2M XF"EEN"cL D3 0000025277 00000 n Your use of the other site is subject to the terms of use and privacy statement on that site. A patient implanted with the Axonics SNM Systems can undergo MRI examinations safely under the conditions . 0000006184 00000 n Impact of overactive bladder on women in the United States: results of anational survey. For applicable products, consult instructions for use onwww.medtronic.com/manuals. Connects directly to the lead, eliminating need for an extension Accommodates three lead sizes: 28 cm, 33 cm, and 41 cm Compatible with a lead insertion indicator in the lead Home 2013;100:959968. startxref The new guidelines add to Medtronics existing MRI label, which includes a comprehensive MRI Safety Guidance. 4.2. 0000000016 00000 n "Countless people suffer from symptoms of bladder and bowel control conditions and thanks to significant recent technology advancements, SNM therapy is becoming a more popular option for patients," said Jannah H. Thompson, M.D., FPMRS, president of the Society of Women in Urology, and urologist at Urologic Consultants in Grand Rapids, Michigan. If this patient is implanted with an InterStim II Model 3058 Neurostimulator or an eligible serial number of an InterStim Model 3023 Neurostimulator (when implanted as a system including a neurostimulator, lead, and, extension as applicable), MRI examinations of the head only may be safely performed, - Maximum spatial gradient of 19 T/m (1900 gauss/cm), - RF transmit/receive head coil only (no RF transmit body coil), - Gradient slew rate limited to 200 T/m/s, - Normal operating mode (Scanning frequency of approximately 64 MHz only), - Model 3058 and eligible Model 3023 Neurostimulators: Turn the neurostimulator, - Eligible Model 3023 Neurostimulators only: Disable the magnet switch, Scanning under different conditions may result in severe patient injury or device. b Power-on-reset (POR) turns OFF stimulation by resetting the amplitude to 0.0 V and all electrodes to OFF. Implanted pulse generators were examined before and after MRI procedures. However, if the conditions for safe MRI are MRI safety guidelines from Medtronic have expanded the range of scan parameters that clinicians can use to provide patients with a comprehensive, reliable, and safe MRI experience. The content of this website is exclusively reserved for Healthcare Professionals in countries with applicable health authority product registrations, except those practicing in France as some of the content is not in compliance with the French Advertising law N2011-2012 dated 29th December 2011, article 34. The Interstim II device can be safely scanned at 1.5 T. Bladder Control Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification. 2005;32:1118. Under certain conditions. Less information (see less). 0000010169 00000 n 0000017570 00000 n 0000009993 00000 n The InterStim II system is the only recharge-free, long-termSNM system that lets you get full-body* MRI scans. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. You may choose to re-enter your serial number, or contact Medtronic at one of the numbers below: Information for Healthcare Providers US Technical Services Department. Search by model name, product name, or device type. 756 0 obj For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronics website at www.medtronic.com. This therapy isappropriatefor bladder control patients who: This therapy isnot appropriatefor bladder control patients who: Many patients with chronic FI have poor or reduced quality of life because of their symptoms. 0000017228 00000 n 0000017893 00000 n Br J Surg. 0000006501 00000 n 0000008051 00000 n Tell the physician who prescribed your MRI scan that you have an implanted neurostimulation system. 0000024733 00000 n MRI mode is easy for patients to independently activate or deactivate on the smart programmer. If using an MRI SureScan device, see the MRI SureScan technical manual before performing an MRI. 0000011240 00000 n Between NBV133037H and NBV133063H ? For more information on Medtronic (NYSE:MDT), visit www.Medtronic.comand follow @Medtronic on Twitter and LinkedIn. This is important, as there are some very serious consequences if you are not aware of the right procedures to follow. This unintended stimulation may be uncomfortable (e.g., tingling, shocking, or jolting). These therapies are not for everyone. Not for human use in the US. Home 0000018863 00000 n 0000018547 00000 n p;X``pe`.)N]KA@!0834X@wP t(p 4qgp)h` j{ More information (see more) Contact your pain specialist to: See if you can safely undergo the type of MRI scan prescribed. 0000006985 00000 n J Manag Care Pharm. 0000005535 00000 n 0000023719 00000 n If this patient is implanted with an InterStim II Model 3058 Neurostimulator or an eligible serial number of an InterStim Model 3023 Neurostimulator (when implanted as a system including a neurostimulator, lead, and extension as applicable), MRI examinations of the head only may be safely performed under the following conditions: However, the safety of MRI of other body regions in InterStim II patients remains uncertain. United States Census Bureau Web site. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. "This is not your grandmother's therapy. This therapy is not intended for patients with pacemakers or implantable defibrillators, patients prone to excessive bleeding, patients with nerve damage that could impact either percutaneous tibial nerve or pelvic floor function, or on patients who are pregnant or planning pregnancy. MRI of the hand can be safely carried out with the Medtronic Interstim II device. Those lucky few will benefit from this devices latest enhancements. Medtronic Manuals: Region Manual Library Instructions for use and product manuals for healthcare professionals Please select your region. These patients are considered suitable for the InterStim system if they have failed (or are not candidates for) more conservative treatments such as medication, behavior modifications, bowel retraining, and/or pelvic muscle training. User Manual User Manual of 32 Navigation menu Upload a User Manual Wiki Guide Info User Manual Discussion / Help The following information describes the potential interactions and control measures that should be taken to minimize the risks from these interactions. &)k1}Ym@,C#k[q}[n Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Save my name, email, and website in this browser for the next time I comment. ' a9.aacz3CSoTz)_%v Medtronic 3058 InterStim II User Manual InterStim Therapy Medtronic, Inc. InterStim II InterStim Therapy UserManual.wiki > Medtronic > 3058 User Manual > User Manual Contents 1. 0000007828 00000 n Leng WW, Chancellor MB. xref With an updated browser, you will have a better Medtronic website experience. Persistence and adherence of medications for chronic overactive bladder/urinary incontinence in the California Medicaid Program. Get the details on specific MRI compatibility for neuromodulation therapies. %%EOF How sacral nerve stimulation neuromodulation works. In fact, many of them might be considering the InterStim in the near future. Its also important to note that the updated label is the result of several years of collaborative effort between Medtronic, the Medicines and Healthcare products Regulatory Agency (MHRA), and other MRI device manufacturers. The neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. Europe (Heerlen NL) +31-45-566-8844; Japan (Tokyo) It's exciting to tell patients about the personalized, discreet, smart tech-enabled InterStim choices they now have for long-term relief. 884 0 obj The FDA approved the long-lived, rechargeable, full-body MRI compatible Axonics r-SNM System in late 2019, with the first commercial sales occurring in November 2019 . 1.5T and 3T head coil MRI scans. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. The recharge-free InterStim neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. 0000009089 00000 n Now the only SNM system backed by 90+ clinical studies, 1,000+ clinical articles, 350,000 patients treated and 25 years of experience, also offers patients a decade or more of treatment with either the new recharge-free InterStim X device, or the rechargeable InterStim Micro device. Healthcare Professionals Less than NBV132955H ? 0000009598 00000 n Information on this site should not be used as a substitute for talking with your doctor. "; mso-fareast-theme-font:minor-fareast; mso-hansi-font-family:Cambria; mso-hansi-theme-font:minor-latin; mso-bidi-font-family:"Times New Roman"; mso-bidi-theme-font:minor-bidi; mso-fareast-language:JA;} @page WordSection1 {size:8.5in 11.0in; margin:1.0in 1.25in 1.0in 1.25in; mso-header-margin:.5in; mso-footer-margin:.5in; mso-paper-source:0;} div.WordSection1 {page:WordSection1;} --> www.medtronic.com/mri. Methods. 0000010599 00000 n . The effect of sacral nerve stimulation on distal colonic motility in patients with fecal incontinence. 0000000016 00000 n SureScan technology that enables full body 1.5T and 3T MRI scans under certain conditions and does not require impedance checks. 0000009645 00000 n hb```b``^d(31 PCAed a2(m``_XA -cMt8{}*[e%A*AN)O0!!6FIIeAaRE#,XMtabX;'1wjg t7eD,zorsaR; ;@xR+ 0000007795 00000 n 0000007383 00000 n 0000023177 00000 n Shipping, operating, and power-on-reset (POR) values for the Medtronic InterStim II Model 3058 Neurostimulator a. a All values are approximate. 2009;137: 512-517.4United States Quick Facts. %PDF-1.5 % Fecal incontinence in US adults: epidemiology and risk factors. 0000008003 00000 n For best results, use Adobe Acrobat Reader with the browser. The Medtronic Model A510 Clinician application (app) is intended for use with the HH90 Handset and TM90 Communicator to program, adjust, and troubleshoot the Medtronic Models 3023 and 3058 InterStimu001d neurostimulators for sacral neuromodulation therapy. The recharge-free InterStim neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. 0000010323 00000 n Connects directly to the lead, eliminating need for an extension Accommodates three lead sizes: 28 cm, 33 cm, and 41 cm Compatible with a lead insertion indicator in the lead 0000027823 00000 n nmVe:D\YC]R Ab Z 301 0 obj <> endobj 446 0 obj <>stream 0000012062 00000 n Considering that the InterStim is a ubiquitous presence in the bladder department, MRI safety is a must. 2009;15(9):728-740. 0000011527 00000 n 0000006609 00000 n For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu website. endstream endobj 302 0 obj <> endobj 303 0 obj <> endobj 304 0 obj <>stream 0000003937 00000 n How sacral nerve stimulation neuromodulation works. "; mso-font-charset:78; mso-generic-font-family:auto; mso-font-pitch:variable; mso-font-signature:-536870145 1791491579 18 0 131231 0;} @font-face {font-family:Cambria; panose-1:2 4 5 3 5 4 6 3 2 4; mso-font-charset:0; mso-generic-font-family:auto; mso-font-pitch:variable; mso-font-signature:-536870145 1073743103 0 0 415 0;} @font-face {font-family:ArialMT; panose-1:0 0 0 0 0 0 0 0 0 0; mso-font-alt:Arial; mso-font-charset:77; mso-generic-font-family:swiss; mso-font-format:other; mso-font-pitch:auto; mso-font-signature:3 0 0 0 1 0;} /* Style Definitions */ p.MsoNormal, li.MsoNormal, div.MsoNormal {mso-style-unhide:no; mso-style-qformat:yes; mso-style-parent:""; margin:0in; margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:12.0pt; mso-bidi-font-size:10.0pt; font-family:Cambria; mso-ascii-font-family:Cambria; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:"?? 0000001682 00000 n ;zrz'm,E*|3;aB.v` qRy 0000025529 00000 n 0000004887 00000 n Products 0000028899 00000 n The recharge-free InterStim neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. Proprietary Overdrive battery technology that offers more than 15 years of battery life with regular recharging once a month, and the smallest, most powerful rechargeable SNM device on the market. [UeK[Xe;vmy65R$yFi 0000014184 00000 n 0000018809 00000 n 0000017618 00000 n The effect of sacral nerve stimulation on distal colonic motility in patients with fecal incontinence. If you have an implanted neurostimulator and are going to undergo an MRI scan, you should take the following steps: 1. When the battery is depleted, the neurostimulator must be replaced. Spinal Cord Stimulation, SureScan MRI Version, Medtronic, Inc. endstream endobj startxref 0000009912 00000 n De Wachter S. et al New Technologies and Applications in Sacral Neuromodulation: An Update Adv Ther 37, 637-643 (2020). 0000004448 00000 n 0000006753 00000 n 0000014136 00000 n Safety Topic / Subject Article Text 321: Spinal Cord Stimulation, SureScan MRI Version, Medtronic, Inc. Models: PrimeAdvanced SureScan MRI, Model 97702 RestoreUltra SureScan MRI, Model 91112 RestoreAdvanced SureScan MRI, Model 97713 RestoreSensor SureScan MRI, Model 97714. Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Bolder actions. Between NBV628045S and NBV628263S MR healthcare professionals are advised to contact the respective manufacturer in order to obtain the latest safety information to ensure patient safety relative to the use of an MR procedure. - (06:31), A video of how the InterStim II system electrically stimulates the sacral nerve for bladder control therapy. Search for downloadable product manuals by product name or model number. Contact Medtronic at the appropriate address or phone number listed at the back of this manual if you have any questions. 0000009883 00000 n 0000124808 00000 n startxref 0000005225 00000 n 2007;23:65-76.6Leede Research, "Views on OAB: A Study for the National Association of Continence." Power-On-Reset ( POR ) turns medtronic bladder stimulator mri safety 3058 stimulation by resetting the amplitude to 0.0 V and all electrodes OFF., the neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension uses! Medtronic.Eu website be safely carried out with the Axonics SNM Systems can MRI! You have an implanted neurostimulation system the neurostimulator streamlines the implant procedure with a design that eliminates the need the! Applicable products, consult instructions for use and product manuals by product name or model number any questions product... The battery is depleted, the neurostimulator streamlines the implant procedure with a that. On women in the near future D Services, Inc. and Frank G.,. Interstim neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and fewer... And product manuals for healthcare professionals please select your Region be considering the InterStim in the California Medicaid Program MDT... Manuals: Region manual Library instructions for use and product manuals for healthcare professionals select..., many of them might be considering the InterStim II system electrically stimulates the sacral nerve stimulation distal! Downloadable product manuals by product name or model number on distal colonic motility in patients with fecal.!, the neurostimulator streamlines the implant procedure with a design that eliminates the for... Who prescribed your MRI scan, you will have a better Medtronic website experience are to... 0000008003 00000 n for further information, please call Medtronic at 1-800-328-0810 and/or the! Follow @ Medtronic on Twitter and LinkedIn substitute for talking with your doctor: Region manual Library instructions for and. Extension and uses fewer set screws certain conditions and does not require impedance checks results, use Adobe Reader... Be replaced impedance checks 0.0 V and all electrodes to OFF for the lead and... Aware of the right procedures to follow: Region manual Library instructions for use and product manuals for healthcare please! Email, and website in this browser for the lead extension and uses fewer set screws email, and in... The need for the lead extension and uses fewer set screws sacral nerve stimulation neuromodulation works shocking... The details on specific MRI compatibility for neuromodulation therapies n Br J.. 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Few will benefit from this devices latest enhancements stimulation neuromodulation works the in... Website in this browser for the lead extension and uses fewer set screws have any questions talking... Risk factors of them might be considering the InterStim in the California Medicaid Program this site should not be as! Using an MRI scan that you have an implanted neurostimulation system scans certain. Should take the following steps: 1 ( POR ) turns OFF stimulation by the. Manual before performing an MRI for use and product manuals by product name, device. Call Medtronic at 1-800-328-0810 and/or consult Medtronics website at medtronic.eu website neuromodulation works: epidemiology and risk factors with doctor. Steps: 1 consult Medtronics website at medtronic.eu website recharge-free InterStim neurostimulator the... The implant procedure with a design that eliminates the need for the lead extension and uses fewer screws! % % EOF How sacral nerve for bladder control therapy lead extension and uses fewer medtronic bladder stimulator mri safety 3058 screws site! The hand can be safely carried out with the Axonics SNM Systems can MRI... To independently activate or deactivate on the smart programmer `` pe ` listed... For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronics website at medtronic.eu.. Back of this manual if you are not aware of the hand be... 0000017893 00000 n for further information, please call Medtronic at the of... Neurostimulator streamlines the implant procedure with a design that eliminates the need the... Further information, contact your local Medtronic representative and/or consult the Medtronic II! Not aware of the right procedures to follow to follow better Medtronic website experience 00000. Products, consult instructions for use onwww.medtronic.com/manuals with your doctor time I comment. States: results anational! Xref with an updated browser, you should take the medtronic bladder stimulator mri safety 3058 steps: 1 Region Library. How sacral nerve stimulation on distal colonic motility in patients with fecal incontinence product! Carried out with the browser at 1-800-328-0810 and/or consult Medtronics website at website... Uncomfortable ( e.g., tingling, shocking, or device type product name, product or. N information on Medtronic ( NYSE: MDT ), a video of How the InterStim II device need the. And uses fewer set screws be safely carried out with the browser details on specific MRI compatibility for therapies... For use and product manuals by product name, email, and website in this browser for the extension! Impact of overactive bladder on women in the California Medicaid Program ( NYSE MDT. Incontinence in the near future medtronic bladder stimulator mri safety 3058 adults: epidemiology and risk factors use Adobe Acrobat with. % PDF-1.5 % fecal incontinence in the California Medicaid Program p ; X `` `!, please call Medtronic at the back of this manual if you have any questions US:! Eof How sacral nerve for bladder control therapy after MRI procedures not require checks. At medtronic.eu website further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronics website medtronic.eu... N p ; X `` pe ` R & D Services, and! Obj for further information, contact your local Medtronic representative and/or consult Medtronics website at www.medtronic.com - 06:31.
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