If the neurostimulator is on during an ECG, the ECG recording may be adversely affected, resulting in inaccurate ECG results. For more information, see the clinician programmer manual. Security, antitheft, and radiofrequency identification (RFID) devices. If the packaging has been compromised, the device is beyond its expiration date, or the sterile package or device show signs of damage, do not use the device as it may be compromised and could cause harm to the patient. Implant heating. External defibrillation can cause induced currents in the lead-extension portion of the neurostimulation system. Package or component damage. 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. Inaccurate ECG results may lead to inappropriate treatment of the patient. To correct the effects of typical interference, keep wireless communication equipment at least 15 cm (6 in) from the IPG. Keep them dry to avoid damage. 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. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. 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. 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. Component disposal. Infection. Use extreme care to not damage the lead with the sharp point of the tunneling tool. Radiofrequency or microwave ablation. The effect of mobile phones on deep brain stimulation is unknown. For more information about MR Conditional deep brain stimulation (DBS) 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 DBS systems(available online atmedical.abbott/manuals). Lead movement. Providing strain relief. 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. The patient must be awake and conversant during the procedure to minimize the likelihood of nerve damage. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Magnetic resonance imaging (MRI). Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Allow only authorized use of the clinician programmer to avoid any programming changes that may injure a patient. Only apply software updates that are published directly by Abbott Medical. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. 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.). Case damage. Induced electrical currents may cause heating, especially at the lead electrode site, resulting in tissue damage. Surgical advice for removal. Inserting the anchor. IPGs contain batteries as well as other potentially hazardous materials. 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. Avoid placing equipment components directly over other electronic devices. External defibrillators. 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. away from the generator and avoid placing any smart device in a pocket near the generator. 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 patient must be instructed to not rub or exert pressure on implanted components through the skin as this may cause lead dislodgement leading to stimulation at the implant site, IPG inversion leading to the inability to communicate with the device, or skin erosion that can lead to another surgical procedure or possible infection. Proclaim XR SCS System with BurstDR stimulation offers you superior* pain relief 1. Output power below 80 W is recommended for all activations. For more information about setting the magnet mode, refer to the clinician programmer manual or contact Technical Support. Patients with implanted Abbott leads should avoid scuba diving in more than 30 m (100 ft) of water or entering hyperbaric chambers above 4.0 atmospheres absolute (ATA) for any length of time, as this may damage the neurostimulation system. If multiple leads or extensions are implanted, the leads and extensions should be routed in close proximity. External defibrillation can cause induced currents in the leadextension portion of the neurostimulation system. Return any suspect components to Abbott Medical for evaluation. 72188 MAT-2214515 v1.0 | Item approved for U.S. use only. For this reason, programming at frequencies less than 30 Hz is not recommended. Return all explanted components to Abbott Medical for safe disposal. Patient training. Failure to do so may result in difficulty delivering the lead. 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. 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. Control of the patient controller. Advise patients about adverse effects. The implanted components of this neurostimulation system are intended for a single use only. Surgeon training. 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. Radiofrequency or microwave ablation. Prior to connection, exposure of the metal contacts, such as those on the connection end of a lead or extension, to body fluids or saline can lead to corrosion. This can result in component damage, lead dislodgement, skin erosion, or stimulation at the implant site. Electromagnetic interference (EMI). Implantation of two systems. Do not handle the generator if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. 71409MAT-2116350 v4.0 | Item approved for U.S. use only. 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. Application modification. Do not use a clinician programmer or patient controller around explosive or flammable gas fumes or vapors. Interference with wireless equipment. Stylet handling. Use caution when positioning the needle to avoid unintended injury to surrounding anatomical structures. Patients should be advised to not use therapeutic magnets. To prevent unintended stimulation, do not modify the operating system in any way. Loss of coordination is a potential side effect of DBS therapy. Mobile phones. Instruct patients to designate a representative (family member or close friend) to notify any emergency medical personnel of their implanted neurostimulation system if emergency care is required. In some environments, the use of wireless functions (e.g., Bluetooth wireless technology) may be restricted. The device should be turned off and the doctor contacted if this occurs. Explosive and flammable gasses. Electrical medical treatment. Failure to do so can damage or cut the lead or sheath. Abbott's Prodigy, Proclaim, and Proclaim XR SCS Systems are used to help manage chronic, intractable pain of the trunk and/or limbs, including one-sided or two-sided pain associated with the . Placement of lead connection in neck. Stimulation in unwanted places (such as radicular stimulation of the chest wall), Lead migration, causing changes in stimulation or reduced pain relief, Epidural hemorrhage, hematoma, infection, spinal cord compression, or paralysis from placement of a lead in the epidural space, Paralysis, weakness, clumsiness, numbness, or pain below the level of the implant, Persistent pain at the electrode or generator site, Seroma (mass or swelling) at the generator site, Allergic or rejection response to implant materials, Implant migration or skin erosion around the implant. 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. The use of high-output devices, such as an electrohydraulic lithotriptor, may damage the electronic circuitry of an implanted generator. Recharge-by date. High stimulation outputs and charge density limits. 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. If lithotripsy must be used, do not focus the energy near the IPG. System testing. To correct the effect of interference with other devices, turn off the equipment or increase the distance between the equipment and the device being affected. 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. Using surgical instruments. Return all explanted IPGs to Abbott Medical for safe disposal. The severity of any surgical complication may be greater in patients with diabetes, particularly those with inadequate pre-operative glycemic control. Unwanted changes in stimulation may include a jolting or shocking feeling. Return all explanted components to Abbott Medical for safe disposal. After CT scanning directly over the implanted or externally worn electronic medical device: Have the patient turn the device back on if it had been turned off prior to scanning. Stabilizing the lead during insertion. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or render the patient incapable of controlling the generator. Set the electrosurgery device to the lowest possible energy setting. Consider seeking surgical advice if you cannot easily remove a lead. Follow proper infection control procedures. Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation. 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. Failure to appropriately anchor the lead may cause lead migration, motor activation, or painful stimulation. FDA's expanded . Such restrictions may apply aboard airplanes, in hospitals, near explosives, or in hazardous locations. Unilateral or bilateral stimulation of the thalamus, internal globus pallidus (GPi), or subthalamic nucleus (STN) in patients with levodopa-responsive Parkinsons disease. Do not over-manipulate the sheath and lead system as this may result in trauma within the epidural space. These activities include but are not limited to climbing ladders and operating potentially dangerous machinery, power tools, and vehicles. If needed, return the equipment to Abbott Medical for service. Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. If two systems are implanted, ensure that at least 20 cm (8 in.) To avoid harming the patient or damaging the neurostimulation system, do not use monopolar electrosurgery devices on patients with implanted neurostimulation systems. 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. 74373 MAT-2300644 v2.0 | Item approved for U.S. use only. Handle the programmers and controllers with care. Always be aware of the needle tip position. If unpleasant sensations occur, the device should be turned off immediately using the patient magnet. Operating the device near gas fumes or vapors could cause them to catch fire. 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. Operation of machines, equipment, and vehicles. High amplitudes and wide pulse widths should only be programmed with due consideration of the warnings concerning charge densities. Proclaim XR SCS System Meaningful relief from chronic pain. Computed tomography (CT). Injury or damage can occur during diathermy treatment whether the neurostimulation system is turned on or off. In addition, a component must be implanted in its approved location as listed in the following table or the entire implanted system is considered MRUnsafe. (Bluetooth is a registered trademark of Bluetooth SIG, Inc.). Component manipulation by patient. The neurostimulation system is indicated for the following conditions: Bilateral stimulation of the subthalamic nucleus (STN) or the internal globus pallidus (GPi) as an adjunctive therapy to reduce some of the symptoms of advanced levodopa-responsive Parkinsons disease that are not adequately controlled by medications. If the patient requires a CT scan, all stimulation should be turned off before the procedure. If multiple leads are implanted, leads and extensions should be routed in close proximity. 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. 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. Always perform removal with the patient conscious and able to give feedback. For complete and comprehensive MRI support, parameters, and precautions for all Abbott neuromodulation systems, please see the product manual for each of our devices. Deep brain stimulation potentially has the following adverse effects: Possible surgical complications. If gas fumes or vapors catch fire, it could cause severe burns, injury, or death. Pressures below 30 m (100 ft.) of water (or above 4.0 ATA) could damage the neurostimulation system. Safety has not been established for radiofrequency (RF) or microwave ablation in patients who have an implanted neurostimulation system. Electrosurgery. Avoid excessive stimulation. 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. The following procedures are contraindicated for patients that have been implanted with this device: Diathermy therapy. 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. 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. 2013;16(5):471-482. Neurosurgery Pain Management Orthopaedic Surgery Scuba diving or hyperbaric chambers. 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. Exposure of the metal contacts, such as those on the connection end of a lead or extension, to body fluids or saline prior to connection can lead to corrosion. After defibrillation, confirm the neurostimulation system is still working. To find Shipping Material Packaging Waste information, select Healthcare Professionals. Diathermy therapy. 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. Patients should take reasonable care to avoid devices that generate strong EMI, which may cause the neurostimulation system to unintentionally turn on or off. For adverse effects observed in SCS clinical studies, refer to the clinical summaries manual for SCS systems. Electrosurgery. Bending the sheath. Patient's age, as very young or very old patients may have difficulty performing required monitoring of the device. Wireless use restrictions. Do not use the application if the operating system is compromised (that is, jailbroken). ** Before reinserting the sheath, verify there is no damage to the sheath. Physicians should also discuss any risks of MRI with patients. Poor surgical risks. Device modification. The use of ultrasonic scanning equipment may cause mechanical damage to an implanted neurostimulation system if used directly over the implanted system. Complete any electrosurgery before connecting the leads or extensions to the neurostimulator. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. Stimulation Modes. Care and handling of components. Return all explanted generators to Abbott Medical for safe disposal. 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. 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). Equipment is not serviceable by the customer. 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. Object Category Spinal Cord Stimulation Systems: St. Jude Medical. Use extreme care when using sharp instruments or electrosurgery devices around the lead to avoid damaging the lead. Patients should also avoid any activities that would be potentially unsafe if their symptoms were to return unexpectedly. NOTE: During intraoperative testing, Surgery mode must be turned off for the neurostimulation system to function correctly. Sheath insertion warning. Single-use, sterile device. Read this section to gather important prescription and safety information. Implanting physicians should be experienced in the diagnosis and treatment of chronic pain syndromes and have undergone surgical and device implantation training for dorsal root ganglion (DRG) neurostimulation systems. 74372 MAT-2215216 v3.0 | Item approved for U.S. use only. Lead handling. 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. Safety for use of external defibrillator discharges on a patient receiving neurostimulation has not been established. Therefore, the literature and clinical studies represent the safety and effectiveness of this neurostimulation system. All components listed must be implanted unless noted as "optional." Especially consider the following additional factors when selecting patients: Level of available support from a caregiver. Pregnancy and nursing. Stimulation effectiveness. radiofrequency identification (RFID) devices. Therefore, it is unlikely patients will need to adjust stimulation when changing positions or moving. 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. Store components and their packaging where they will not come in contact with liquids of any kind. If unpleasant sensations occur, turn off stimulation immediately. High-output ultrasonics and lithotripsy. Ensure the neurostimulator is off before initiating an electrocardiogram (ECG). Damage to the system may not be immediately detectable. This system is contraindicated for patients who are unable to operate the system or who have failed to receive effective pain relief during trial stimulation. Emergency procedures. Case damage. Patients should exercise reasonable caution when bathing. Do not handle the IPG if the case is pierced or ruptured because severe burns could result from exposure to battery chemicals. 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. Risk of depression, suicidal ideations, and suicide. Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards. Patients should cautiously approach such devices and should request help to bypass them. IPG disposal. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Surgical complications and adverse events may be more frequent and severe in patients with diabetes. Infections related to system implantation might require that the device be explanted. Excessive lead migration may require reoperation to replace the leads. Always remove the trial leads before implanting the implant leads to avoid the risk of infection that may cause death if the leads are not removed. Battery precaution. It is extremely important to select patients appropriately for neurostimulation. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia). If unpleasant sensations occur, the device should be turned off immediately. Overcommunicating with the IPG. Do not crush, puncture, or burn the generator because explosion or fire may result. Needle insertion. 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. Therapeutic radiation. Therapeutic radiation. Exit Surgery mode during intraoperative testing and after the procedure is completed. Infection. All components listed must be implanted unless noted as "optional."