You must demonstrate an appropriate response to the evaluation to be a candidate. 0000023020 00000 n %%EOF 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. Click OK to confirm you are a Healthcare Professional. Home Contact Medtronic at the appropriate address or phone number listed at the back of this manual if you have any questions. ATTENTION: READ THE FULL LABELING FOR THIS INFORMATION BEFORE CONDUCTING AN MRI EXAMINATION IN A PATIENT WITH THIS DEVICE. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. 0000004887 00000 n 0000017228 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 0000007038 00000 n 0000005392 00000 n 756 0 obj The good news is that many physicians are already familiar with the subject. Prevalence and burden of overactive bladder in the United States. 0000013460 00000 n View MRI guidelines in the MRI Resource Library. If you have an implanted neurostimulator and are going to undergo an MRI scan, you should take the following steps: 1. Bladder Control He or she works closely with the MR medical director and MR safety officer. Patton V, Wiklendt L, Arkwright JW, Lubowski DZ, Dinning PG. 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. 0000012617 00000 n Axonics SNM Systems are MRI conditionally safe for: 1.5T and 3T full-body MRI scans. MRI mode is easy for patients to independently activate or deactivate on the smart programmer. endobj NEUROSTIMULATION SYSTEM: INTERSTIM THERAPY SACRAL NERVE STIMULATION (SNS) FOR URINARY CONTROL MRI Guidelines for InterStim Therapy Neurostimulation Systems MR Scanning Conditions MR Conditional: Non-clinical testing has demonstrated that InterStim Therapy systems have been found to be MR Conditional. 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. 0000011527 00000 n 0000004713 00000 n With low energy settings, the device may last up to 15 years. 0000004045 00000 n These instructions do not apply to other implantable products, or other devices, products, or items. 0000010222 00000 n nmVe:D\YC]R Ab Z 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. 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. Important note: Each device ind. 0000026803 00000 n 0000008350 00000 n 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. Aside from the aforementioned medical conditions, there is no shortage of people with urinary tract infections (UTIs). The InterStim II system is the only recharge-free, long-termSNM system that lets you get full-body* MRI scans. 0000018959 00000 n 0000027823 00000 n <> aiip ,@+er(Na[SI]$H-Gje*E q9L-k#:yDY$81*vw*h 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. However, several studies have shown no serious adverse outcomes. 0000006555 00000 n 0000014626 00000 n See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. Although many patients may benefit from the use of these treatments, results may vary. 0000005793 00000 n Contact Medtronic at the appropriate address or phone number listed at the back of this manual if you have any questions. Shipping, operating, and power-on-reset (POR) values for the Medtronic InterStim II Model 3058 Neurostimulator a. a All values are approximate. 0000013412 00000 n In August 2020, the FDA approved the InterStim Micro neurostimulator and InterStim SureScan MRI leads for the treatment of patients with bladder and bowl control conditions. endstream endobj startxref endstream endobj 307 0 obj <>stream We are Medtronic. 0000018911 00000 n xref In everything we do, we are engineering the extraordinary. Y{p._(u[(|{-[=Wbx7TJCvSVvjiTB.|Ug`~w|#U5IkGYdh38Y. 0000008298 00000 n 0000010041 00000 n 0000013304 00000 n 2013;100:959968. This contraindication was due to heating of the electrodes, which could damage neural tissue. More information (see more) 0000006985 00000 n y=9iK}xxyC]i2q~6KoNXqUDLJoNCk/_/y@6,6)SuMA<8XUJa!,kW0@'.I*'EluWII)4c1jG2,AAz(e`a`P@9dEb1 B2QPHbD (lT 0000025647 00000 n 323 0 obj <>/Filter/FlateDecode/ID[<28836736925E656CEC1D4A45F6B26EFC><9F3AF6A1190447458124BACAF1002E60>]/Index[301 49]/Info 300 0 R/Length 113/Prev 1197727/Root 302 0 R/Size 350/Type/XRef/W[1 3 1]>>stream 0000004995 00000 n Serial numbers ineligible for MRI scans (Model 3023 Neurostimulator only) Due to increased risk of neurostimulator damage, patients implanted with InterStim Model 3023 Neurostimulators with the following serial numbers should not have MRI scans: ? 0000018055 00000 n <> I~!#N*~aw+*EtOb_WF[#NEf0S)$9>! The Medtronic InterStim II Model 3058 Neurostimulator is used with a lead and the Medtronic InterStim Model 3023 Neurostimulator is used with a lead and an . Under certain conditions. 0000009182 00000 n Gastroenterology. The Medtronic 3058 Interstim II system delivers sustained improvements in quality of life for people with overactive bladder (OAB), non-obstructive urinary retention, and chronic fecal incontinence (FI). Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced it received approval from the U.S. Food and Drug Administration (FDA) for InterStim X the next generation DUBLIN, Feb. 22, 2022 /PRNewswire/ --Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced it received approval from the U.S. Food and Drug Administration (FDA) for InterStim X the next generation of the InterStim portfolio's recharge-free device and it is available immediately. Pelvic floor disorders network. World J Urol. neurostimulator will provide stimulation at programmed settings before requiring recharge). Medtronic Bladder Control Therapy delivered by the InterStim system treats urinary retention (inability to completely empty the bladder) and the symptoms of overactive bladder, including urinary urge incontinence (leakage) and significant symptoms of urgency-frequency. ?? This includes a new B1+rms technology for 1.5Tesla scans, and an updated label that adds more flexibility to clinicians practices. Regulatory Statements 2. 0000000016 00000 n Available at: https://www.census.gov/quickfacts/table/ PST045215/00. 0000006023 00000 n Proprietary 5th generation battery chemistry that offers more than 10 years of battery life without the need to recharge, providing patients with more freedom and less maintenance. Unintended Stimulation MRI may cause unintended stimulation from the implant. 0000018197 00000 n "This is not your grandmother's therapy. JbN}&Kt]FV~Uj_JK p a4! :}\ UxIM#ufX'z4WcHqFtEmXO0Su_[q/]&SZhz19>uK$V4} 1 kG,M^jaRv,gIvO& +x4pU.Vw 33/Ax/M>s["-89@ S$}D l~v626Zr 6o2ulSs?z=^!e/(k&zbxgn-p]o`vl@mv9670>=/o.HU}d~z6X{icp{y X]_ Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Healthcare Professionals Always talk with your doctor about diagnosis and treatment information. Medtronic plc, headquartered in Dublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. 0000025277 00000 n Exercise caution for patients with heart problems. THE LATEST INFORMATION MAY BE OBTAINED FROM www.medtronic.com/mri MRI and InterStim Therapy It is important to read this information in its entirety before conducting a magnetic resonance imaging (MRI) head scan on a patient with any implanted component of a Medtronic InterStim Therapy neurostimulation system. 0000006501 00000 n A patient implanted with the Axonics SNM Systems can undergo MRI examinations safely under the conditions . 0000124808 00000 n You cannot have diathermy (deep heat treatment from electromagnetic energy) if you have an InterStim device. Between NBV133037H and NBV133063H ? 0000018755 00000 n 0000011736 00000 n xUMHTQ=gS?X J"!sR$$JQH]"(AAPHm@D1DE6y|#Asw;J a)&|@a3ix g].3&^.jFMO5a It uses an implanted stimulator to deliver electrical pulses through a lead wire to electrodes located near the sacral nerve. 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 . Considering that the InterStim is a ubiquitous presence in the bladder department, MRI safety is a must. 0000005584 00000 n 446 0 obj <>stream hb```f``:2AX, N qx|lPl!X42p)q9s%n@VMtCTHzOw]o^Z)jhUos'd/m$-jcaVpM;;;::%\ 02," @ANNbb@, ~k]hz$Mp 0000016458 00000 n These treatments are prescribed by your doctor. 0000008003 00000 n "; 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:"?? 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. Search by model name, product name, or device type. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. These patients are considered suitable for the InterStim system once they havefailed or could not tolerate more conservative treatments. Learn how to turn the InterStim neurostimulator on and off with a Interstim iCon programmer.If you've tried other treatments but are still suffering from bla. igXOs!i']}E]Zxu#udHK}}{wMW~ia>=ekO zw,a_MfT\R "}con}l%BU?8>`MO{zcIRv2P,k{fXY0p0iX}Tk([orZjZEsh)v0:oHcg[_3/BX\>_7#-nLo.bpoUu~vwX"h 1Pc=r"5(K^4I@@G'AE*p N It's exciting to tell patients about the personalized, discreet, smart tech-enabled InterStim choices they now have for long-term relief. In addition to risks related to surgery, complications can include pain at the implant sites, new pain, infection, lead (thin wire) movement/migration, device problems, interactions with certain other devices or diagnostic equipment such as MRI, undesirable changes in urinary or bowel function, and uncomfortable stimulation (sometimes described as a jolting or shocking feeling). It is also about being aware of the proper way to conduct your exams and to ensure the safety of everyone involved. Rh)b#0a(Z)#!H Bb*acH@L Q 9 , p043/aeSe3JEANr3>-u8wFXGp. ?? For more information on Medtronic (NYSE:MDT), visit www.Medtronic.comand follow @Medtronic on Twitter and LinkedIn. +yLKxN5F`W82r Patients InterStim Therapy for Urinary Control (Medtronic, Inc., Minneapolis, MN), Neurostimulation System, Non-clinical testing has demonstrated that InterStim Therapy, systems have been found to be MR Conditional. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. ;zrz'm,E*|3;aB.v` qRy For best results, use Adobe Acrobat Reader with the browser. This therapy ismost appropriatefor bowel control patients who: This therapy isnot appropriatefor bowel control patients who: In Perfect sealed condition but past expiration date. "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. 1Stewart WF, et al. 0000010169 00000 n Some of these interactions, especially heating, are potentially hazardous and can lead to serious or permanent patient injury. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Recharge-free neurostimulator for bladder and bowel control, 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, 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, Incorporates radiopaque identification of manufacturer and model number, Allows full-body MRI scans for patients who need them*, InterStim SureScan MRI lead model 978B1. 0000000696 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 0000018809 00000 n 2003 May;20(6):327-336.2United Nations, Department of Economic and Social Affairs, Population Division (2011). Urol Clin North Am. 0000010106 00000 n 0000002333 00000 n In summary, we can say the following about Medtronic InterStim 3058 MRI Safety; MRI of the lumbar and pelvic areas with the InterStim II device can be performed safely, as long as the patient is positioned correctly. With an updated browser, you will have a better Medtronic website experience. Leng WW, Chancellor MB. Actual results may differ materially from anticipated results. Br J Surg. 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.