Current Medical Research and Opinion. Contact Medtronic at the appropriate address or phone number listed at the back of this manual if you have any questions. 0000009137 00000 n 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]_ endstream endobj startxref Hg1}Y@d3}quQ D~+ If you continue, you may go to a site run by someone else. Medicare and many other private insurance companies cover Medtronic Bladder Control Therapy. 2 InterStim Micro treats patients with overactive bladder, fecal incontinence, and non-obstructive urinary retention by delivering SNM therapy. Leng WW, Chancellor MB. Both devices are used in the treatment of overactive bladder (OAB), chronic fecal incontinence (FI), and non-obstructive urinary retention. These patients are considered suitable for the InterStim system once they havefailed or could not tolerate more conservative treatments. 0000005584 00000 n MRI of the hand can be safely carried out with the Medtronic Interstim II device. endstream endobj 307 0 obj <>stream POR can occur when there is a temporary fluctuation in battery voltage (eg . Leng WW, Chancellor MB. 0000023020 00000 n Contact Medtronic at the appropriate address or phone number listed at the back of this manual if you have any questions. This small electro-optical device is not only a cool-looking device, but it does not affect the quality of your MRI images. This site is Exclusively Sponsored by BRACCO. J Manag Care Pharm. The Axonics Sacral Neuromodulation (SNM) System is a sacral nerve stimulation (SNS) system that is intended to treat urinary retention and the symptoms of overactive bladder. 0000002263 00000 n 0000001682 00000 n Your doctor should discuss all potential benefits and risks with you. Update my browser now. These instructions do not apply to other implantable products, or other devices, products, or items. 0000014674 00000 n Information on this site should not be used as a substitute for talking with your doctor. Class 2 Device Recall InterStim (TM) System. Search by model name, product name, or device type. The Interstim II system may be suitable for most people because it's simple, convenient and lower maintenance.3. The only products we caution customers about are ones that are absorbable or drug coated. The first and only smart programmer - a programming device that looks like a common smartphone so patients may discreetly and independently adjust their choice of 11 therapy settings at home or on-the-go. The InterStim II system is the only recharge-free, long-termSNM system that lets you get full-body* MRI scans. 0000006938 00000 n 0000023883 00000 n MRI of the lumbar and pelvic regions with the Medtronic Interstim II (model 3058) stimulator has been shown to be safe. See approved labeling for details. In everything we do, we are engineering the extraordinary. stream 0000004713 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. ' a9.aacz3CSoTz)_%v HVI[1S#gUY9g- A7 RO$Z2NKHo-^]w_EjX1]2gm]dMj-Bm&*y, tum.5vam.q 6eHAUIIv1^xl-C`;"%Wl 0HC8h~cL! 0000026803 00000 n 0000006501 00000 n Under certain conditions; see approved labeling for details. Urological 0000124808 00000 n Products Under certain conditions. Tell the physician who prescribed your MRI scan that you have an implanted neurostimulation system. MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. 0000009645 00000 n Bladder Control Learn the parameters of patient selection for bladder control and bowel control. 0000008397 00000 n Our Mission to alleviate pain, restore health, and extend life unites a global team of 90,000+ passionate people across 150 countries. We do not review or control the content on non-Medtronic sites, and we are not responsible for any business dealings or transactions you have there. The good news is that many physicians are already familiar with the subject. 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). 1.5T and 3T upper and lower extremity MRI scans. 0000007383 00000 n p;X``pe`.)N]KA@!0834X@wP t(p 4qgp)h` j{ Some of these interactions, especially heating, are potentially hazardous and can lead to serious or permanent patient injury. {eH3zAsW[@9]E.}(ku4}0g{QsyzIOurFvDlM/6H7h*0ZZ5wp8'J={Z6yWkitXLq}l~Ke*Ra{6W"%{.N" %]B&m}AO_= W#aW&0]rPN1uyee9nOO(t.D00 1poJMWQBw)snRadpx.-` Z 0000013460 00000 n a)&|@a3ix g].3&^.jFMO5a For applicable products, consult instructions for use onwww.medtronic.com/manuals. %PDF-1.5 % Europe (Heerlen NL) +31-45-566-8844; Japan (Tokyo) "; 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:"?? 0000009089 00000 n The InterStim II system a recharge-free, long-term therapy that lets patients get full-body* MRI scans. %%EOF Eight MRI examinations at 1.5 Tesla were conducted in areas outside the pelvis on six patients with implanted sacral nerve stimulator (InterStim neurostimulator; Medtronic, Inc, Minneapolis, MN, USA). - (06:31), A video of how the InterStim II system electrically stimulates the sacral nerve for bladder control therapy. 0000004494 00000 n 2013;100:959968. For more information on Medtronic (NYSE:MDT), visit www.Medtronic.comand follow @Medtronic on Twitter and LinkedIn. 0000007795 00000 n 0000008003 00000 n 0000017893 00000 n 0000005793 00000 n Sacral Neuromodulation Systems This manual provides information for use in estimating battery longevity (the number of months or years that the Medtronic InterStim 3058 MRI safety is not just about making sure that you are using the right equipment. The neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. ", 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. Products 0000004045 00000 n Update my browser now. Urol Clin North Am. 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. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 0000004448 00000 n The InterStim II Model 3058 Neurostimulator is not rechargeable. endobj 0000016018 00000 n 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. 0000010041 00000 n 0000011240 00000 n InterStim systems are the standard of care in advanced therapy options, and the most personalized system, to deliver sacral neuromodulation (SNM) therapy. It is important to understand that ferromagnetic metals and metallic implants can be harmful if they move in the flight path of the MR scanner. 0000014136 00000 n 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. 2M XF"EEN"cL D3 0000027856 00000 n 0000006023 00000 n 0000018911 00000 n 0000007430 00000 n The effect of sacral nerve stimulation on distal colonic motility in patients with fecal incontinence. 0000013412 00000 n 0000018055 00000 n 0000008924 00000 n 0000027688 00000 n 0000010169 00000 n 0000006609 00000 n Important Safety Information, Medtronic Bladder Control Therapy delivered by the InterStim system, Medtronic Bladder Control Therapy delivered by the NURO system. 0000013358 00000 n Sacral Neuromodulation Systems Healthcare Professionals 446 0 obj <>stream startxref 0000000696 00000 n 0000018445 00000 n 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. Implanted pulse generators were examined before and after MRI procedures. Your use of the other site is subject to the terms of use and privacy statement on that site. 0000010275 00000 n 349 0 obj <>stream nmVe:D\YC]R Ab Z These instructions do not apply to other implantable products, or other devices, products, or items. 0000010503 00000 n For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu website. Actual results may differ materially from anticipated results. 0000011736 00000 n 0000018809 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. neurostimulator will provide stimulation at programmed settings before requiring recharge). 0000013017 00000 n 0000023686 00000 n 0000006985 00000 n This is important, as there are some very serious consequences if you are not aware of the right procedures to follow. Home MRI, inform the MRI technologist immediately and then contact your doctor. It is safe and effective. 2003 May;20(6):327-336.2United Nations, Department of Economic and Social Affairs, Population Division (2011). 0000008727 00000 n 0000010287 00000 n <> %%EOF 0000018755 00000 n 0000017618 00000 n Safety and effectiveness have not been established for pregnancy and delivery; patients under the age of 16; or for patients with neurological disease origins. ?? 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. 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. If using an MRI SureScan device, see the MRI SureScan technical manual before performing an MRI. REFERENCE