Therapeutic radiation. PDF View Shellock R & D Services, Inc. email: . This neurostimulation system is contraindicated for patients who are. Securing the lead with the lead stabilizer will mitigate this risk. Free from the hassles of recharging. Radiofrequency or microwave ablation. Advise patients to inform their healthcare professional that they should not be exposed to diathermy treatment. Remove leads slowly. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. Abbott offers two types of MR Conditional, fully implanted DBS configurations: WARNING: For an MR Conditional system, all implanted components must be approved MR Conditional models. Needle insertion. Coagulopathies. 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). 737202011056 v5.0 | Item approved for U.S. use only. Insertion of a sheath without the lead may result in dural puncture. Inserting the anchor. Postural changes. six to eight weeks after implantation of a neurostimulation system. The neurostimulation system is indicated for the following conditions: Bilateral stimulation of the subthalamic nucleus (STN) or the internal globus pallidus (GPi) as an adjunctive therapy to reduce some of the symptoms of advanced levodopa-responsive Parkinsons disease that are not adequately controlled by medications. ABBOTT PARK, Ill., Jan. 26, 2023 /PRNewswire/ -- Abbott (NYSE: ABT) announced today that the U.S. Food and Drug Administration (FDA) has approved its Proclaim XR spinal cord stimulation (SCS) system to treat painful diabetic peripheral neuropathy (DPN), a debilitating complication of diabetes. Operation of machines, equipment, and vehicles. If the implanted system contains components or models not listed in the followingtable, then the system is considered MR Unsafe. Transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). Interference with wireless equipment. Patients should cautiously approach such devices and should request help to bypass them. However, current data shows that most patients using BurstDR Stimulation Therapy do not experience paresthesia. Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation. Advance the needle and guidewire slowly. Generators contain batteries as well as other potentially hazardous materials. Confirm the neurostimulation system is functioning. communication equipment (such as microwave transmitters and high-power amateur transmitters). Explosive and flammable gasses. Proclaim XR Spinal Cord Stimulation (SCS) System, Model 3660 and Model 3662 . 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. External defibrillation can cause induced currents in the lead-extension portion of the neurostimulation system. Computed tomography (CT). 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. 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. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. Consider seeking surgical advice if you cannot easily remove a lead. Storage environment. 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. Electrocardiograms. To correct the effects of typical interference, keep wireless communication equipment at least 15 cm (6 in) from the IPG. Device components. 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.). Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. Wireless use restrictions. Long-term safety and effectiveness. Component fracture or dislodgement may result in loss of stimulation, intermittent stimulation, stimulation at the fracture site, and additional surgery to replace or reposition the component. The equipment is not serviceable by the customer. Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. Wireless use restrictions. Safety and effectiveness has not been established for patients with a neurological disease other than Parkinsons disease or essential tremor, previous surgical ablation procedures, dementia, coagulopathies, or moderate to severe depression; patients under 22 years; implantation in targets other than the STN for Parkinson's disease and the VIM for essential tremor; patients with an active implantable device; patients requiring MRI. At the core of this patient-centric advancement is a battery that can last up to 10 years at low-dose settings** without the hassles of recharging. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient controller. Expected effect from cessation of therapy, should disease symptoms return unexpectedly. 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. 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. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. commercial electrical equipment (such as arc welders and induction furnaces). Caution patients to not make unauthorized changes to physician-established stimulation parameters. Wireless use restrictions. Approved models and implant locations for an MR Conditional lead-only system. 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. Use extreme care when using sharp instruments or electrosurgery devices around the lead to avoid damaging the lead. High stimulation outputs. If radiation therapy is required, the area over the implanted generator should be shielded with lead. The neurostimulator is controlled by a trained operator and the starting point for the stimulation will be set to the lowest available settings. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. (2) The method of its application or use. 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. Return all explanted components to Abbott Medical for safe disposal. If unpleasant sensations occur, turn off stimulation immediately. Storage environment. 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. Do not place the IPG deeper than 4.0 cm (1.57 in) because the clinician programmer or patient controller may not communicate effectively with the IPG. Do not use excessive force to push the lead or sheath into the neural foramen as this may result in permanent or transient nerve damage. Removing components. Patient's visual ability to read the patient controller screen. The Prodigy MRI SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott's smallest implantable pulse generator (IPG). Advise patients to not use the patient controller when engaging in activities that might cause it to get wet, such as swimming or bathing. This system is contraindicated for patients who meet the following criteria: The following procedures are contraindicated for patients with a deep brain stimulation system. INDICATIONS FOR USE If the lead extensions are routed in a loop, the loop will increase the potential for electromagnetic interference (EMI). Read this section to gather important prescription and safety information. Sheath rotation. Patients should cautiously approach such devices and should request help to bypass them. 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. Infection. Placing the IPG. Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket. High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. The patient should be able and willing to use the patient controller and correctly interpret the icons and messages that appear on the screen. Advise patients to inform their healthcare professional that they cannot undergo the following procedures: Diathermy (short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy), Electroshock therapy and transcranial magnetic stimulation (TMS). 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.
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