If radiation therapy is required, the area over the implanted IPG should be shielded with lead. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. 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). Object Category Spinal Cord Stimulation Systems: St. Jude Medical. Bold New Spinal Cord Stimulation - Proclaim XR SCS System If two systems are implanted, ensure that at least 20 cm (8 in.) Low frequencies. Return all explanted generators to Abbott Medical for safe disposal. Links which take you out of Abbott worldwide websites are not under the control of Abbott, and Abbott is not responsible for the contents of any such site or any further links from such site. Please be aware that the website you have requested is intended for the residents of a particular country or countries, as noted on that site. All components listed must be implanted unless noted as "optional." This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. Surgical complications and adverse events may be more frequent and severe in patients with diabetes. Abbott recently received new FDA-approved labeling which expands MRI compatibility with the leads used on the Proclaim TM XR Spinal Cord Stimulation System. For more information about MR Conditional products, visit the Abbott Medical product information page at neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html. Return them to Abbott Medical for proper disposal. Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. Interference with other devices. This neurostimulation system is designed to deliver low-intensity electrical impulses to nerve structures. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. 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. communication equipment (such as microwave transmitters and high-power amateur transmitters). Keep programmers and controllers dry. Use extreme care to not damage the lead with the sharp point of the tunneling tool. Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient. Use extreme care when handling system components prior to implantation. Operation of machines, equipment, and vehicles. 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. 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. Abandoned leads and replacement leads. Deep brain stimulation complications include, but are not limited to, the following: Undesirable changes in stimulation related to cellular changes in tissue around the electrodes, changes in the electrode position, loose electrical connections, or lead fracture, Loss of therapeutic benefit as a result of change in electrode positions, loose electrical connections, or lead or extension fracture, Initial jolt or tingling during stimulation; jolting or shocking sensations, Lead fracture, migration, or dislodgement, Extension malfunction, fracture, or disconnect, Deep brain stimulation system failure or battery failure within the device, Deep brain stimulation system malfunction or dislodgement, Allergic or rejection response to implanted materials, Persistent pain, tightness, or redness at the incision sites or general pain, General erosion or local skin erosion over the IPG, Persistent pain, tightness, or discomfort around the implanted parts (e.g., along the extension path in the neck), Impaired wound healing (e.g., incision site drainage) or abscess formation, Additional neurosurgical procedure to manage one of the above complications or to replace a malfunctioning component, Stimulation-related complications or other complications, Worsening of motor impairment and Parkinsons disease symptoms including dyskinesia, rigidity, akinesia or bradykinesia, myoclonus, motor fluctuations, abnormal gait or incoordination, ataxia, tremor, and dysphasia, Paresis, asthenia, hemiplegia, or hemiparesis, Sensory disturbance or impairment including neuropathy, neuralgia, sensory deficit, headache, and hearing and visual disturbance, Speech or language impairment including, aphasia, dysphagia, dysarthria, and hypophonia, Cognitive impairment including attention deficit, confusion, disorientation, abnormal thinking, hallucinations, amnesia, delusions, dementia, inability to act or make decisions, psychic akinesia, long term memory impairment, psychiatric disturbances, depression, irritability or fatigue, mania or hypomania, psychosis, aggression, emotional lability, sleep disturbance, anxiety, apathy, drowsiness, alteration of mentation, postural instability and disequilibrium, Cardiac dysfunction (e.g., hypotension, heart rate changes, or syncope), Eye disorder including eye apraxia or blepharospasm, (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. 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. The severity of any surgical complication may be greater in patients with diabetes, particularly those with inadequate pre-operative glycemic control. To prevent unintended stimulation, do not modify the operating system in any way. Do not use surgical instruments to handle the lead. This damage could result in loss of therapy, requiring additional surgery for system replacement. If needed, return the equipment to Abbott Medical for service. The system is intended to be used with leads and associated extensions that are compatible with the system. Sheath insertion precaution. This neurostimulation system is contraindicated for patients who are. Especially consider the following additional factors when selecting patients: Level of available support from a caregiver. Implanting physicians or anesthesiologists should consult practice guidelines for the intraoperative management of patients with diabetes. Both the Intellis and Vanta SCS devices integrate SureScan MRI technology, providing MRI access anywhere in the body with normal operating mode power settings. 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. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. 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. Loss of coordination is a potential side effect of DBS therapy. Advise patients to not use their device when engaging in activities that might cause it to get wet, such as swimming or bathing. Patient's physical ability, as patients with higher degrees of motor impairment might have difficulty with the physical requirements of monitoring the device. Energy from diathermy can be transferred through the implanted system and can cause tissue damage at the location of the implanted electrodes, resulting in a severe injury or death. For less than 30 m (100 ft) of water or pressures below 4.0 ATA, durations of less than 60 minutes are recommended. Number of leads implanted. Ask patients with neurostimulators to shut off the device temporarily while the scan is performed. 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. These activities may cause lead movement, resulting in under stimulation or overstimulation for the patient. Changes in blood glucose levels in response to any adverse effect
NOTE: During intraoperative testing, Surgery mode must be turned off for the neurostimulation system to function correctly. Household appliances. Return all explanted components to Abbott Medical for safe disposal. 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). Return the explanted IPG to Abbott Medical. Package or component damage. Have the patient check the device for proper functioning, even if the device was turned off. Do not resterilize or reimplant an explanted system for any reason. 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. Storage environment. IMAGINE A FUTURE - cloud.neuroemail.abbott.com Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation. 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. Guidance and conditions for MRI safety with neuromodulation systems, neuromodulation.abbott/us/en/healthcare-professionals/mri-support.html, Upper buttock, low back, midline, flank or abdomen, Upper buttock, low back, flank, or abdomen, 6170 directional lead, 30 cm, 0.5-mm spacing, black, Fully implanted in the brain, routed under the scalp, 6010 Guardian cranial burr hole cover system, Fully implanted in the brain, routed under the scalp and connected to an extension, Head and neck, routed to the IPG on the same side of the body as the IPG, Lead-only systems, which consist of at least one implanted lead connected to a lead protection boot, as well as an optional cranial burr hole cover, Full systems, which consist of at least one implantable pulse generator (IPG), lead and extension, as well as an optional cranial burr hole cover. Removing components. Security, antitheft, and radiofrequency identification (RFID) devices. Activities requiring excessive twisting or stretching. Unilateral or bilateral stimulation of the internal globus pallidus (GPi) or the subthalamic nucleus (STN) for the management of intractable, chronic dystonia, including primary and secondary dystonia, for patients who are at least 7 years old. In rare cases, this can create a medical emergency. *Study subjects from the ACCURATE clinical study had failed to achieve adequate pain relief from at least two prior pharmacologic treatments from at least two different drug classes and continued their pharmacologic therapy during the clinical study. Do not use excessive pressure when injecting through the sheath. Unwanted changes in stimulation may include a jolting or shocking feeling. 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. External defibrillators. Implantation of multiple leads. 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 at medical.abbott/manuals). Securing the anchor. The safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established. Diathermy is further prohibited because it may also damage the neurostimulation system components. 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. If gas fumes or vapors catch fire, it could cause severe burns, injury, or death. Advise patients to contact their healthcare provider as soon as possible if they suspect their device is not functioning properly after a CT scan. Electrocardiograms. Consider seeking surgical advice if you cannot easily remove a lead. Sheath insertion warning. High-output ultrasonics and lithotripsy. 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. If they must go through a gate or doorway containing this type of device, patients should turn off their generator and proceed with caution, being sure to move through the device quickly. Do not use the application if the operating system is compromised (i.e., jailbroken). Equipment is not serviceable by the customer. Damage to the system may not be immediately detectable. Patients should cautiously approach such devices and should request help to bypass them. Radiofrequency or microwave ablation. The device should be turned off and the doctor contacted if this occurs. Therapeutic radiation. Patient's mental capacity, as patients with cognitive impairment or those prone to developing dementia would likely have difficulty performing device-related tasks without assistance. Advance the needle and guidewire slowly. Damage to the system may not be immediately detectable. Use fluoroscopy and extreme care when inserting, advancing, or manipulating the guidewire or lead in the epidural space to minimize the risk of a dural tear. Nonadjacent leads can possibly create a conduit for stray electromagnetic energy that could cause the patient unwanted stimulation. Mobile phones. Electrosurgery. 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. New onset or worsening depression, which may be temporary or permanent, is a risk that has been reported with DBS therapy. Advise patients to not use the patient controller when engaging in activities that might cause it to get wet, such as swimming or bathing. Electromagnetic interference (EMI). 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. Confirm that no adverse conditions to MR scanning are present. Implanted cardiac systems. 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. Before diving or using a hyperbaric chamber, patients should contact their physician to discuss the effects of high pressure on their implanted system. The safety and efficacy of implantation of leads implanted above the T10 vertebral level have not been evaluated. Failure to provide strain relief may result in lead migration requiring a revision procedure. Schu S, Gulve A, ElDabe S, et al. FDA approves new MRI compatibility for Abbott's Proclaim spinal cord Read this section to gather important prescription and safety information. Multiple leads. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system: Other active implanted devices. After defibrillation, confirm the neurostimulation system is still working. Do not use short-wave diathermy, microwave diathermy, or therapeutic ultrasound diathermy (all now referred to as diathermy) on patients implanted with a neurostimulation system. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient controller. Package or component damage. Advise your patient to avoid manipulating the implanted system components (e.g., the neurostimulator, the burr hole site). The tip of the sheath may whip around and could cause harm to the patient. Patient's visual ability to read the patient controller screen. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. The safety and efficacy for the treatment of patients who have back pain as the greatest region of pain have not been evaluated. If a system does not meet the MR Conditional requirements, consider it MR Unsafe. Some of this systems electronic equipment, such as the programmer and controller, can radiate radiofrequency (RF) energy that may interfere with other electronic devices, including other active implanted devices. Security, antitheft, and radiofrequency identification (RFID) devices. Follow proper infection control procedures. Patients who are implanted with nonadjacent multiple leads and patients who are sensitive to low stimulation thresholds may experience a momentary increase in their perceived stimulation, which some patients have described as uncomfortable or jolting. Lead inspection. 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). The BurstDR stimulation mode has not been evaluated for effectiveness in the diabetic peripheral neuropathy (DPN) population. Case damage. 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. 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. Spinal cord stimulation of the dorsal root ganglion for groin pain-a retrospective review. 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 this reason, programming at frequencies less than 30 Hz is not recommended. 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. Long-term safety and effectiveness. 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. Therapeutic radiation. If two systems are implanted, ensure that at least 20 cm (8 in.) In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. High-output ultrasonics and lithotripsy. Lead damage from tools. Implantation of two systems. Stimulation effectiveness has been established for one year. Operation of machines, equipment, and vehicles. 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. Inserting the anchor. Consumer goods and electronic devices. 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. Devices with one-hour recharge per day. Needle insertion. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training.