While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. Diathermy is further prohibited because it may also damage the neurostimulation system components. All patients are advised to inform their healthcare professional that they should not be exposed to diathermy treatment. Patients should avoid activities that may put undue stress on the implanted components of the neurostimulation system. Confirm that the neurostimulation system is functioning correctly during the implant procedure and before closing the neurostimulator pocket. 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. 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. When using a contralateral approach, advance the needle slowly into the epidural space and take caution as it enters. 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. Maximize the distance between the implanted systems; Verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and. The BurstDR stimulation mode has not been evaluated for effectiveness in the diabetic peripheral neuropathy (DPN) population. The needle will be inserted at a steeper angle than in an antegrade approach and there is a greater chance of dural puncture that will lead to a cerebrospinal fluid leak. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for at least six weeks after implantation. The Prodigy MRI SCS System delivers effective pain relief through spinal cord stimulation (SCS) using Abbott's smallest implantable pulse generator (IPG). Abandoned leads and replacement leads. After defibrillation, confirm the neurostimulation system is still working. 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, which are implanted, electrically insulated wires that transmit electrical impulses to the target nerves Inserting the anchor. Surgical advice for removal. Clinician programmers, patient controllers, and chargers are not waterproof. Insertion of a sheath without the lead may result in dural puncture. 72184 MAT-2214513 v1.0 | Item approved for U.S. use only. Therefore, physicians should consider the following: Preoperatively, assess patients for the risks of depression and suicide. 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. Security, antitheft, and radiofrequency identification (RFID) devices. Placing the IPG deeper than 4 cm (1.57 in) can impede or prohibit IPG communications with the clinician programmer or patient controller. 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. Removing a kinked sheath. six to eight weeks after implantation of a neurostimulation system. Free from the hassles of recharging. Placing the IPG. The clinician programmer and patient controller contain a battery and other potentially hazardous materials. Patients who failed to receive effective pain relief during trial stimulation are contraindicated to process to the permanent implant procedure. The use of high-output devices, such as an electrohydraulic lithotriptor, may cause damage to the electronic circuitry of an implanted IPG. Failure to do so may result in difficulty delivering the lead. Damage to the system may not be immediately detectable. Patients should not dive below 30 m (100 ft) of water or enter hyperbaric chambers above 4.0 atmospheres absolute (ATA). Manipulation may cause device inversion, inhibiting the ability to use the magnet to start or stop stimulation. Wireless use restrictions. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. 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. Wireless use restrictions. 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. Use extreme care when removing the lead stylet, the delivery sheath, and the needle to ensure that the distal tip of the lead remains in the desired location. Return all explanted components to Abbott Medical for safe disposal. Output power below 80 W is recommended for all activations. External defibrillation can cause induced currents in the lead-extension portion of the neurostimulation system. Sheath insertion precaution. A physician can help determine if a patient is eligible to receive an MRI scan by following the requirements provided by Abbott Medical. 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. Safety Topic / Subject Spinal Cord Stimulation (SCS) Systems, Abbott and St. Jude Medical. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. Anchoring leads. 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. This damage could result in loss of therapy, requiring additional surgery for system implantation and replacement. This damage could result in loss of therapy, requiring additional surgery for system replacement. Patient training. Application modification. Preventing infection. 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. Excessive heat, excessive traction, excessive bending, excessive twisting, or the use of sharp instruments may damage and cause failure of the components. If the sheath needs to be retracted from the epidural space, verify that the steering wing is rotated away from the needle mark no more than 90 degrees. Changes secondary to neuropathic pain seen in CRPS I (RSD) may be present, but are not a diagnostic requirement for CRPS II (causalgia). Nerve damage may result from traumatic or surgical nerve injury. Spinal cord stimulation of the dorsal root ganglion for groin pain-a retrospective review. Place the neurostimulator in Surgery mode before using an electrosurgery device. 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. Providing strain relief. 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. Expected effect from cessation of therapy, should disease symptoms return unexpectedly. During the 2000s about a dozen companies sold and manufactured SCS systems worldwide, including the "big three" (Boston Scientific, Abbott/St. Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. 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. Patients should cautiously approach such devices and should request help to bypass them. Patients should cautiously approach such devices and should request help to bypass them. 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. Placement of lead connection in neck. Clinician training. If needed, return the equipment to Abbott Medical for service. The neurostimulation system may interfere with the normal operation of another active implanted device, such as a pacemaker, defibrillator, or another type of neurostimulator. The U.S. Food and Drug Administration (FDA) has approved Abbott 's request to expand the magnetic resonance imaging (MRI) compatibility with its Proclaim XR spinal cord stimulation system with . Sudden loss of stimulation may cause patients to fall or lose control of equipment or vehicles, injure others, or bring injury upon themselves. 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. Implantation of two systems. However, current data shows that most patients using BurstDR stimulation therapy do not experience paresthesia. Therapeutic radiation. Number of leads implanted. A physician should determine whether or not a patient may have an allergic reaction to these materials before the system is implanted. 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. Do not use surgical instruments to handle the lead. Advise patients to keep the patient controller away from children and pets in order to avoid potential damage or other hazards. For information that supports the clinical use of this neurostimulation system, refer to the clinical summaries manual for spinal cord stimulation (SCS) systems. maximize the distance between the implanted systems; Use in patients with diabetes. 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. Stimulation Modes. The severity of any surgical complication may be greater in patients with diabetes, particularly those with inadequate pre-operative glycemic control. Back pain. Implanted cardiac systems. Explosive and flammable gasses. 71409MAT-2116350 v4.0 | Item approved for U.S. use only. Neurostimulation should not be used for patients with comorbidities that could prevent successful implant or effective therapy. The safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established. Patients should be advised to keep their mobile phones and smart watches at least 15 cm (6 in.) Lead movement. 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. Removing components. Electrosurgery. Changes in blood glucose levels in response to any adverse effect Security, antitheft, and radiofrequency identification (RFID) devices. 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. Avoid excessive stimulation. 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. No use of any Abbott trademark, trade name, or trade dress in this site may be made without the prior written authorization of Abbott, except to identify the product or services of the company. Follow proper infection control procedures. Securing the lead with the lead stabilizer will mitigate this risk. Mobile phones. 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. External defibrillation can cause induced currents in the leadextension portion of the neurostimulation system. The Proclaim XR SCS system can provide relief to . In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. Physicians should use extreme care with lead implantation in patients with a heightened risk of intracranial hemorrhage. IPG placement. Use extreme care to not damage the lead with the sharp point of the tunneling tool. 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. Consumer goods and electronic devices. Neurostimulation should not be used on patients who are poor surgical risks or patients with multiple illnesses or active general infections. Stimulation at high outputs may cause unpleasant sensations or motor disturbances or may render the patient incapable of controlling the patient controller. Proclaim XR SCS System Meaningful relief from chronic pain. 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 radiation therapy is required, the area over the implanted generator should be shielded with lead. 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. Use extreme care when handling system components prior to implantation. If resistance is met while removing leads from the epidural space, do not use excessive force to extract. 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. Instruct patients to use their neurostimulation system only after an authorized clinician has programmed the generator and has trained the patient on how to safely control stimulation and to charge the system. If needed, return the equipment to Abbott Medical for service. Sources of therapeutic radiation include therapeutic X rays, cobalt machines, and linear accelerators. Therapeutic radiation. Complete any electrosurgery before connecting the leads or extensions to the neurostimulator. Do not use the application if the operating system is compromised (that is, jailbroken). between lead ends is recommended); Verify that the neurostimulation system is not interfering with the function of the implanted cardiac system; and. If the lead is unable to deploy out of the sheath, inject sterile water or saline slowly to release tissue that may have entered between the sheath and the lead. This neurostimulation system is similar in technology and intended use to the systems reported in the literature and clinical studies. In rare cases, this can create a medical emergency. Advise patients who experience these types of stimulation changes to turn down the amplitude or turn off the IPG before making extreme posture changes or abrupt movements such as stretching, lifting their arms over their heads, or exercising. 737202011056 v5.0 | Item approved for U.S. use only.