medtronic bladder stimulator mri safety 3058

0000000696 00000 n The neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. Both devices are used in the treatment of overactive bladder (OAB), chronic fecal incontinence (FI), and non-obstructive urinary retention. See approved labeling for details. Sacral Neuromodulation Systems 0000007625 00000 n HVI[1S#gUY9g- A7 RO$Z2NKHo-^]w_EjX1]2gm]dMj-Bm&*y, tum.5vam.q 6eHAUIIv1^xl-C`;"%Wl 0HC8h~cL! 0000004045 00000 n Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification. 2003 May;20(6):327-336.2United Nations, Department of Economic and Social Affairs, Population Division (2011). 0000023177 00000 n hb```f``:2AX, N qx|lPl!X42p)q9s%n@VMtCTHzOw]o^Z)jhUos'd/m$-jcaVpM;;;::%\ 02," @ANNbb@, ~k]hz$Mp Specifically, these guidelines expand the range of MRI scan parameters that clinicians can use, allowing them to offer patients with InterStim devices a wider array of MRI procedures. <<8176020B0CB4AE4A9F0BF88D5F2A90DE>]/Prev 621018>> The implanted InterStim II system electrically stimulates the sacral nerve, which is thought to normalise neural communication between the bladder and brainand between the bowel and brain.1,2, Medtronic Bladder Control Therapy 2. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. p;X``pe`.)N]KA@!0834X@wP t(p 4qgp)h` j{ 9>sa6 ~Ay@Z/l^/!6pLb+{Mk 0000023451 00000 n /mBJ-tX/nk}I_.MRs4_ Z@`XJ$ lg~DDL^8!p4-T *\&NTok*^e\zU>ZaSF8"dyJ,rq)9\v67#FQ|FCYH !y+*12p1dbKj)(Ljg7S InterStim II. Accessed July 19, 2016.5Dmochowski RR, Newman DK. 0000009830 00000 n 0000012610 00000 n 2013;100:959968. Europe (Heerlen NL) +31-45-566-8844; Japan (Tokyo) Br J Surg. 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. Pelvic floor disorders network. Patients with InterStim MRI Leads only. 0000006985 00000 n When the battery is depleted, the neurostimulator must be replaced. Actual results may differ materially from anticipated results. Magnetic Resonance Imaging (MRI) Guidelines for the Axonics System. 2005;32:11-18. 0000023719 00000 n The manufacturers sterilize the products after they are packaged and it lasts so many years. Persistence and adherence of medications for chronic overactive bladder/urinary incontinence in the California Medicaid Program. Update my browser now. 0000014238 00000 n Several precautions should be taken, including selecting the appropriate coil and positioning the patient outside the MRI scanner room. The following information describes the potential interactions and control measures that should be taken to minimize the risks from these interactions. 0000023686 00000 n 0000065437 00000 n ;zrz'm,E*|3;aB.v` qRy Medicare and many other private insurance companies cover Medtronic Bladder Control Therapy. <> 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). MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. Less information (see less). 0000010287 00000 n Value in Health. He or she works closely with the MR medical director and MR safety officer. 0000005846 00000 n 301 0 obj <> endobj 0000018959 00000 n Methods: Eight MRI examinations at 1.5Tesla were conducted in areas outside the pelvis on six patients with implanted sacral nerve stimulator (InterStim neurostimulator; Medtronic, Inc, Minneapolis, MN, USA). For applicable products, consult instructions for use onwww.medtronic.com/manuals. These updates also allow for a shorter waiting time between MRI scans. These patients are considered suitable for the InterStim system once they havefailed or could not tolerate more conservative treatments. 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 . 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. 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. 0000004467 00000 n 0000005793 00000 n Urol Clin North Am. 0000027445 00000 n 2007;23:65-76.6Leede Research, "Views on OAB: A Study for the National Association of Continence." This unintended stimulation may be uncomfortable (e.g., tingling, shocking, or jolting). Under certain conditions. 0000013304 00000 n 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 . Medtronic 3058 Interstim II Neurostimulator for Bladder and Bowel Control. 0000008003 00000 n 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. There have been few studies evaluating the risk of MRI in patients with this implant. 0000017618 00000 n Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. If you continue, you may go to a site run by someone else. Home "As we celebrate 25 years of InterStim this year, we're bullish about our next chapter in patient-focused therapy innovation. Contact Medtronic at the appropriate address or phone number listed at the back of this manual if you have any questions. With low energy settings, the device may last up to 15 years. 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. 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 0000013358 00000 n 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. InterStim II Model 3058 Neurostimulator Table 1. Patients with InterStim SureScan MRI leads only. With an updated browser, you will have a better Medtronic website experience. 0000025529 00000 n 0000027856 00000 n Medtronic Manuals: Region Manual Library Instructions for use and product manuals for healthcare professionals Please select your region. 1.5T and 3T upper and lower extremity MRI scans. In order to ensure safety in MR facilities, all personnel involved must understand safety procedures and be willing to communicate with each other. 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. 0000008245 00000 n 0000010275 00000 n Fecal incontinence in US adults: epidemiology and risk factors. We are Medtronic. %%EOF This is important, as there are some very serious consequences if you are not aware of the right procedures to follow. ", More than 37 million adults in the United States almost one in six suffer from overactive bladder (OAB),1,2 and nearly 18 million Americans about one in 12 are living with fecal incontinence.3,4 Many sufferers limit their lives socially, professionally, and personally.5 However, as many as 45% who suffer from symptoms do not seek treatment and as many as seven in 10 stop using medications within six months due to intolerable side effects or unsatisfying results.6,7,8. Adverse events are typically temporary, and include mild pain, minor inflammation and bleeding near treatment site. Tell the physician who prescribed your MRI scan that you have an implanted neurostimulation system. Many patients with OAB or retention have poor or reduced quality of life because of their symptoms. "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. Our Mission to alleviate pain, restore health, and extend life unites a global team of 90,000+ passionate people across 150 countries. 427 0 obj <> endobj For best results, use Adobe Acrobat Reader with the browser. These therapies are not for everyone. 0000012014 00000 n b Power-on-reset (POR) turns OFF stimulation by resetting the amplitude to 0.0 V and all electrodes to OFF. H\V7+KJ}Rs%0+JiRJ!sC[ySsLj5I/y]bqUG22&~[kWq4 @|K 0,.KKm[[E|B~\'[$NX!c3g{1-AbgQ`(3#DKp~y7GxR"X dq&+iUXN}YE2Q1G,Zr~8u"O{th8V*UQQZ [Ib"t/ hWy/__/~~r|?V%Kwp>#}TXXTP3gT9!yka X1'J$z"+vn~[i S+~nhaRUn+k]SY *%4rv),^-u`3t8qgtsm,).c3Dn #,3iP'[. 0000004713 00000 n 0000010041 00000 n Get the details on specific MRI compatibility for neuromodulation therapies. 0000000016 00000 n The InterStim II Model 3058 Neurostimulator is not rechargeable. These components are well depicted on a standard radiograph. 756 0 obj The new Medtronic scanning parameters 1 increases SAR limits for 1.5 Tesla scans from 0.5 W/kg to 2.0 W/kg; and for 3 Tesla scans from 0.5 W/kg to 1.4 W/kg. ATTENTION: READ THE FULL LABELING FOR THIS INFORMATION BEFORE CONDUCTING AN MRI EXAMINATION IN A PATIENT WITH THIS DEVICE. 0000008727 00000 n 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. 0000012562 00000 n Medtronic Interstim 3058 MRI Safety MRI of the hand MRI of the hand can be safely carried out with the Medtronic Interstim II device. 0000013460 00000 n For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronics website at www.medtronic.com. 0000028229 00000 n All patients had their parameters recorded; then the IPGs were put to "nominal" status. 0000015970 00000 n Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. 0000008679 00000 n 0000016362 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. 446 0 obj <>stream See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. 0000006938 00000 n 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. %PDF-1.3 % 0000009458 00000 n Leng WW, Chancellor MB. hVmO8+j-oVH%v!Rno"dR/6M]q&PeY3gI"C%L)|"=9}Hp9>.H/)")KK0 AI>sOX$fEF\E\y [> Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 2005;8(4)495-505.8Yeaw J, Benner JS, Walt JG, Sian S, Smith DB, et al. 0000017893 00000 n 0000000016 00000 n 0000009782 00000 n . 0000018863 00000 n Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. World Population Prospects: The 2010 Revision, CD-ROM Edition.3Whitehead WE, Borrud L, Goode PS, et al. Exercise caution for patients with heart problems. The effect of sacral nerve stimulation on distal colonic motility in patients with fecal incontinence. startxref 0000017228 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. "This is not your grandmother's therapy. The new labeling also decreases wait time from 60 minutes to 5 minutes for maximum duration scans (30 minutes). 0000008051 00000 n The Interstim II system may be suitable for most people because it's simple, convenient and lower maintenance.3. %%EOF 0000026803 00000 n 5Z\&l:|iXeMt+Z5|L| 1v 3tT#`K?FWrS8% Rh)b#0a(Z)#!H Bb*acH@L Q 9 , p043/aeSe3JEANr3>-u8wFXGp. Healthcare Professionals Ll2@108 y=9iK}xxyC]i2q~6KoNXqUDLJoNCk/_/y@6,6)SuMA<8XUJa!,kW0@'.I*'EluWII)4c1jG2,AAz(e`a`P@9dEb1 B2QPHbD (lT MRI of the hand can be safely carried out with the Medtronic Interstim II device. Important Safety Information, Medtronic Bladder Control Therapy delivered by the InterStim system, Medtronic Bladder Control Therapy delivered by the NURO system. Bolder actions. Impact of overactive bladder on women in the United States: results of anational survey. MR safety expert is a person who is responsible for developing a local and safe MR safety framework. The good news is that many physicians are already familiar with the subject. 0000004494 00000 n 0000006184 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: ? 0000001914 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. He or she also provides advice on non-routine MR procedures. The InterStim II system a recharge-free, long-term therapy that lets patients get full-body* MRI scans. ", "We're on a mission to expand access to proven nerve stimulation therapies through technology advancements like InterStim X, InterStim Micro, SureScan MRI technology and the smart programmer, by offering patients personalized therapy options and by reaching them through direct-to-consumer marketing," said Mira Sahney, president of the Pelvic Health business, which is part of the Neuroscience Portfolio at Medtronic. Between NBV133037H and NBV133063H ? Gastroenterology. 0000010551 00000 n 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. 0000009912 00000 n 0000011240 00000 n 0000016706 00000 n 0000012617 00000 n Due to increased risk of neurostimulator damage, patients implanted with InterStim Model 3023 Neurostimulators with the following serial numbers should not have MRI scans. 0000006657 00000 n 0000003266 00000 n }$Y? 0000028899 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:"?? %%EOF This includes a new B1+rms technology for 1.5Tesla scans, and an updated label that adds more flexibility to clinicians practices. Not for human use in the US. The Subcutaneous Electro-optical Crystal (SEC) has an electro-optical crystal that changes refractive indexes depending on the applied E-field. The clinician uses the Clinician app to . How sacral nerve stimulation neuromodulation works. Hg1}Y@d3}quQ D~+ 0000017570 00000 n Update my browser now. Patton V, Wiklendt L, Arkwright JW, Lubowski DZ, Dinning PG. Although many patients may benefit from the use of these treatments, results may vary. &)k1}Ym@,C#k[q}[n 0000018445 00000 n 0000014136 00000 n 0000009883 00000 n Under certain conditions; see approved labeling for details. Aside from the aforementioned medical conditions, there is no shortage of people with urinary tract infections (UTIs). Bladder Control This small electro-optical device is not only a cool-looking device, but it does not affect the quality of your MRI images. However, several studies have shown no serious adverse outcomes. 0000004995 00000 n 0000018547 00000 n 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. The implanted InterStim II system electrically stimulates the sacral nerve, which is thought to normalize neural communication between the bladder and brainand between the bowel and brain.1,2, Medtronic Bladder Control Therapy This manual provides information for use in estimating battery longevity (the number of months or years that the 0000011527 00000 n That said, you have to ask yourself, are you a patient? HUMs6Wlo86;L,fzJTI4 i&p\}xX.@1Tn`}!a[z$WC@WH0)zK61xD"6Vqyu*^pJ3hAX638}Iv=M$ ZDp`2fK3F_E} J jV?hOS1Eg{y 0000007828 00000 n 1-(800)-723-4636 (Tachy) 1-(800)-505-4636 (Brady) International Technical Centers. Learn the parameters of patient selection for bladder control and bowel control. 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. Your use of the other site is subject to the terms of use and privacy statement on that site. 0000014626 00000 n 0000016308 00000 n It is possible that some of the products on the other site are not approved in your region or country. 0000009089 00000 n a)&|@a3ix g].3&^.jFMO5a In fact, many of them might be considering the InterStim in the near future. How sacral nerve stimulation neuromodulation works. Update my browser now. MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. Questions and Answers in MRI - MRI Questions & Answers; MR imaging . The Interstim II device can be safely scanned at 1.5 T. However, to safely achieve this feat, it is important to choose a suitable coil, use a corresponding hand coil, and position the patient in a way that minimizes the likelihood of heating. 349 0 obj <>stream 0000006753 00000 n endstream endobj 307 0 obj <>stream 1.5T and 3T head coil MRI scans. Some of these interactions, especially heating, are potentially hazardous and can lead to serious or permanent patient injury. It is safe and effective. 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. 2009;15(9):728-740. Considering that the InterStim is a ubiquitous presence in the bladder department, MRI safety is a must. 0000008397 00000 n InterStim II. 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 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. You cannot have diathermy (deep heat treatment from electromagnetic energy) if you have an InterStim device. However, it is important to consider the risk posed by your specific MRI scan parameters. Please talk to your doctor to decide whether these therapies are right for you. xref I~!#N*~aw+*EtOb_WF[#NEf0S)$9>! 0000005584 00000 n Important note: Each device ind. endobj ?? 0000010599 00000 n Treatments & Therapies Leng WW, Chancellor MB. 0000003363 00000 n 0000018245 00000 n 0000001682 00000 n 0000011431 00000 n It is important to read this information in its entirety before conducting a magnetic resonance imaging (MRI) head scan on a patient with any implanted component of a Medtronic InterStim Therapy neurostimulation system. 0000025647 00000 n Products You must demonstrate an appropriate response to the evaluation to be a candidate. Axonics SNM Systems are MRI conditionally safe for: 1.5T and 3T full-body MRI scans. 0000012062 00000 n Available at: https://www.census.gov/quickfacts/table/ PST045215/00. 0000009993 00000 n xref Some of these interactions, especially heating, are potentially hazardous and can lead to serious or permanent patient injury. Central/Eastern Europe, Middle East & Africa, Connects directly to the lead, eliminating need for an extension, Accommodates three lead sizes: 28 cm, 33 cm, and 41 cm, Compatible with a lead insertion indicator in the lead, Incorporates radiopaque identification of manufacturer and model number, InterStim SureScan MRI lead model 978B1. JbN}&Kt]FV~Uj_JK p a4! :}\ UxIM#ufX'z4WcHqFtEmXO0Su_[q/]&SZhz19>uK$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]_ ?? It's exciting to tell patients about the personalized, discreet, smart tech-enabled InterStim choices they now have for long-term relief. It should be used after you have tried other treatments such as medications and behavioral therapy and they have not worked, or you could not tolerate them. m The InterStim II system is the only recharge-free, long-termSNM system that lets you get full-body* MRI scans. Less information (see less). "; 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; mso-no-proof:yes;} .MsoChpDefault {mso-style-type:export-only; mso-default-props:yes; font-size:10.0pt; mso-ansi-font-size:10.0pt; mso-bidi-font-size:10.0pt; font-family:Cambria; mso-ascii-font-family:Cambria; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:"?? In addition, a thorough investigation must be conducted before any MR equipment is placed in a facility. In everything we do, we are engineering the extraordinary. Unintended Stimulation MRI may cause unintended stimulation from the implant. 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. REFERENCE