Restricted areas. In addition to those risks commonly associated with surgery, the following risks are associated with implanting or using this neurostimulation system: Unpleasant sensations or motor disturbances, including involuntary movement, caused by stimulation at high outputs; if either occurs, turn off your IPG immediately, 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, Persistent pain at the electrode or IPG site, Seroma (mass or swelling) at the IPG site. Scanning under different conditions may cause device malfunction, severe patient injury, or death. Up to two IPGs, leads, extensions, and burr hole covers may be implanted. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. 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. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) six to eight weeks after implantation of a neurostimulation system. commercial electrical equipment (such as arc welders and induction furnaces). This means you can get hassle-free pain relief with a battery that lasts up to 10 years at low-dose settings** without ever needing to charge the system. 2013;16(5):471-482. Securing the anchor. Mobile phones. Minimize X-ray exposure to the implanted or externally worn electronic medical device by using the lowest possible X-ray tube current consistent with obtaining the required image quality and by making sure that the X-ray beam does not dwell over the device for more than a few seconds. Diathermy is further prohibited because it may also damage the neurostimulation system components. Pressures below 30 m (100 ft) of water (or above 4.0 ATA) could damage the neurostimulation system. 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. In some environments, the use of wireless functions (for example, Bluetooth wireless technology) may be restricted. Transcutaneous electrical nerve stimulation (TENS). 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. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient controller. This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. The website that you have requested also may not be optimized for your screen size. Patient's physical ability, as patients with higher degrees of motor impairment might have difficulty with the physical requirements of monitoring the device. Caution patients to not make unauthorized changes to physician-established stimulation parameters. Generator disposal. This damage could result in loss of therapy, requiring additional surgery for system replacement. Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment. 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. Follow proper infection control procedures. Do not place TENS electrodes so that the TENS current passes over any part of the neurostimulation system. For less than 30 m (100 ft) of water or pressures below 4.0 ATA, durations of less than 60 minutes are recommended. Abandoned leads and replacement leads. The Proclaim XR SCS System is an implantable spinal cord stimulation device designed to allow patients to attain relief from chronic pain of the trunk and limbs. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. 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. 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. Instruct patients to avoid scuba diving and entering hyperbaric chambers above 1.5 atmospheres absolute (ATA) because these activities might damage the neurostimulation system. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems. Perception of higher levels of stimulation has been described by some patients as uncomfortable, painful, or jolting. In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. Stylet handling. Inaccurate ECG results may lead to inappropriate treatment of the patient. To prevent unintended stimulation, do not modify the operating system in any way. Radiofrequency or microwave ablation. Do not handle the generator if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. As a result, the site may contain information on pharmaceuticals, medical devices and other products or uses of those products that are not approved in other countries or regions. Needle positioning. Security, antitheft, and radiofrequency identification (RFID) devices. 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. External defibrillators. For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual. Excessive lead migration may require reoperation to replace the leads. External defibrillators. Placing the IPG. 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. Interference with wireless equipment. While charging the generator, patients may perceive an increase in temperature at the generator site. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system: Other active implanted devices. Therapeutic radiation. Follow proper infection control procedures. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training. Some models of this system are Magnetic Resonance (MR) Conditional, and patients with these devices may be scanned safely with magnetic resonance imaging (MRI) when the conditions for safe scanning are met. Cremation. Neurosurgery Pain Management Orthopaedic Surgery Note: Patients with diabetes may have increased risks of infection, problems healing around the surgical site, and complications common to any surgical procedure. If the operating field is bloody, wipe gloves, lead, stylet, and sheath before handling the lead. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. Monitor the patients blood glucose levels in the perioperative period and instruct the patient to continue to monitor glucose levels as they may fluctuate as a response to surgery or to complications. Do not resterilize or reimplant an explanted system for any reason. Case damage. It is extremely important to select patients appropriately for neurostimulation. The safety and efficacy of the implantation of greater than four leads have not been evaluated. Do not use the application if the operating system is compromised (i.e., jailbroken). Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for six to eight weeks after implantation of a neurostimulation system. 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. Operation of machines, equipment, and vehicles. The abrupt cessation of stimulation for any reason will probably cause disease symptoms to return. Falling and other traumatic accidents can damage shallowly implanted components such as the leads and extensions. Stabilizing the lead during insertion. Conscious sedation can cause side effects such as systemic toxicity, or cardiovascular or pulmonary problems. Interference with other devices. Such restrictions may apply aboard airplanes, near explosives, or in hazardous locations. Lead movement. Patients should be advised to not use therapeutic magnets. 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. During implant procedures, if electrosurgery devices must be used, take the following actions: Complete any electrosurgery procedures before connecting the leads or extensions to the neurostimulator. Neurostimulation should not be used on patients who are poor surgical candidates. 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. To prevent unintended stimulation, do not modify the operating system in any way. Diathermy therapy. High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. The long-term effectiveness of dorsal root ganglion (DRG) stimulation has not been documented, and not all patients realize the long-term benefits from DRG stimulation. 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. 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. Electromagnetic interference (EMI). Implantation of this neurostimulation system is contraindicated for the following: Patients for whom test stimulation is unsuccessful. The clinician programmer and patient controller are not waterproof. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. between lead ends is recommended); Verify that the neurostimulation system is not interfering with the function of the implanted cardiac system; and. 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. To prevent injury or damage to the system, do not modify the equipment. Exposure to body fluids or saline. Removing each item in slow movements while holding the remaining components in place will assist this process. For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. Use care when reinserting a stylet. 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. Security, antitheft, and radiofrequency identification (RFID) devices. 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. High altitudes should not affect the neurostimulator; however, the patient should consider the movements involved in any planned activity and take precautions to avoid putting undue stress on the implanted system. Abbott (NYSE:ABT) announced today that it received FDA approval for new magnetic resonance imaging (MRI) compatibility for the Proclaim system. Clinician training. However, current data shows that most patients using BurstDR stimulation therapy do not experience paresthesia. If the programming of stimulation parameters exceeds the charge density limit of 30 C/cm2, a screen will appear warning you that the charge density is too high. Lead movement. The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system. In rare cases, this can create a medical emergency. 71376 MAT-2006974 v2.0 | Item approved for U.S. use only. Always perform removal of implanted components with the patient conscious and able to give feedback. 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. Preventing infection. 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. Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the management of disabling tremor. Keep dry to avoid damage. Patients should exercise reasonable caution when bathing. 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. 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. Advise patients to not use their device when engaging in activities that might cause it to get wet, such as swimming or bathing. Keep the current paths from the electrosurgery device as far from the neurostimulation system as possible. If a patient experiences new or worsening depression or suicidal ideation, manage these symptoms appropriately. The use of high-output devices, such as an electrohydraulic lithotripter, may cause damage to the electronic circuitry of an implanted IPG. Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura. If the sheath has been kinked during delivery, slowly retract through the needle with the curve facing the same direction as the bevel.

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