The safety of discharge of an external defibrillator on patients with implanted neurostimulation systems has not been established. Do not perform an MRI scan on patients who have any portion of their implanted system exposed due to skin erosion. Diathermy . The MRI scan may cause heating of the system, which could result in serious patient injury. Please read the Legal Notice for further details. See Important Considerations for an MRI Scan. If your device is not MRI compatible, MRIs can cause serious injury. Once in place, they emit a low-voltage electrical … However, some patients may experience a decrease or increase in the perceived level of 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. Safety Info ID# Safety Topic / Subject Article Text 356: Neurostimulation System: Senza Spinal Cord Stimulation System, Nevro Corporation: Neurostimulation System: Senza Spinal Cord Stimulation System Nevro Corporation. Explant any previously abandoned pain leads or extensions that may be in the patient (ie, leads or extensions, or portions of, that are not connected to a neurostimulator). Spinal cord stimulation is a compelling treatment alternative for patients with chronic pain who have failed conservative treatment approaches. Component disposal. To minimize or prevent the implanted cardiac system from sensing the output of the neurostimulation system, (1) maximize the distance between the implanted systems; (2) verify that the neurostimulation system is not interfering with the functions of the implanted cardiac system; and (3) avoid programming either device in a unipolar mode (using the device’s can as an anode) or using neurostimulation system settings that interfere with the function of the implantable cardiac system. … Advise patients to use caution when undergoing any procedure that could include radiofrequency (RF) or microwave ablation, defibrillation, or cardioversion. MRI-Compatible Spinal Cord Stimulator Device and Related Changes in Patient Safety and Imaging Artifacts Jose De Andres, MD, PhD, FIPP, EDRA, Jose De Andres, MD, PhD, FIPP, EDRA Search for other works by this author on: Oxford Academic. For more information about MRI safety and your Abbott neurostimulator, and instructions on how to put your device in MRI mode: Interested in learning more about neurostimulation for your chronic pain? Using surgical instruments. Stimwave is a neuromodulation company cleared by the FDA for our revolutionary, micro-invasive, battery-free device to reduce chronic pain by pinpointing stimulation directly to the affected spinal cord or peripheral nerves with a multi-electrode, programmable device which enables ongoing MRI scans. You should not be exposed to Magnetic Resonance Imaging (MRI). In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. All Rights Reserved. pertains to shielded MRI systems with static magnetic fields of 1.5 Tesla or less (maximum spatial gradient In the clinical experience with this device, patients have experienced few effects when moving from lying down to sitting up. Handle the device with care. The Medtronic SCS SureScan MRI System includes a family of neurostimulators, Vectris percutaneous and surgical paddle leads. Spinal cord stimulators may set off metal detectors (such as in airports). Follow proper infection control procedures. should not prescribe MRI for patients undergoing trial stimulation or who have any neurostimulation system components that are not fully implanted. The purpose of this investigation was to evaluate MRI safety issues (magnetic field interactions, MRI-related heating, functional disturbances, and artifacts) for a new wirelessly powered lead with receiver used for SCS. Safety Info ID# Safety Topic / Subject Article Text 255: Bone Fusion (Spinal) Stimulator: The implantable bone fusion or spinal fusion stimulator is designed for use as an adjunct therapy to a spinal fusion procedure. Move through the device quickly. Patients should be instructed to avoid bending, twisting, stretching, and lifting objects over 2 kg (5 lb) for at least six weeks after implantation. Lead handling. Here you will find important information about ImageReady MRI technology, supported devices and conditions for use. While interference with mobile phones is not anticipated, technology continues to change and interaction between a neurostimulation system and a mobile phone is possible. 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. ... Specify™ SureScan MRI surgical leads; Injex™ anchors (for use with percutaneous leads only) ... Safety, and Warnings. Electrocautery is generally not recommended in these patients but sometimes used despite known risks. Fully charge your patient controller before your procedure. Bending the sheath. The safety of performing magnetic resonance imaging (MRI) in patients with spinal cord stimulation (SCS) systems needs to be documented. The control temperature rises at the same locations, without the stimulator, were less than 0.5 degree C. This study shows that spinal fusion stimulator heating is within the Food and Drug Administration safety guideline of 2 degrees C. However, if a lead wire is broken, it is unsafe during MRI scans. For more information about whether or not it is safe to receive an MRI with your device, please refer to the product manual. NOTE: Enter the patient’s weight into the MR system console to ensure that the whole body averaged specific absorption rate (SAR) is estimated correctly. So long as your spinal cord stimulator is powered off, X-rays and CT scans are generally safe. The following steps must be performed prior to an MRI on a patient with an implanted Freedom Stimulator: Non-clinical testing has demonstrated the Freedom-8A SCS Stimulator Receiver is MR Conditional. Safety and effectiveness of neurostimulation for use during pregnancy and nursing have not been established. IPG disposal. OBJECTIVE. This information is located on your Abbott Patient ID card and on the Patient Eligibility Form for MRI Scans. 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. System testing. The clinician programmer and patient controller are sensitive electronic devices that can be damaged by rough handling, such as dropping them on the ground. Spinal cord stimulation and peripheral nerve field stimulation are considered generally safe, with the potential risks mainly related to the surgical procedures required for a trial period or long-term therapy. PRODIGY MRI™ SCS IMPLANTED PULSE GENERATOR. Medical imaging techniques such as MRI scans are often used by doctors when checking for certain health conditions. The purpose of this investigation was to evaluate MRI … Exposure to this diagnostic technology may result in tissue damage, dislodgement of your Stimulator or leads, heating of the Stimulator, severe damage to the Stimulator electronics and/or increased voltage through the leads or Stimulator which can cause an uncomfortable or “jolting” sensation. Fear of litigation can also confound choice of … Too much pressure on the stylet could damage the lead, resulting in intermittent or loss of stimulation. 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. MATERIALS AND METHODS. Carefully inspect the lead (in the sterile field) for damage after removing it from the sterile package. 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. Magnetic resonance imaging (MRI) is considered safe under strict labeling conditions. Case damage. Your pain specialist may also provide you with a. Stabilizing the lead during insertion. Poor surgical risks. Component Model/Catalog Number MR Conditionally Safe Implant Location Stimulator 3 x 8 2408 Buttocks, abdomen, or flank Stimulator 2 x 12 2412 Buttocks, abdomen, or flank 8 - Electrode Lead 1 mm or 4 mm spacings in 45, 60 or 75 cm lengths 1081 … No, MRIs are not always safe for those with spinal cord stimulation devices. Advise patients to contact their physician if they are concerned about their mobile phone interacting with their neurostimulation system. 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. MRI is an imaging modality frequently ordered for patients with neuromodulation systems implanted for spinal cord stimulation. Abbott neurostimulators are designed so you can have an MRI of either your whole body or just your head and extremities, but there are several precautions you should take any time a doctor prescribes an MRI scan.