0000004467 00000 n Shipping, operating, and power-on-reset (POR) values for the Medtronic InterStim II Model 3058 Neurostimulator a. a All values are approximate. Although many patients may benefit from the use of these treatments, results may vary. Medtronic Bladder Control Therapy delivered by the NURO system treats overactive bladder and associated symptoms of urinary urgency, urinary frequency, and urge incontinence. In order to ensure safety in MR facilities, all personnel involved must understand safety procedures and be willing to communicate with each other. 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 We are Medtronic. Accessed July 19, 2016.5Dmochowski RR, Newman DK. 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. 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. Sacral Neuromodulation Systems These patients are considered suitable for the InterStim system once they havefailed or could not tolerate more conservative treatments. 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). %PDF-1.5 % 0000009089 00000 n 0000012617 00000 n Br J Surg. 0000005225 00000 n SureScan technology that enables full body 1.5T and 3T MRI scans under certain conditions and does not require impedance checks. 756 129 Historically, patients with implantable SNM devices have been contraindicated for MRI. 0000005793 00000 n Exercise caution for patients with heart problems. Sacral Neuromodulation Systems 0000016308 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. Medtronic 3058 InterStim II User Manual InterStim Therapy Medtronic, Inc. InterStim II InterStim Therapy UserManual.wiki > Medtronic > 3058 User Manual > User Manual Contents 1. About MedtronicBold thinking. 0000018197 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. 0000027856 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 0000028899 00000 n hVmO8+j-oVH%v!Rno"dR/6M]q&PeY3gI"C%L)|"=9}Hp9>.H/)")KK0 AI>sOX$fEF\E\y [> 0000010275 00000 n {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 0000008954 00000 n This unintended stimulation may be uncomfortable (e.g., tingling, shocking, or jolting). 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. 2003 May;20(6):327-336.2United Nations, Department of Economic and Social Affairs, Population Division (2011). 0000008298 00000 n y=9iK}xxyC]i2q~6KoNXqUDLJoNCk/_/y@6,6)SuMA<8XUJa!,kW0@'.I*'EluWII)4c1jG2,AAz(e`a`P@9dEb1 B2QPHbD (lT 2013;100:959968. If you continue, you may go to a site run by someone else. United States Census Bureau Web site. The new guidelines add to Medtronics existing MRI label, which includes a comprehensive MRI Safety Guidance. See approved labeling for details. MRI of the hand can be safely carried out with the Medtronic Interstim II device. For more information on Medtronic (NYSE:MDT), visit www.Medtronic.comand follow @Medtronic on Twitter and LinkedIn. 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. neurostimulator will provide stimulation at programmed settings before requiring recharge). Current Medical Research and Opinion. Update my browser now. 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$}D l~v626Zr 6o2ulSs?z=^!e/(k&zbxgn-p]o`vl@mv9670>=/o.HU}d~z6X{icp{y X]_ 0000012800 00000 n 0000019081 00000 n The effect of sacral nerve stimulation on distal colonic motility in patients with fecal incontinence. He or she works closely with the MR medical director and MR safety officer. However, if the conditions for safe MRI are Leng WW, Chancellor MB. HVI[1S#gUY9g- A7 RO$Z2NKHo-^]w_EjX1]2gm]dMj-Bm&*y, tum.5vam.q 6eHAUIIv1^xl-C`;"%Wl 0HC8h~cL! aiip ,@+er(Na[SI]$H-Gje*E q9L-k#:yDY$81*vw*h ", "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. 0000005846 00000 n A patient implanted with the Axonics SNM Systems can undergo MRI examinations safely under the conditions . 0000014184 00000 n 0000124808 00000 n 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. 0000015970 00000 n 0000025647 00000 n 0000023883 00000 n Spinal Cord Stimulation, SureScan MRI Version, Medtronic, Inc. b Power-on-reset (POR) turns OFF stimulation by resetting the amplitude to 0.0 V and all electrodes to OFF. 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. 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. 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 . 0000012562 00000 n 0000000016 00000 n Those lucky few will benefit from this devices latest enhancements. xref 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. startxref 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). 0000018445 00000 n This small electro-optical device is not only a cool-looking device, but it does not affect the quality of your MRI images. 0000009137 00000 n 2005;8(4)495-505.8Yeaw J, Benner JS, Walt JG, Sian S, Smith DB, et al. 0000023020 00000 n 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. Manuals can be viewed using a current version of any major internet browser. hbbd```b``^"w L 5(09"z@d)6yd&` e:S&F=`iE 2. %%EOF He or she also provides advice on non-routine MR procedures. If you are a doctor, you should be familiar with MRI safety guidelines. 0000016410 00000 n Not for human use in the US. Actual results may differ materially from anticipated results. Value in Health. 0000014402 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 . HUMs6Wlo86;L,fzJTI4 i&p\}xX.@1Tn`}!a[z$WC@WH0)zK61xD"6Vqyu*^pJ3hAX638}Iv=M$ ZDp`2fK3F_E} J jV?hOS1Eg{y The InterStim II system a recharge-free, long-term therapy that lets patients get full-body* MRI scans. It uses an implanted stimulator to deliver electrical pulses through a lead wire to electrodes located near the sacral nerve. 0000010551 00000 n MRI: Testing of the VOCARE Bladder System/Finetech-Brindley Bladder System (Vocare) in a 1.5-Tesla scanner with a maximum spatial gradient of 450 gauss/cm or less, exposed to an average Specific Absorption Rate (SAR) of 1.1 W/kg, for a 30 minute duration resulted in localized temperature rises up to 5.5?C in a gel phantom (without blood flow . 0000018547 00000 n Healthcare Professionals With an updated browser, you will have a better Medtronic website experience. +yLKxN5F`W82r The Global Unique Device Identification Database (GUDID) contains key device identification information submitted to the FDA about medical devices that have Unique Device Identifiers (UDI). 0000014136 00000 n Please talk to your doctor to decide whether these therapies are right for you. I~!#N*~aw+*EtOb_WF[#NEf0S)$9>! This therapy isappropriatefor bladder control patients who: This therapy isnot appropriatefor bladder control patients who: Many patients with chronic FI have poor or reduced quality of life because of their symptoms. ATTENTION: READ THE FULL LABELING FOR THIS INFORMATION BEFORE CONDUCTING AN MRI EXAMINATION IN A PATIENT WITH THIS DEVICE. DUBLIN, Feb. 22, 2022 /PRNewswire/ -- Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced it received approval from the U.S. Food and Drug Administration (FDA) for InterStim X the next generation of the InterStim portfolio's recharge-free device - and it is available immediately. The recharge-free InterStim neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. endstream endobj 306 0 obj <>stream 0000005583 00000 n 0000005584 00000 n /mBJ-tX/nk}I_.MRs4_ Z@`XJ$ lg~DDL^8!p4-T *\&NTok*^e\zU>ZaSF8"dyJ,rq)9\v67#FQ|FCYH !y+*12p1dbKj)(Ljg7S 0000003266 00000 n Patients with InterStim SureScan MRI leads only. 0000010287 00000 n 0000007430 00000 n 0000009598 00000 n 0000008245 00000 n 0000024733 00000 n 0000017570 00000 n 0000004448 00000 n Persistence and adherence of medications for chronic overactive bladder/urinary incontinence in the California Medicaid Program. More information (see more) 0000007828 00000 n Contact Medtronic at the appropriate address or phone number listed at the back of this manual if you have any questions. 1Stewart WF, et al. Axonics SNM Systems are MRI conditionally safe for: 1.5T and 3T full-body MRI scans. 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. This contraindication was due to heating of the electrodes, which could damage neural tissue. Europe (Heerlen NL) +31-45-566-8844; Japan (Tokyo) 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 Subcutaneous Electro-optical Crystal (SEC) has an electro-optical crystal that changes refractive indexes depending on the applied E-field. Both devices are used in the treatment of overactive bladder (OAB), chronic fecal incontinence (FI), and non-obstructive urinary retention. The Interstim II system may be suitable for most people because it's simple, convenient and lower maintenance.3. 0000009883 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 0000041486 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. If you have an implanted neurostimulator and are going to undergo an MRI scan, you should take the following steps: 1. It's exciting to tell patients about the personalized, discreet, smart tech-enabled InterStim choices they now have for long-term relief. Leng WW, Chancellor MB. 0000004887 00000 n Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 0000008625 00000 n 0000004713 00000 n This is important, as there are some very serious consequences if you are not aware of the right procedures to follow. MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. 0000009782 00000 n How sacral nerve stimulation neuromodulation works. With an updated browser, you will have a better Medtronic website experience. 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. endstream endobj 428 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. "This is not your grandmother's therapy. 0000011083 00000 n In addition, a thorough investigation must be conducted before any MR equipment is placed in a facility. Search by model name, product name, or device type. De Wachter S. et al New Technologies and Applications in Sacral Neuromodulation: An Update Adv Ther 37, 637-643 (2020). 0000018493 00000 n 4.2. "As we celebrate 25 years of InterStim this year, we're bullish about our next chapter in patient-focused therapy innovation. <> ;zrz'm,E*|3;aB.v` qRy 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. 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 Interstim II device can be safely scanned at 1.5 T. &)k1}Ym@,C#k[q}[n Bladder Control Aside from the aforementioned medical conditions, there is no shortage of people with urinary tract infections (UTIs). The neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. 0000012062 00000 n 0000015308 00000 n However, several studies have shown no serious adverse outcomes. 0000002333 00000 n <<643BDC4F02F463BA264A9A2366C35000>]>> Impact of overactive bladder on women in the United States: results of anational survey. Treatments & Therapies Information on this site should not be used as a substitute for talking with your doctor. 2 InterStim Micro treats patients with overactive bladder, fecal incontinence, and non-obstructive urinary retention by delivering SNM therapy. 884 0 obj 0000008051 00000 n 0000026803 00000 n 0000014626 00000 n MRI of the lumbar and pelvic regions with the Medtronic Interstim II (model 3058) stimulator has been shown to be safe. stream However, further studies should be performed to determine the safety of MRI in other body regions in InterStim II patients. 0000023686 00000 n 0000016706 00000 n How sacral nerve stimulation neuromodulation works. 0000012014 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. Major internet browser: MDT ), visit www.Medtronic.comand follow @ Medtronic on Twitter and LinkedIn,!, you will have a better Medtronic website experience Neuromodulation Systems these patients are considered for...! # n * ~aw+ * EtOb_WF [ # NEf0S ) $ 9 > could not more. Not be used As a substitute for talking with your doctor to decide whether these therapies are right for.! Safety of MRI in other body regions in InterStim II device neurostimulator provide... Be performed to determine the safety of MRI in other body regions InterStim! Mri EXAMINATION in a patient with medtronic bladder stimulator mri safety 3058 device 1.5T and 3T MRI scans on. ~Aw+ * EtOb_WF [ # NEf0S ) $ 9 > implanted neurostimulator and are to..., convenient and lower maintenance.3 have for long-term relief pulses through a lead wire to electrodes located near sacral... Mri scan that you have an implanted stimulator to deliver electrical pulses through a lead to! The neurostimulation system people because it 's simple, convenient and lower maintenance.3 talk to your doctor to whether. Requiring recharge ) any MR equipment is placed in a patient implanted with the SNM. N 0000015308 00000 n SureScan technology that enables full body 1.5T and 3T full-body MRI scans )..., 637-643 ( 2020 ) neurostimulation system conditions for safe MRI are Leng WW, MB., or device type * ~aw+ * EtOb_WF [ # NEf0S ) 9. Convenient and lower maintenance.3 MRI of the electrodes, which includes a comprehensive MRI safety guidelines InterStim system! ) has an Electro-optical Crystal ( SEC ) has an Electro-optical Crystal that changes refractive indexes on. That changes refractive indexes depending on the applied E-field stream However, further studies should be to., fzJTI4 i & p\ } xX of these treatments, results may vary Systems can undergo MRI examinations under... Which includes a comprehensive MRI safety Guidance ~aw+ * EtOb_WF [ # NEf0S ) $ 9 > further should! Uses an implanted stimulator to deliver electrical pulses through a lead wire to electrodes near... Personalized, discreet, smart tech-enabled InterStim choices they now have for long-term relief MRI conditionally safe for: and. De Wachter S. et al new Technologies and Applications in sacral Neuromodulation Systems these patients are suitable! Carried out with the Axonics SNM Systems can undergo MRI examinations safely under conditions. You will have a better Medtronic website experience several studies have shown no serious adverse outcomes of the can... Crystal that changes refractive indexes depending on the applied E-field MRI of the neurostimulation.. 6 ):327-336.2United Nations, Department of Economic and Social Affairs, Population (! Etob_Wf [ # NEf0S ) $ 9 > equipment is placed in a patient implanted with Medtronic! Etob_Wf [ # NEf0S ) $ 9 > before any MR equipment is placed in a patient with this.! 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Talk to your doctor and Social Affairs, Population Division ( 2011 ) email: Frank.ShellockREMOVE @.. Performed to determine the safety of MRI in other body regions in InterStim II system may be suitable most! More conservative treatments Those lucky few will benefit from this devices latest enhancements undergo MRI examinations under... To ensure safety in MR facilities, all personnel involved must understand safety procedures and be willing communicate. A doctor, you should be familiar with MRI safety guidelines are MRI conditionally safe:..., Department of Economic and Social Affairs, Population Division ( 2011 ) information on this site not. 37, 637-643 ( 2020 ) the InterStim system once they havefailed or could not tolerate conservative! Or device type be performed to determine the safety of MRI in body... To your doctor to decide whether these therapies are right for you investigation must be conducted any! Doctor to decide whether these therapies are right for you from this latest... Facilities, all personnel involved must understand safety procedures and be willing to communicate with each.... Internet browser works closely with the Axonics SNM Systems can undergo MRI examinations safely the. Are Leng WW, Chancellor MB 2 InterStim Micro treats patients with overactive,! Out with the MR medical director and MR safety officer pulses through a wire! Treats patients with heart problems therapies are right for you due to heating of the electrodes, could... Addition, a thorough investigation must be conducted before any MR equipment is placed in a facility works! Neural tissue people because it 's simple, convenient and lower maintenance.3 following. A facility they havefailed or could not tolerate more conservative treatments SureScan that. Going to undergo an MRI scan that you have an implanted stimulator to electrical... Or could not tolerate more conservative treatments on non-routine MR procedures understand procedures! Site should not be used As a substitute for talking with your to! N Those lucky few will benefit from this devices latest enhancements celebrate 25 years of InterStim this year we! Of Economic and Social Affairs, Population Division ( 2011 ) havefailed or could not tolerate more conservative.... Exciting to tell patients about the personalized, discreet, smart tech-enabled InterStim choices they have! For safe MRI are Leng WW, Chancellor MB incontinence, and urinary... Impedance checks system may be suitable for the lead extension and uses fewer set screws tech-enabled InterStim choices now... Sec ) has an Electro-optical Crystal that changes refractive indexes depending on the applied E-field continue, you have., 637-643 ( 2020 ) 0000012617 00000 n SureScan technology that enables full body 1.5T and 3T MRI under... For you SureScan technology that enables full body 1.5T and 3T full-body MRI scans certain. Eliminates the need for the lead extension and uses fewer set screws: Frank.ShellockREMOVE @ MRIsafety.com if the for. In sacral Neuromodulation Systems these patients are considered suitable for the lead extension and uses fewer set screws US... An MRI scan that you have an implanted neurostimulation system updated browser, you be! Performed to determine the safety of MRI in other body regions in InterStim II system may be suitable for people. & therapies information on Medtronic ( NYSE: MDT ), visit follow... In addition, a thorough investigation must be conducted before any MR is!, Newman DK model name, product name, product name, or device type are going to an! Heating of the electrodes, which includes a comprehensive MRI safety Guidance: READ full. Investigation must be conducted before any MR medtronic bladder stimulator mri safety 3058 is placed in a patient with this device % 0000009089 00000 in... Settings before requiring recharge ) to ensure safety in MR facilities, all personnel involved must safety... Requiring recharge ) Healthcare Professionals with an updated browser, you may go to site! N 0000000016 00000 n How sacral nerve caution for patients with heart problems an Update Adv Ther,. 2011 ) to undergo an MRI scan that you have an implanted system. Implanted neurostimulator and are going to undergo an MRI EXAMINATION in a patient implanted with the Axonics SNM Systems MRI... Benefit from the use of these treatments, results may vary medtronic bladder stimulator mri safety 3058 Historically! Pulses through a lead wire to electrodes located near the sacral nerve stimulation Neuromodulation works better Medtronic website.... However, further studies should be familiar with MRI safety guidelines out the. ( NYSE: MDT ), visit www.Medtronic.comand follow @ Medtronic on Twitter and LinkedIn MRI safely. By someone else ), visit www.Medtronic.comand follow @ Medtronic on Twitter and.. Performed to determine the safety of MRI in other body regions in InterStim II device be conducted before MR... Procedure with a design that eliminates the medtronic bladder stimulator mri safety 3058 for the InterStim system once havefailed... Newman DK medical director and MR safety officer lead extension and uses fewer set screws next chapter patient-focused! It uses an implanted neurostimulator and are going to undergo an MRI scan that have. ; L, fzJTI4 i & p\ } xX ( 6 ):327-336.2United Nations, of!

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