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"; 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:"?? If you are a doctor, you should be familiar with MRI safety guidelines. 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: ? 0000018863 00000 n 0000011736 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. 2005;32:1118. 0000016410 00000 n Although many patients may benefit from the use of these treatments, results may vary. 0000008924 00000 n "As we celebrate 25 years of InterStim this year, we're bullish about our next chapter in patient-focused therapy innovation. 9>sa6 ~Ay@Z/l^/!6pLb+{Mk Between NBV133037H and NBV133063H ? 0000004045 00000 n 0000002333 00000 n This unintended stimulation may be uncomfortable (e.g., tingling, shocking, or jolting). Spinal Cord Stimulation, SureScan MRI Version, Medtronic, Inc. 0000011192 00000 n All patients had their parameters recorded; then the IPGs were put to "nominal" status. 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. Persistence and adherence of medications for chronic overactive bladder/urinary incontinence in the California Medicaid Program. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. United States Census Bureau Web site. 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). Considering that the InterStim is a ubiquitous presence in the bladder department, MRI safety is a must. These treatments are prescribed by your doctor. The manufacturers sterilize the products after they are packaged and it lasts so many years. 0000013304 00000 n 0000023883 00000 n endstream endobj 302 0 obj <> endobj 303 0 obj <> endobj 304 0 obj <>stream 0000010106 00000 n 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. ?? These updates also allow for a shorter waiting time between MRI scans. Br J Surg. More information (see more) 0000000016 00000 n hb```b``^d(31 PCAed a2(m``_XA -cMt8{}*[e%A*AN)O0!!6FIIeAaRE#,XMtabX;'1wjg t7eD,zorsaR; ;@xR+ 0000011431 00000 n 0000023719 00000 n "; 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. Those lucky few will benefit from this devices latest enhancements. endstream endobj 306 0 obj <>stream 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]_ Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. 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. y=9iK}xxyC]i2q~6KoNXqUDLJoNCk/_/y@6,6)SuMA<8XUJa!,kW0@'.I*'EluWII)4c1jG2,AAz(e`a`P@9dEb1 B2QPHbD (lT Information on this site should not be used as a substitute for talking with your doctor. Patients Depuy Barrels-Product Line is now a Zimmer Biomet Product, Zimmer Austin-Moore Fenestrated Hip Implants, 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 smart programmer for clinicians, TYRX neuro absorbable antibacterial envelope, Experience urge incontinence or urgency-frequency, Experience urinary retention without an obstruction, Need another option if medication does not provide symptom relief and/or causes unpleasant side effects, Want an alternative to repeated injections, Have not demonstrated an appropriate response to the InterStim/therapy evaluation, Are unable to operate mobile devices (such as the smart programmer for the InterStim system), Are not appropriate candidates for surgery, Experience retention due to obstructions (such as BPH, cancer, or urethral stricture), Experience urge incontinence and/or passive incontinence, Need another option if medication that does not provide symptom relief and/or causes unpleasant side effects, Have issues using mobile devices (such as the smart programmer for the InterStim system). 0000006753 00000 n Update my browser now. This small device will improve patient satisfaction and reduce hospital readmissions. 446 0 obj <>stream Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 1-(800)-723-4636 (Tachy) 1-(800)-505-4636 (Brady) International Technical Centers. ?? {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 Unintended Stimulation MRI may cause unintended stimulation from the implant. Sacral Neuromodulation Systems Please talk to your doctor to decide whether these therapies are right for you. Home 0000009137 00000 n Historically, patients with implantable SNM devices have been contraindicated for MRI. 0000016814 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: 0000018911 00000 n The new labeling also decreases wait time from 60 minutes to 5 minutes for maximum duration scans (30 minutes). Learn the parameters of patient selection for bladder control and bowel control. 0000005846 00000 n 1.5T and 3T head coil MRI scans. 0000013358 00000 n The Interstim II system may be suitable for most people because it's simple, convenient and lower maintenance.3. MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. Regulatory Statements 2. For more information on Medtronic (NYSE:MDT), visit www.Medtronic.comand follow @Medtronic on Twitter and LinkedIn. 0000017618 00000 n Healthcare Professionals The powerful magnetic field of the MR system can also attract these metals, resulting in danger to people inside the room. This therapy is not intended for patients with a urinary blockage. 0000016362 00000 n These therapies are not for everyone. b Power-on-reset (POR) turns OFF stimulation by resetting the amplitude to 0.0 V and all electrodes to OFF. You just clicked a link to go to another website. 0000014238 00000 n m xUMHTQ=gS?X J"!sR$$JQH]"(AAPHm@D1DE6y|#Asw;J 0000008298 00000 n 0000010599 00000 n These instructions do not apply to other implantable products, or other devices, products, or items. 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 @J9z6{,RLZtR!zbh*8 l2azr&_4=OG$Vkwy?5 P&Dg*[@K6WrqFKe]3 Rh)b#0a(Z)#!H Bb*acH@L Q 9 , p043/aeSe3JEANr3>-u8wFXGp. 0000003266 00000 n These instructions do not apply to other implantable products, or other devices, products, or items. 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). 756 0 obj 0000008003 00000 n MRI mode is easy for patients to independently activate or deactivate on the smart programmer. Prevalence and burden of overactive bladder in the United States. 2 InterStim Micro treats patients with overactive bladder, fecal incontinence, and non-obstructive urinary retention by delivering SNM therapy. a)&|@a3ix g].3&^.jFMO5a With an updated browser, you will have a better Medtronic website experience. 2009;137: 512-517.4United States Quick Facts. 884 0 obj 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. 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. 0000005535 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. 0000016706 00000 n 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. That said, you have to ask yourself, are you a patient? 0000010323 00000 n It is possible that some of the products on the other site are not approved in your region or country. Medtronic 3058 Interstim II Neurostimulator for Bladder and Bowel Control. 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. 5Z\&l:|iXeMt+Z5|L| 1v 3tT#`K?FWrS8% 0000015970 00000 n 0000003937 00000 n <> However, it is important to consider the risk posed by your specific MRI scan parameters. 0000011083 00000 n 0000019081 00000 n ", 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. 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. 0000011527 00000 n 0000018245 00000 n 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). Or other devices, products, or items this unintended stimulation may be uncomfortable ( e.g.,,... Not approved in your region or country Technical Centers 2 InterStim Micro treats with... It is possible that some of the products on the smart programmer or deactivate on the smart.... 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