Suicidal ideation, suicide attempts, and suicide are events that have also been reported. 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. Equipment is not serviceable by the customer. Use care when reinserting a stylet. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. Lead movement. For more information about MR Conditional neurostimulation components and systems, including equipment settings, scanning procedures, and a complete listing of conditionally approved components, refer to the MRI procedures clinician's manual for neurostimulation systems(available online atmedical.abbott/manuals). Educate patients and caregivers about these potential risks prior to implantation, and be sure that they know about the importance of ongoing support and follow-up, including when to contact their health care provider. To prevent injury or damage to the system, do not modify the equipment. Implanted systems with non-Abbott leads have not been evaluated for safety while scuba diving or in hyperbaric chambers. 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. For more information about MR Conditional neurostimulation components and systems, including equipment settings, scanning procedures, and a complete listing of conditionally approved components, refer to the MRI procedures clinician's manual for neurostimulation systems (available online atmedical.abbott/manuals).
Proclaim DRG System | Abbott 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. In patients who have areas of increased sensitivity to heat, consider placing the implant where the patient has normal sensation. Use extreme care when handling system components. Therapeutic magnets (e.g., magnets used in pillows, mattress pads, back belts, knee braces, wrist bands, and insoles) may unintentionally cause the neurostimulation system to turn on or off. Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the management of disabling tremor. Anchoring leads. External defibrillators. Patients will receive an identification card to carry with them that will inform emergency medical personnel of their implanted system. Poor surgical risks. Remove the stylet from the lead only when satisfied with lead placement. 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. To correct the effects of typical interference, keep wireless communication equipment at least 15 cm (6 in) from the IPG. Case damage. Mobile phones. External defibrillation can cause induced currents in the leadextension portion of the neurostimulation system. The IPG should be placed into the pocket, at a depth not to exceed 4.0 cm (1.57 in), with the logo side facing toward the skin surface. Poor surgical risks. Explosive and flammable gasses. Avoid excessive stimulation. Scuba diving or hyperbaric chambers. 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. Confirm implant locations and scan requirements for the patients system. Scuba diving or hyperbaric chambers. 72784 MAT-2215217 v2.0 | Item approved for U.S. use only. Complete any electrosurgery before connecting the leads or extensions to the neurostimulator. Other neurostimulators may restrict the allowed MRI power or scan location, preventing imaging on your shoulders or vital organs in your torso. Consider seeking surgical advice if you cannot easily remove a lead. Security, antitheft, and radiofrequency identification (RFID) devices. Before beginning a CT scan, the operator should use CT scout views to determine if implanted or externally worn electronic medical devices are present and if so, their location relative to the programmed scan range. Operation of machines, equipment, and vehicles. High stimulation outputs. The equipment is not serviceable by the customer. Advance the needle and guidewire slowly. Consumer goods and electronic devices. 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. Instruct patients to contact their physician if they experience any adverse effects, such as unusual pain or discomfort during stimulation and swelling, redness, tenderness, or pain around implanted components. Bending the sheath. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system. A recharge-by date is printed on the packaging. Additional Disadvantages.
Proclaim Plus: The Next Burst in Chronic Pain Care | Abbott Newsroom Proclaim Plus Spinal Column Stimulation (SCS) System PRESCRIPTION AND SAFETY INFORMATION Read this section to gather important prescription and safety information. Needle positioning. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Keep them dry to avoid damage. Patients should not use this neurostimulation system if they are pregnant or nursing. Electrical pulses from a neurostimulation system may interact with the sensing operation of an implanted cardiac system, causing the cardiac system to respond inappropriately. 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). Needle insertion. For CT procedures in which the medical device is in or immediately adjacent to the programmed scan range, the operator should: If practical, try to move external devices out of the scan range. Package or component damage. 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. 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. 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. Important note: For CT procedures that require scanning over the medical device continuously for more than a few seconds, as with CT perfusion or interventional exams, attending staff should be ready to take emergency measures to treat adverse reactions if they occur. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Household appliances that contain magnets (e.g., refrigerators, freezers, inductive cooktops, stereo speakers, mobile telephones, cordless telephones, standard wired telephones, AM/FM radios, and some power tools) may unintentionally cause the neurostimulation system to turn on or turn off. Storage environment. To ensure correct operation, always test the system during the implant procedure, before closing the neurostimulator pocket, and before the patient leaves the surgery suite. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. This neurostimulation 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. Electromagnetic interference (EMI). External defibrillation can cause induced currents in the lead-extension portion of the neurostimulation system. Unauthorized changes to stimulation parameters. Handle the device with care. Dural puncture can occur if needle or guidewire is advanced aggressively once loss of resistance is achieved. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief. 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.). separates the implanted generators to minimize unintended interaction with other system components. Do not implant a device if the sterile package, the device, or any device components show signs of damage, tampering, or if the sterile seal is ruptured, or contamination is suspected for any reason. Care and handling of components. While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. Securing the IPG. Confirm the neurostimulation system is functioning correctly after the procedure. Do not bring the suture needle in contact with an IPG, lead, or extension, or the component may be damaged.
Abbott's Proclaim XR Spinal Cord Stimulation System Now Offers Abbott's Proclaim XR Spinal Cord Stimulation System Now Offers 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. For complete MRI guidance, parameters and cautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. Failure to provide strain relief may result in lead migration requiring a revision procedure. The safety and efficacy of implantation of leads implanted above the T10 vertebral level have not been evaluated. Return any suspect components to Abbott Medical for evaluation. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Back pain. 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.