Placement of lead connection in neck. 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. 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. Learn more about the scan details for our MR Conditional products below. Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. Surgical complications include, but are not limited to, the following: intracranial hemorrhage (which can lead to stroke, paralysis, or death); cerebrospinal fluid leakage or cerebrospinal fluid abnormality; persistent pain at surgery site or IPG site; brachial plexus injury (nerves to chest, shoulder and arm); postoperative pain, stress, or discomfort; hemiparesis (muscular weakness or partial paralysis on one side of body); ballism or hemiballism (uncontrollable movements on both or only one side of the body); confusiontransient, nocturnal or ongoing; cognitive impairment, including delirium, dementia, disorientation, psychosis and speech difficulties; pulmonary embolism (sudden blood vessel obstruction); aborted procedures (air embolism, unable to find target, surgical complication, etc. If the neurostimulator is on during an ECG, the ECG recording may be adversely affected, resulting in inaccurate ECG results. Before using an electrosurgery device, place the device in Surgery Mode using the patient controller app or clinician programmer app. If this date has been reached or has been exceeded before the date of implantation, the generator should be charged prior to implantation. 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 cautiously approach such devices and should request help to bypass them. To find Shipping Material Packaging Waste information, select Healthcare Professionals. Preventing infection. All patients are advised to inform their healthcare professional that they should not be exposed to diathermy treatment. Damage to the system may not be immediately detectable. Failure to do so may result in difficulty delivering the lead. Needle insertion. The safety and efficacy of the implantation of greater than four leads have not been evaluated. Some patients may be implanted with the components that make up a Magnetic Resonance (MR) Conditional system, which allows them to receive an MRI scan if all the requirements for the implanted components and for scanning are met. Infection. 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. External defibrillators. If lithotripsy must be used, do not focus the energy near the IPG. Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura. Jude, Medtronic).Most of the early models of these devices were considered MR Unsafe primarily due to the theoretical risk of spinal cord injury from heating of the the electrode tip by RF-induced currents (the so-called antenna effect). 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. Abandoned leads and replacement leads. The IPG should be placed into the pocket, at a depth not to exceed 4 cm (1.57 in), with the logo side facing toward the skin surface. During the 2000s about a dozen companies sold and manufactured SCS systems worldwide, including the "big three" (Boston Scientific, Abbott/St. 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. ), 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.). Operation of machinery and equipment. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb.) Both the Intellis and Vanta SCS devices integrate SureScan MRI technology, providing MRI access anywhere in the body with normal operating mode power settings. 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. 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. Application modification. 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.
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