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. Store components and their packaging where they will not come in contact with liquids of any kind. Lead movement. The use of components not approved for use by Abbott Medical with this system may result in damage to the system and increased risk to the patient. Skydiving, skiing, or hiking in the mountains. 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. Do not crush, puncture, or burn the IPG because explosion or fire may result. Pediatric use. 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. Use appropriate sterile technique when implanting leads and the IPG. 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 prevent unintended stimulation, do not modify the operating system in any way. The operation of these devices could cause them to ignite, causing severe burns, injury, or death. Abbott's neurostimulation therapies are designed to alter those signals as they travel to the brain, and minimize how you perceive pain.3 PROVEN SAFE AND EFFECTIVEWITH BENEFITS BEYOND PAIN RELIEF2, 4 One of the advantages of neurostimulation is that you can try the therapy using a temporary system before committing to an implanted system. Therapeutic radiation. Return any suspect components to Abbott Medical for evaluation. and some medical procedures (such as therapeutic radiation and electromagnetic lithotripsy). Recharge-by date. Operation of machines, equipment, and vehicles. Stimulation Modes. Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. Use caution when securing the soft tissue anchor because damage to the anchor or lead can occur and result in failure of the system. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. Loss of coordination is a potential side effect of DBS therapy. 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. Electrical medical treatment. The clinician programmer and patient controllers are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. This includes oxygen-enriched environments such as hyperbaric chambers. Implanted cardiac systems. Patient's visual ability to read the patient controller screen. Placing the IPG. 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. 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. 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. Do not bend, kink, or stretch the lead body, sheaths, or other components as this may result in damage to the component and poor function. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. After defibrillation, confirm the neurostimulation system is still working. Set the electrosurgery device to the lowest possible energy setting. For less than 30 m (100 ft) of water or pressures below 4.0 ATA, durations of less than 60 minutes are recommended. 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 not use their devices when engaging in activities that might cause them to get wet, such as swimming or bathing. Conscious sedation during removal. Damage to the system may not be immediately detectable. If unpleasant sensations occur, the device should be turned off immediately using the patient magnet. Patient selection. When using a contralateral approach, advance the needle slowly into the epidural space and take caution as it enters. Do not use the system if the use-before date has expired. 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. Removing components. 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. If two systems are implanted, ensure that at least 20 cm (8 in) separates the implanted IPGs to minimize unintended interaction with other system components. Clinician training. 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 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. Coagulopathies. Patients should be advised to not use therapeutic magnets. 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. 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. Operating the device near gas fumes or vapors could cause them to catch fire. Always perform removal with the patient conscious and able to give feedback. Storage environment. We know that MRI scans are an important and trusted visualization tooland thats why weve designed our devices and technologies to fit as seamlessly as possible into this critical step in your diagnostic workflow. Thorough psychiatric screening should be performed. Handle the device with care. Security, antitheft, and radiofrequency identification (RFID) devices. If radiation therapy is required, the area over the implanted generator should be shielded with lead. Regardless if the device is deactivated, take care to monitor the device for proper function during and after treatment. For complete MRI guidance, parameters and cautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. Inaccurate ECG results may lead to inappropriate treatment of the patient. 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. Exit Surgery mode during intraoperative testing and after the procedure is completed. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. away from the generator and avoid placing any smart device in a pocket near the generator. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. 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. If unpleasant sensations occur, the device should be turned off immediately. Do not use the clinician programmer or patient controller in an environment where explosive or flammable gas fumes or vapors are present. 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. If the sheath has been kinked during delivery, slowly retract through the needle with the curve facing the same direction as the bevel. Have the patient check the device for proper functioning, even if the device was turned off. High-output ultrasonics and lithotripsy. Set the electrosurgery device to the lowest possible energy setting. If multiple leads are implanted, leads and extensions should be routed in close proximity. The IPG should be explanted before cremation because the IPG could explode. Patients should cautiously approach such devices and should request help to bypass them. 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). Conscious sedation. Care and handling of components. 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. If the sheath is not responding to rotation, do not rotate the steering wing out of plane from the curve of the sheath more than 90 degrees. 72750 MAT-2215018 v2.0 | Item approved for U.S. use only. 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). 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. 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. 2013;16(5):471-482. Programmer use. 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. Electromagnetic interference (EMI). Patients should not be dependent on drugs and should be able to operate the neurostimulation system. Infection. 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 any suspect components to Abbott Medical for evaluation. Interference with wireless equipment. Emergency procedures. To correct the effects of typical interference, keep wireless communication equipment at least 15 cm (6 in) from the IPG. Patient selection. Implanted systems with non-Abbott leads have not been evaluated for safety while scuba diving or in hyperbaric chambers. Do not crush, puncture, or burn the IPG because explosion or fire may result. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. 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. 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. If a patient experiences new or worsening depression or suicidal ideation, manage these symptoms appropriately. After any surgery, check the neurostimulation system for the following: Check the neurostimulator to ensure Surgery mode has been turned off, even if Surgery mode was not turned on at the beginning or during the procedure. If interference occurs, try holding the phone to the other ear or turning off the phone. In rare cases, this can create a medical emergency. Failure to do so may result in difficulty delivering the lead. Implantation of multiple leads. Generator disposal. Other active implantable devices. For complete guidance, directions, and cautions on MRI safety with a specific device, please review the MRI procedure clinician's manual. Approved models and implant locations for an MR Conditional full system, *The IPG port plug associated with these models is also an MR Conditional component. Safety has not been established for radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system. Unilateral or bilateral stimulation of the ventral intermediate nucleus (VIM) of the thalamus for the suppression of disabling upper extremity tremor in adult essential tremor patients whose tremor is not adequately controlled by medications and where the tremor constitutes a significant functional disability. The safety and efficacy of the implantation of greater than four leads have not been evaluated. During the implant procedure, if an electrosurgery device must be used, take the following actions:. To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. Patients should not dive below 30 m (100 ft) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. Do not bend, kink, or use surgical instruments on the stylet, as this may damage it. After defibrillation, confirm the neurostimulation system is still working. If the operating field is bloody, wipe gloves, lead, stylet, and sheath before handling the lead. If lithotripsy must be used, do not focus the energy near the generator. Do not insert the sheath into the epidural space without the lead or guidewire inserted, as this may cause injury to the dura. 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). Do not bend the sheath without the lead inside the sheath, as this will permanently kink it and make it difficult to deploy the lead. This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. Sheath insertion precaution. If resistance is encountered, pull the needle out of the epidural space and then remove the sheath. 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. Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinsons disease. 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. IPGs contain batteries as well as other potentially hazardous materials. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. Store components and their packaging where they will not come in contact with liquids of any kind. Conditional 5. Return all explanted generators to Abbott Medical for safe disposal. 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. Diathermy is further prohibited because it may also damage the neurostimulation system components. Charge density can be reduced by lowering the stimulation amplitude or pulse width. Patients should cautiously approach such devices and should request help to bypass them. Patients who are unable to properly operate the system. Instruct patients to use their neurostimulation system only after an authorized clinician has programmed the device and has trained the patient how to control stimulation and safely use the system. Safety has not been established for TMS or ECT in patients who have an implanted neurostimulation system. Confirm implant locations and scan requirements for the patients system. 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. Therapeutic radiation. The Eterna Spinal Cord Stimulation (SCS) System is designed to deliver low-intensity electrical impulses to nerve structures. Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation. 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. Abbott's Proclaim XR Spinal Cord Stimulation System Now Offers Expanded MRI Compatibility in U.S. - New U.S. FDA-approved labeling lifts restrictions on 60-centimeter Octrode leads,. If stimulation is not turned off, the patient may experience a momentary increase in stimulation, which may be uncomfortable. 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. 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. Storage environment. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). 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. Clinician training. Precision Spectra Spinal Cord Stimulator System Innovation Focused on Pain Relief Designed for more coverage, more flexibility, and advanced control, the Precision Spectra SCS System is engineered to provide more pain relief to a broader spectrum of patients. Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off.
abbott proclaim spinal cord stimulator mri safety