For adverse effects observed in SCS clinical studies, refer to the clinical summaries manual for SCS systems. Schu S, Gulve A, ElDabe S, et al. and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). 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). The effect of other implanted devices, including deep brain stimulators, peripheral nerve stimulators, implanted drug delivery pumps, and cochlear implants on the neurostimulation system are unknown. If patients feel that the TENS device may be interfering with the neurostimulator, patients should discontinue using the TENS device until they talk with their physician. 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. Device modification. Pediatric use. Implantation of multiple leads. 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. To correct the effects of typical interference, keep wireless communication equipment at least 15 cm (6 in) from the IPG. The following procedures are contraindicated for patients that have been implanted with this device: Diathermy therapy. For complete MRI guidance, parameters and cautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. Failure to do so may cause harm to the patient such as damage to the dura. Loss of coordination is a potential side effect of DBS therapy. 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. The lead-extension connector should not be placed in the soft tissues of the neck due to an increased incidence of lead fracture. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Diathermy is further prohibited because it may also damage the neurostimulation system components. 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. It's small, discreet and available with Abbott's proprietary BurstDR stimulation, a new technology that's clinically proven to . We offer products that are MR Conditional for spinal cord stimulation (SCS) and dorsal root ganglion (DRG) therapy. If multiple leads or extensions are implanted, the leads and extensions should be routed in close proximity. Transcranial magnetic stimulation (TMS) and electroconvulsive therapy (ECT). Suicidal ideation, suicide attempts, and suicide are events that have also been reported. Failure to do so can damage or cut the lead or sheath. Introduction: Spinal cord stimulation is becoming an increasingly used modality for the treatment of chronic pain. If gas fumes or vapors catch fire, it could cause severe burns, injury, or death. Patients should be advised to avoid carrying mobile phones in their shirt pocket or otherwise placing them directly over the deep brain stimulation system components. 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. Application modification. Unauthorized changes to stimulation parameters. If they must go through or near a gate or doorway containing this type of device, patients should move quickly and then check their IPG to determine if it is turned on or off. 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. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Lead movement. 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. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. Patients should not operate potentially dangerous machinery, power tools, or vehicles or engage in any activity that could be unsafe if their symptoms were to unexpectedly return. 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. Neurostimulation systems have materials that come in contact or may come in contact with tissue. Unwanted changes in stimulation may include a jolting or shocking feeling. If a system does not meet the MR Conditional requirements, consider it MR Unsafe. 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. Stimulation Modes. Do not bring the suture needle in contact with an IPG, lead, or extension, or the component may be damaged. Needle positioning. Use caution when positioning the needle to avoid unintended injury to surrounding anatomical structures. Consumer goods and electronic devices. Advise patients about adverse effects. Electrocardiograms. Neurosurgery Pain Management Orthopaedic Surgery Surgeon training. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Control of the patient controller. Do not crush, puncture, or burn the generator because explosion or fire may result. Patient's age, as very young or very old patients may have difficulty performing required monitoring of the device. Bending the sheath. Implantation of two systems. Household appliances. 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. 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. Make the Bold Choice Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. Restricted areas. Security, antitheft, and radiofrequency identification (RFID) devices. Follow proper infection control procedures. If the operating field is bloody, wipe gloves, lead, stylet, and sheath before handling the lead. 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. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. **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. Device modification. Exit Surgery mode during intraoperative testing and after the procedure is completed. 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. 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). Security, antitheft, and radiofrequency identification (RFID) devices. 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. Set the electrosurgery device to the lowest possible energy setting. Sheath retraction. Stimulation frequencies at less than 30 Hz may cause tremor to be driven (meaning that tremor occurs at the same frequency as the programmed frequency). Lead handling. 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. Unlike other SCS systems, the ProclaimXR SCS system is recharge free. If resistance is encountered, pull the needle out of the epidural space and then remove the sheath. The long-term safety and effectiveness of this neurostimulation system has not been established beyond 5 years. Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. Component handling. Poor surgical risks. 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). 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. Removing components. Do not over-manipulate the sheath and lead system as this may result in trauma within the epidural space. Damage to the system may not be immediately detectable. Poor surgical risks. Surgical complications and adverse events may be more frequent and severe in patients with diabetes. away from the generator and avoid placing any smart device in a pocket near the generator. To prevent injury or damage to the system, do not modify the equipment. If a patient is concerned about a smart device interacting with their neurostimulation system, consider disabling magnet mode. Postoperatively, actively monitor patients for new or worsening symptoms of depression, suicidal thoughts or behaviors, or changes in mood or impulse control. Scanning under different conditions may cause device malfunction, severe patient injury, or death. Care and handling of components. High-output ultrasonics and lithotripsy. Cremation. Before opening any sterile package, verify the kit model number, that the kit is within its expiration (use-before) date, and that the packaging has not been damaged or compromised in any way. Stimulation effectiveness. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. System testing. Do not use surgical instruments to handle the lead. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. Electrosurgery. Use extreme care when handling system components. Before diving or using a hyperbaric chamber, patients should discuss the effects of high pressure with their physician. Confirm that the neurostimulation system is functioning correctly during the implant procedure, before closing the neurostimulator pocket, and after the implant procedure. External defibrillators. Abbott is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement of the linked site by Abbott. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. 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. Operating the device near gas fumes or vapors could cause them to catch fire. Do not use the system if the use-before date has expired. Patients who failed to receive effective pain relief during trial stimulation are contraindicated to process to the permanent implant procedure. 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. Advancing components. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. The following additional considerations should be made for patients with diabetes: A pre-operative risk assessment should be performed for patients with diabetes who are at high risk for ischemic heart disease, those with autonomic neuropathy or renal failure, and patients with a Hemoglobin A1C (HbA1c) 8% (64 mmol/mol). Magnetic resonance imaging (MRI). Batteries can explode, leak, or melt if disassembled, shorted (when battery connections contact metal), or exposed to high temperature or fire. Follow proper infection control procedures. The BurstDR stimulation mode has not been evaluated for effectiveness in the diabetic peripheral neuropathy (DPN) population. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system. If needed, return the equipment to Abbott Medical for service. radiofrequency identification (RFID) devices. Failure to push the short end of the soft tissue anchor into the ligament or fascia may result in lead migration and a procedure to revise the lead location. Infection. 21 CR 801.109(b) The label of the device, other than surgical instruments, bears: (1) The symbol statement Rx only or only or the statement Caution: Federal law restricts this device to sale by or on the order of a ___, the blank to be filled with the word physician, dentist, veterinarian, or with the descriptive designation of any other practitioner licensed by the law of the State in which the practitioner practices to use or order the use of the device; and. 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. Component disposal. Therapeutic magnets. Stimulation at high outputs may cause unpleasant sensations or motor disturbances, or render the patient incapable of controlling the stimulator. PATIENTS The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. Infection. Skydiving, skiing, or hiking in the mountains. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. If radiation therapy is required, the area over the implanted IPG should be shielded with lead. For complete and comprehensive MRI support, parameters, and precautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. Higher amplitudes and wider pulse widths may indicate a system problem or a suboptimal lead placement. Consumer goods and electronic devices. 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), high-voltage power lines, radiofrequency identification (RFID) devices, and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy).