and any use of such marks by Nevro Corp. The Senza®, Senza II™and Senza Omnia™neuromodulation systems, whenIntroduction. ContraindicationsA comprehensive, authoritative textbook on MRI health & safety concerns with contributions from more than fifty internationally respected experts in the field. . A patient with Stryker Detachable Coils can be safely scanned immediately after placement of the coils, under the following conditions: Static magnetic field of 1. Company/Org Logo: About Company: Headquartered in Redwood City, California, Nevro is a global medical device company focused on providing innovative products that improve the quality of life of patients suffering from debilitating chronic pain. Nevro Senza Spinal Cord Stimulator ‐ MRI available Mon‐Fri, 8am‐5pm; Univ Hospital Only. 1800 Bridge Parkway Redwood City, CA 94065 USA 1. . On the back of the commercialization of Senza in the European Union and Australia, achieved over the past 5 years, Nevro reported revenues of $9. 5T and 3T imaging. Nevro Senza Spinal Cord Stimulator ‐ MRI available Mon‐Fri, 8am‐5pm; Univ Hospital Only. Class action. Risks Associated with MRI with Senza System . o. the risk of severe injury or death. The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. HFX iQ is a smart pain management system that uses the largest clinical SCS dataset to recommend the starting program most likely to provide pain relief 1 and adjusts therapy based on each patient's responses to maintain optimized relief. Table of Contents INTRODUCTION. Applicant’s Name and Address: Nevro Corp. V. The Senza®, Senza II™and Senza Omnia™neuromodulation systems, when Expanding Patient Access to Nevro's HF10 Therapy through Broader Imaging Compatibility REDWOOD CITY, California , Nov. Furthermore, it is not intended to increase or maximize reimbursement by any payer. Data on file. You control the implanted device with the same Remote Control. (NYSE: NVRO), a medical device company that has developed and commercialized an innovative, evidence-based neuromodulation platform for the treatment of chronic pain, today announced that it has received CE Mark for. Nevro has developed and commercialized the Senza spinal cord stimulation (SCS) system, an evidence-based, non-pharmacologic neuromodulation platform for the treatment of chronic pain. . Senza Summary of Safety and Effectiveness Data (SSED). More . Nevro has developed and commercialized the Senza spinal cord stimulation (SCS) system, an evidence-based, non-pharmacologic neuromodulation platform for the treatment of chronic pain. S. This includes pain associated with failed back surgery syndrome, intractable low back pain, and leg pain. The Redwood City, Calif. S. Webinar Learn About Nevro HFX + Hear From a Nevro HFX Patient YouTube Implantierbarer Neurostimulator Senza® Nevro Corp. Now Available, FDA-Approved, Artificial Intelligence-based HFX iQ™. This afternoon. *HFX is a comprehensive solution that includes a Senza spinal cord stimulation system and support services for the treatment of chronic pain. Nevro HFX. The potential risks of performing MRI on patients with an implanted Senza system include: - Device movement - Excessive heating of or around the implanted device components - Tissue damage - Damage to the device - Uncomfortable sensation - Image artifact . Keith Grossman Chairman, Chief Executive Officer and President *Senza HFX iQ™ uses a fixed set of instructions to provide optimized treatment recommendations that utilizeYes, with HFX you can safely have a full-body MRI scan. 12-Month durability and crossover results published in Diabetes Care. de modèle : LEAD2008-xxB), des ancrages d'électrode (n. Die Bluetooth®-Wortmarke und -Logos sind eingetragene Marken von Bluetooth SIG, Inc. The cost for a spinal cord stimulator is much like any medical procedure or surgery, costs vary from person to person. Indications for Use: The Senza®, Senza II™ and Senza Omnia™ neuromodulation systems are used as aids in the management of chronic intractable pain of the trunk and/or limbs. Bring your patient ID card and Remote Control to the MRI appointment. 1800 Bridge Parkway Redwood City, CA 94065 U. 04 Feb, 2015, 04:01 ET. Bench top tests have shown that. Our SCS systems are now approved to deliver 2. the nature of the event but was unsuccessful. Conclusion. Nevro has developed and commercialized the Senza. 0 T MRI (30 of 30 found with both technologies), and clinical diagnoses were the same for 1. TM. Pediatric Use – The safety and effectiveness of spinal cord stimulation has not been established for pediatric use. (NYSE: NVRO), a global medical device company that is providing innovative evidence-based solutions for the treatment of chronic pain, today announced that full-body magnetic resonance imaging (MRI) conditional labeling is now. Also, please discuss. DRAFT 16. NEVRO CORP. . It is implanted under the skin and has an inbuilt battery. Scanning under diffe rent conditions may result in severe injury,Increase Patient Freedom. 251. The Senza neuromodulation system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain, and leg pain. The system is capable of delivering HF10® therapy, a therapy that does not produce tingling sensations called paresthesia. SENZA®, SENZA II® and SENZA Omnia™ will 11096 Rev M 2 . . Nevro® ®hereby declares that the Senza HFX iQTM System and Senza® HFXTM Trial System is in compliance with the essential requirements and other relevant provisions of the Radio Equipment Directive (2014/53/EU) and U. If you don’t have your patient ID card, please call your HFX Care Team for assistance. 2007;188(5):1388–94. In the future, you may need magnetic resonance imaging (MRI) to diagnose an illness. Quick, outpatient & minimally invasive. All was well until a week ago when I started to experience pain at the battery implant site. Noter que les éléments MR Conditional du système Senza . IMPORTANT: Do not change or modify any component of the Senza ® TMHFX iQ. Nevro's comprehensive HFX™ spinal cord stimulation (SCS) platform includes a Senza SCS system and support services for the treatment of chronic pain of the trunk and limb and painful diabetic. So,. Tel: +1. Paresthesia-Free with HF10®1,2 With HF10® programs (stimulation at 10,000 Hz),. 000 Hz und eine Kombination aus diesen abzudecken. Every person is unique and your. *Within conditional parameters. This includes one-sided or two-sided pain associated with failed back surgery syndrome, intractable low back pain, and leg pain. The company also offers a newer system called Senza II, which delivers the same HF10 therapy. User Manual 11405 RevX Jason Smith Users Manual 01 Nevro Corporation PR1D3000 Patient Remote XKYPR1D3000 pr1d3000 PATIENT MANUAL Senza BLUETOOTH Trial System Effective May 2020 10000890 Rev 02 All questions or concerns about Nevro Corp. Nevro aims to develop and publish rigorous evidence to support critical decisions made by physicians, regulators and payors. 12. MRI Safety (Neurovascular Use) Non-clinical testing and analysis have demonstrated that when used in the neurovasculture, Stryker Detachable Coils are MR Conditional. Guidelines. You will first go through a trial phase where you and your doctor evaluate the therapy to see if its right for you. The Senza System has a very similar safety profile to other SCS devices that have been available for many years. 650. In Commercial Distribution. User manual instruction guide for Implantable Spinal Cord Stimulator IPG2000 Nevro Corporation. (NYSE: NVRO), a medical device company that is providing innovative evidence-based solutions for the treatment of chronic pain, today announced that it has received approval from the United States Food and Drug Administration (FDA) for its Senza spinal cord stimulation (SCS). HFX spinal cord stimulation is approved for full-body MRI scans*, CT scans, and ultrasounds, allowing you to receive the care you need . AccessGUDID - Nevro (00813426020510)- Senza II. The primary endpoint of the study is a composite endpoint that includes the difference in proportion of treatment responders without. System and Senza ® HFX. de modèle : NIPG1000 ou NIPG1500). The evolution of neuromodulation devices in order to enter magnetic resonance imaging (MRI) scanners has been one of understanding limitations, engineering modifications, and the development of a consensus within the community in which the FDA could safely administer labeling for the devices. 650. 12. Andere Marken und Handelsnamen sind Now Available, FDA-Approved, Artificial Intelligence-based HFX iQ™. Bühne frei für Senza. Safety Topic / Subject Neurostimulation System: Senza Spinal Cord Stimulation System, Nevro Corporation. You can We would like to show you a description here but the site won’t allow us. Nevro Corp. A. 251. * If you need more information about compatibility with MRI and CT scans, please contact your Nevro HFX Care Team at 1-888-895-8105. Brand Name: Senza® . Neurostimulation System: Senza Spinal Cord Stimulation System Nevro Corporation. Please reference the “Impedance Check Instructions” section in this booklet. The Senza®, Senza II™ and Senza Omnia™Senza is the First Implantable Spinal Cord Stimulator System that is 3 Tesla MRI Compatible Nevro Corp. 7. 7: Sep 13, 2022: Treatment of Congestive Heart Failure With Electrical Stimulation, and Associated Systems and MethodsSafety Topic/Article: The implanted Senza Spinal Cord Stimulation (SCS) System (Nevro Corporation) is MR Conditional and has been demonstrated to present no known hazards in a specified MRI environment when following specific guidelines as described in the 1. Willard Daniel 08 Jul 2023. All questions or concerns about Nevro Corp. Product Name: Senza Spinal Cord Stimulation (SCS) System PMA Applicant: Nevro Corporation Address: 1800 Bridge Parkway Redwood City, CA 94065 Approval Date: January 18, 2022 Approval Letter. Allows for the delivery of 2-1200 Hz & 10,000 Hz frequencies in SCS, with the ability to easily pair the widest array of waveforms; Omnia Patient Accessories. 1. Minimal restrictions and reversible. Tyto pokyny naleznete také na webu společnosti Nevro (. Nevro SENZA®, SENZA II® and SENZA Omnia™ Spinal Cord Stimulation (SCS) implantable pulse generators (IPG) are MR Conditional devices that have been demonstrated to present no known hazards in a specified MR environment when following specific guidelines as described in this document. . Nevro® SENZA®, SENZA II® and SENZA Omnia™ Spinal Cord Stimulation (SCS) implantable pulse generators (IPG) are MR Conditional devices that have been. . Two crossed lines that form an 'X'. (MRI) - The Senza system is MR Conditional which . Nevro Corp. I understand these communications may include advertisements for goods and I can unsubscribe at any time. The Senza Omnia is the first and only SCS. 5. q4cdn. Comparison of 10-kHz High-Frequency and Traditional Low-Frequency Spinal Cord Stimulation for the Treatment of Chronic Back. You will first use the Trial Stimulator and Remote Control. 0 T MRI, as both were used to identify nine tumours, metastatic infiltration in 16 patients, and fibre thickening in two patients (nerve tumours and brachial. I am riding my bike, tending my garden, pursuing my passion for crafts and traveling, and I no longer take any pain meds. products should be forwarded to: Nevro Corp. You will first go through a trial phase where you and your doctor evaluate the therapy to see if its right for you. My pain management doctor has recommended it to me for. All questions or concerns about Nevro products should be forwarded to: Nevro Corp. Senza, HF10, Nevro and the Nevro logo are. (NYSE: BSX) announced today that they have reached a settlement in their ongoing intellectual property litigations that gives Boston Scientific the freedom to operate using the features and capabilities embodied in its current line of products for frequencies below 1,500 Hz, and. . 0 months post implant (min=0. An electrically-powered, implantable component of a spinal cord/peripheral nerve implantable analgesic electrical stimulation. . . 9415 [email protected] Senza Spinal Cord Stimulation System Nevro Corporation, Strength 1. comNevro, a firm based in Silicon Valley, won FDA approval for its Senza Omnia spinal cord neurostimulation system for chronic pain management. Device Procode: LGW . Contraindications Senza is the First Implantable Spinal Cord Stimulator System that is 3 Tesla MRI Compatible Nevro Corp. Conflict of Interest: Dawood Sayed serves as a consultant to Abbott, Boston Scientific, Flowonix, Medtronic, Nevro, PainTEQ, SPR Therapeutics, Vertos, and Vertiflex. NSRBP RCT. Please be aware that the website you have requested is intended for the residents of a particular country or region, as noted on that site. MRI . g. to limit activities that are more likely to cause the leads to move. This document is a supplement to the Senza system Physician Implant and Patient Manuals and is related only to the use of a transmit/receive radio frequency (RF) head or local coils of a 1. This includes one-sided or two-sided pain associated with failed back surgery syndrome, intractable low back pain, and leg pain. Version (Model) Number: NIPG1500. 5, 3:Nevro today announced it has received approval from the US Food and Drug Administration (FDA) for the Senza Omnia spinal cord stimulation (SCS) system. p: +1-650-251-0005 Australian Contact Number: 02 8091 2878Side effects or risks involved with the Senza System: Important Safety Information 10 kHz Therapy and other available SCS frequencies and waveforms are delivered by Senza Spinal Cord Stimulation (SCS) systems. **MRI data accurate as of 2021. . The implanted Senza Spinal Cord Stimulation (SCS) System (Nevro Corporation) is MR Conditional and has been demonstrated to present no known hazards in a specified MRI environment when following specific guidelines as described in the 1. 251. Despite technical challenges, MRI is feasible, safe and diagnostically useful in HF-SCS-implanted patients. - Patient consented and consent form to be signed by EP. Appendix: SENZA System MRI Scan Checklist This checklist is provided as an optional resource to support MR centers in conducting and MRI of a patient implanted with the Nevro SENZA system. FCC CFR 47 Part 15. SENZA NEVRO SENZA: Back to Search Results: Model Number LEAD1058-70B: Device Problem Adverse Event Without Identified Device or Use Problem (2993) Patient Problems Wound Dehiscence (1154); Unspecified Infection (1930) Event Date 11/04/2019: Event Type Injury Manufacturer Narrative. . NEVRO CORP. 251. (NYSE: NVRO), a global medical device companyRisks Associated with MRI with Senza System. Refer to Senza MRI Guidelines for detailed information on MRI safety and conditions. ‐ 1. 1800 Bridge Parkway Redwood City, CA 94065, USA Tel: +1. Please see the Patient Manual for important safety information and detailed MRI information. , March 22, 2018 /PRNewswire/ -- Nevro Corp. . In the US, our SCS systems are now approved to deliver all available SCS frequencies and the most waveform types in a single product, helping people living with chronic pain. FOLLOW THE INSTRUCTIONS FOR USE IF SYMPTOMS PERSIST SEE YOUR DOCTOR/HEALTHCARE PROFESSIONAL. Risks Associated with MRI with Senza System. Objectives. For commercial claims, please confirm device coding with payer prior to billing (see tables on pages six and seven). Talk to your doctor about complications related to the procedure and/or device, which include infection, swelling, bruising, undesirable changes in stimulation and loss of strength or use in an affected limb or muscle group (e. The Senza System has a very similar safety profile to other SCS devices that have been available for many years. Full Body MRI7 All Nevro systems are conditionally approved for full body MRI scans. All questions or concerns about Nevro Corp. Quick, outpatient & minimally invasive. All questions or concerns about Nevro products should be forwarded to: Nevro Corp. Overview. Commercial Distribution Status. M8 and S8 Adaptors . Important safety, side effects, and risks information. Stellen Sie folgende Punkte sicher, falls ein Arzt eine MRT-Untersuchung bei Ihnen anordnet: 1. Also, please discuss. 11, 2022 /PRNewswire/ -- Nevro Corp. . The Senza System has a very similar safety profile to other SCS devices that have been available for many years. The Senza System has a very similar safety profile to other SCS devices that have been available for many years. It is also capable of providing stimulation that producesMedical device company Nevro has launched Senza Omnia Spinal Cord Stimulation (SCS) System to treat chronic pain in the US, following the US Food and Drug Administration (FDA) approval. . All questions or concerns about Nevro Corp. We’re here to help you. Nevro Corporation, Risks Associated with MRI with Senza System . Click to view and download the complete guide now!. 5-T and 3-T Magnetic Resonance Imaging (MRI) Guidelines for the Senza system. (NYSE: NVRO), a global medical device company that is delivering comprehensive, life-changing solutions for the treatment of chronic pain, today announced that on October 1, 2022, UnitedHealthcare ("United") released an update to its medical coverage policy ( number 2022T0567V ) and added language to indicate spinal. Risks Associated with MRI with Senza System . Device Name: Senza® IPG Kit. A. Eseguire un esame MRIVectris™ SureScan® MRI 1x8 Subcompact Model 977A160, 977A175, 977A190;. Some key features include: turn stim on/off, check battery, turn on MRI mode. and our belief that the safety and efficacy data from the SENZA-NSRBP RCT will be used to support increased patient access and. Safety Topic / Subject. • The Senza system was the subject of the SENZA-RCT pivotal study, a ground-breaking study that was the first to. 15, 2017 /PRNewswire/ -. 5T and 3T MRI Guidelines Rev C Page 5 Introduction Nevro’s Senza Spinal Cord Stimulation (SCS) system is an MR Conditional device that has been demonstrated to present negligible hazards in a specified MR environment when following specificImportant safety, side effects, and risks information. AI Usage . Spinal Cord Stimulation System. Nevro patient satisfaction. Surpass surgical leads are MR conditional and therefore have demonstrated safety in the MR environment within defined conditions. Refer to Nevro HFX MRI Guidelines for detailed information on MRI safety and conditions. Bench top tests have shown that patients implanted with Senza system can be safely exposed to MR environments specified in this guideline. Farrukh Ansari. Tel: +1. S. Spectra WaveWriter™ SCS System. 00813426020602. 0 T MRI aims to provide health care. . MRI uses a powerful static magnetic field, gradient magnetic fields, and RF energy to construct an image of a section of the body. Head Only MRI Systems. and is capable of stimulating the spinal cord nerv es when used with one or more leads. It is is the first. Learn more about HFX iQ. Contraindications Please note that product literature varies by geography. The Senza neuromodulation system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs, including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back pain, and leg pain. com MDSS GMBH Schiffgraben 41 D-30175 Hannover, Germany Australian. Nevro Corp. Safety Topic / Subject. HF10 therapy has demonstrated the ability to reduce or eliminate opioids in ≥65% of patients across six peer-reviewed clinical studies. Nevro's battery is designed to last 10+ years at all common programming settings. . Indicates the MRI Safety Information, if. Also, please discuss the. MRI COMPATIBILITY. Patient Manuals and MRI Guidelines. 5T and 3T MRI Guidelines Rev C Page 5 Introduction Nevro’s Senza Spinal Cord Stimulation (SCS) system is an MR Conditional device that has been demonstrated to present negligible hazards in a specified MR environment when following specificRisks Associated with MRI with Senza System . g. , lumbar, truncal, in a limb) via. Patient position. With Nevro and leads and electrodes up the spine (as opposed to paddle leads, not sure about them) I could get an MRI of my hip. However, MRI safety recommendations continue to vary significantly between SCS models and companies (12-16). Pediatric Use - The safety and effectiveness of spinal cord stimulation has not been established for use in children. Nevro Corp. 2. If you do not follow these warnings, it is possible that you could be hurt and/or the device could be damaged. Find a Doctor. It is based on common questions that patients have about their condition, this particular treatment option, and the Senza system. The Senza, Senza II, Senza Omnia, and HFX iQ neuromodulation systems, when programmed to include a frequency of 10 kHz, are indicated as aids in the management of non-surgical refractory back pain (intractable back pain without prior surgery and not a candidate for back surgery). All questions or concerns about Nevro Corp. The safety of HFX has been thoroughly studied and proven. Nevro, SENZA, SENZA II, Omnia, SENZA Omnia, Senza Bluetooth®, Surpass, Surpass-C, HF10 und das Nevro-Logo. , lumbar, truncal, in a limb). In the back of the booklet, we have added some information in the appendices. Food and Drug Administration in 1984. UW Health Radiology Guidelines for MRI in Patients with Common Complex Devices:. They should only be exposed to MRI under conditions outlined in the instructions for use and the full-body MRI conditional label issued in November 2017. • Passing Elevator Accessory Tool: The Passing Elevator Accessory Tool is an optional surgical accessory tool, intended to assist implanting physicians in assessing and verifying that the epidural space is appropriately sized for. Magnetic Resonance Imaging (MRI) - The Senza system is MR. . At the time of your procedure, your doctor will provide your specific recovery instructions and it’s important to follow them closely. Other Active Implanted Devices – The Senza, Senza II, and Senza Omnia Systems may interfere with otherSenza® HFX iQ™ IPG Nevro Corp. SENZA; NEVRO SENZA: Back to Search Results: Model Number NIPG2000: Device Problem Adverse Event Without Identified Device or Use Problem (2993). Company Name: Nevro, Inc. Contraindications An assembly of devices that applies an electrical stimulus to all or part of the spinal cord to relieve pain (analgesia). 5 Tesla and 3 Tesla Magnetic Resonance Imaging (MRI) Guidelines for the SENZA®, SENZA II® & SENZA Omnia™ Systems. HFX permits full body MRI scanning under certain conditions. Company Name: NEVRO CORP. . If you don’t have your patient ID card, please call your HFX Care Team for assistance. Email: info@nevro. Magnetic Resonance Imaging Safety Status: MR CONDITIONAL: Indicates the MRI Safety Information, if any,. Estas instruções só se aplicam ao sistema Senza e não a outros produtos. Article Text. You will first go through a trial phase where you and your doctor evaluate the therapy to see if its right for you. . S. The Senza System has a very similar safety profile to other SCS devices that have been available for many years. The safety of HFX has been thoroughly studied and proven. Coding – Organized lists of CPT, ICD-10-CM, and relevant HCPCS codes. The potential risks of performing MRI on patients with an implanted Senza system include: - Device movement - Excessive heating of or around the implanted device components - Tissue damage - Damage to the device - Uncomfortable sensation - Image artifact . Published May 8 2015. A non-bioabsorbable device designed to be implanted into ligaments or other soft tissues to serve as a site of attachment for surgical binding materials/implants (e. The Senza SCS System is shown in Figure 1 below:AccessGUDID - Senza® (00813426020121)- Senza® Charger Kit . 187. 1 ASTM F2503-20, „Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment“ (Standardpraxis zur Kennzeichnung von Medizinprodukten und sonstigen Gegenständen. Global Unique Device ID: 00813426020510. 15 Tesla and 3 Tesla Magnetic Resonance Imaging MRI Guidelines for the SENZA® SENZA II® SENZA Omnia™ Systems IPG1000 IPG1500 IPG2000 and IPG2500 ONLY 11096 Rev F 2 NEVRO…The Nevro ® Senza ® SCS System for 10 kHz Therapy received CE mark in 2010, FDA approval in 2015, and is commercially available in Europe, Australia, and the United States. MRI system type. Easily pair the widest array of waveform types, including paresthesia-based. - Many. . Safety Topic / Subject Neurostimulation System: Senza Spinal Cord Stimulation System, Nevro Corporation. 251. The Redwood City, Calif. . 650. AccessGUDID - Nevro (00813426020510)- Senza II. For thiswe thank you for your continued support of Nevro. . The Omnia system is. . 5. 251. Every person is unique and your medical needs differ from those of others, even people with the same. Food and Drug Administration (FDA) for the Senza HFX iQ spinal cord stimulation (SCS) system. Event. , lumbar, truncal, in a limb) via percutaneously implanted electrodes (not included) to relieve. Safety Important Safety Information 10 kHz Therapy and other available SCS frequencies and waveforms are delivered by Senza Spinal Cord Stimulation (SCS) systems. 5T cylindrical-bore magnet, horizontal field orientation MRI systems. Vagus Nerve Stimulation, Vagal Nerve Stimulator, VNS Therapy, NeuroCybernetic Prosthesis (NCP) System (LivaNova and Cyberonics, Inc. [email protected] INSTRUCTIONS FOR USE AT ALL TIMES. comREDWOOD CITY, Calif. Specific information about your Nevro spinal cord stimulator can be found in the patient manuals. Nevro. Includes an optional custom latex-free adhesive pouch. **Battery data accurate as of 2021. (NYSE: NVRO), a global medical device company that is providing innovative evidence-based solutions for the treatment of chronic pain, today announced that full-body magnetic resonance imaging (MRI) conditional labeling is now available in the United States for. Kapural L, et al. Omnia. ). 7 million in Q1 2015, up 70% at constant currencies. Nevro recommends reviewing commercial contracts and medical policies to determine if it is appropriate to bill certain HCPCS codes described herein. The warnings and precautions can be found in the Senza SCS System labeling. 650. Programmers will display one of the icons below to indicate MRI eligibility based on the patient’s SCS system. All questions or concerns about Nevro products should be forwarded to: Nevro Corp. All questions or concerns about Nevro products should be forwarded to: Nevro Corp. products should be forwarded to: Nevro Corp. 251. AccessGUDID - Senza (00813426020770)- Trial Stimulator 3500 Kit. The Senza syste m components will include: Implantable pulse generator (IPG) is a small, battery-powered electronic device that is implanted. Appendix: SENZA System MRI Scan Checklist This checklist is provided as an optional resource to support MR centers in conducting and MRI of a patient implanted with the Nevro SENZA system.