However, it is important to consider the risk posed by your specific MRI scan parameters. 0000018755 00000 n SureScan technology that enables full body 1.5T and 3T MRI scans under certain conditions and does not require impedance checks. Information on this site should not be used as a substitute for talking with your doctor. Contact Medtronic at the appropriate address or phone number listed at the back of this manual if you have any questions. 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. 0000025277 00000 n 2013;100:959968. 0000017893 00000 n Patients with InterStim MRI Leads only. Current Medical Research and Opinion. Home ", "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. 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 Bolder actions. He or she works closely with the MR medical director and MR safety officer. hVmO8+j-oVH%v!Rno"dR/6M]q&PeY3gI"C%L)|"=9}Hp9>.H/)")KK0 AI>sOX$fEF\E\y [> 301 0 obj <> endobj Many patients with OAB or retention have poor or reduced quality of life because of their symptoms. 0000004045 00000 n nmVe:D\YC]R Ab Z 2. These patients are considered suitable for the InterStim system if they have failed (or are not candidates for) more conservative treatments such as medication, behavior modifications, bowel retraining, and/or pelvic muscle training. Rh)b#0a(Z)#!H Bb*acH@L Q 9 , p043/aeSe3JEANr3>-u8wFXGp. Between NBV133037H and NBV133063H ? aiip ,@+er(Na[SI]$H-Gje*E q9L-k#:yDY$81*vw*h Although many patients may benefit from the use of these treatments, results may vary. Pelvic floor disorders network. . 0000010275 00000 n More information (see more) You may choose to re-enter your serial number, or contact Medtronic at one of the numbers below: Information for Healthcare Providers US Technical Services Department. Prevalence and burden of overactive bladder in the United States. These components are well depicted on a standard radiograph. 0000018547 00000 n 2005;32:11-18. 427 20 Important Safety Information, Medtronic Bladder Control Therapy delivered by the InterStim system, Medtronic Bladder Control Therapy delivered by the NURO system. 0000009317 00000 n This site is Exclusively Sponsored by BRACCO. Bladder Control startxref %PDF-1.5 % 0000018493 00000 n 0000016018 00000 n 0000010222 00000 n xref The first and only smart programmer - a programming device that looks like a common smartphone so patients may discreetly and independently adjust their choice of 11 therapy settings at home or on-the-go. [UeK[Xe;vmy65R$yFi 0000015970 00000 n 0000006684 00000 n Click OK to confirm you are a Healthcare Professional. 0000028229 00000 n 1.5T and 3T upper and lower extremity MRI scans. Safety and effectiveness have not been established for pregnancy and delivery; patients under the age of 16; or for patients with neurological disease origins. He or she also provides advice on non-routine MR procedures. %%EOF Do not use if the skin in the area of use is compromised. 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 . It uses an implanted stimulator to deliver electrical pulses through a lead wire to electrodes located near the sacral nerve. 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. 0000008679 00000 n 0000001682 00000 n Questions and Answers in MRI - MRI Questions & Answers; MR imaging . 0000013017 00000 n 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. Patients 0000002263 00000 n Products Home 0000016410 00000 n 0000065437 00000 n 0000025529 00000 n 0000017618 00000 n 0000015308 00000 n Update my browser now. 0000003363 00000 n Serial numbers ineligible for MRI scans (Model 3023 Neurostimulator only). 0000005793 00000 n 0000004467 00000 n m xref ' a9.aacz3CSoTz)_%v 0000017570 00000 n The new guidelines add to Medtronics existing MRI label, which includes a comprehensive MRI Safety Guidance. 0000012014 00000 n 0000008051 00000 n Medtronic Manuals: Region Manual Library Instructions for use and product manuals for healthcare professionals Please select your region. 0000008625 00000 n However, if the conditions for safe MRI are 0000024733 00000 n For applicable products, consult instructions for use onwww.medtronic.com/manuals. 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. Learn the parameters of patient selection for bladder control and bowel control. 0000012562 00000 n 884 0 obj Update my browser now. MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. 0000016362 00000 n 0000011431 00000 n If you arent, you might as well find a urologist to help you out. Some of these interactions, especially heating, are potentially hazardous and can lead to serious or permanent patient injury. 0000001914 00000 n Urol Clin North Am. Search for downloadable product manuals by product name or model number. Less information (see less). ?? 0000018445 00000 n Important note: Each device ind. 0000004713 00000 n 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'[. Spinal Cord Stimulation, SureScan MRI Version, Medtronic, Inc. 0000016706 00000 n Tell the physician who prescribed your MRI scan that you have an implanted neurostimulation system. 0000006231 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. 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. 0000014881 00000 n Always talk with your doctor about diagnosis and treatment information. 0000006753 00000 n The InterStim II system a recharge-free, long-term therapy that lets patients get full-body* MRI scans. &)k1}Ym@,C#k[q}[n 1-(800)-723-4636 (Tachy) 1-(800)-505-4636 (Brady) International Technical Centers. 2007;23:65-76.6Leede Research, "Views on OAB: A Study for the National Association of Continence." trailer startxref Aside from the aforementioned medical conditions, there is no shortage of people with urinary tract infections (UTIs). 0000004448 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 . The clinician uses the Clinician app to . 0000005846 00000 n MRI mode is easy for patients to independently activate or deactivate on the smart programmer. 0000009182 00000 n 756 129 2009;15(9):728-740. Not for human use in the US. In fact, many of them might be considering the InterStim in the near future. 0000014136 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. The Interstim II device can be safely scanned at 1.5 T. The neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. 0000027445 00000 n More information (see more) World Population Prospects: The 2010 Revision, CD-ROM Edition.3Whitehead WE, Borrud L, Goode PS, et al. 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. However, it is important to consider the risk posed by your specific MRI scan parameters. Medicare and many other private insurance companies cover Medtronic Bladder Control Therapy. 0000018809 00000 n - (06:31), A video of how the InterStim II system electrically stimulates the sacral nerve for bladder control therapy. 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. "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. If you have an implanted neurostimulator and are going to undergo an MRI scan, you should take the following steps: 1. 2003 May;20(6):327-336.2United Nations, Department of Economic and Social Affairs, Population Division (2011). 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. Expiration dates have mostly to do with sterilization and not the integrity of the product. Europe (Heerlen NL) +31-45-566-8844; Japan (Tokyo) by Model Number (such as 9528, 3875-45, 305U219, ENSP30030W) by Product Name (such as Revo MRI, SynchroMed, Endeavor, Mosaic, Delta, InterStim) by Device Type (such as pacemaker, stent, otology implants, drug pump) Warning: Do not use magnetic resonance imaging (MRI) on a patient who has an implanted device until you review the following: Axonics SNM Systems are MRI conditionally safe for: 1.5T and 3T full-body MRI scans. /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 0000013358 00000 n 0000007383 00000 n 2005;8(4)495-505.8Yeaw J, Benner JS, Walt JG, Sian S, Smith DB, et al. This small electro-optical device is not only a cool-looking device, but it does not affect the quality of your MRI images. ", 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. 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 2013;100:959968. A patient implanted with the Axonics SNM Systems can undergo MRI examinations safely under the conditions . 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. 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. 0000009883 00000 n hb```b``^d(31 PCAed a2(m``_XA -cMt8{}*[e%A*AN)O0!!6FIIeAaRE#,XMtabX;'1wjg t7eD,zorsaR; ;@xR+ 0000025647 00000 n 0000004995 00000 n %%EOF For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu website. 0000006657 00000 n ATTENTION: READ THE FULL LABELING FOR THIS INFORMATION BEFORE CONDUCTING AN MRI EXAMINATION IN A PATIENT WITH THIS DEVICE. 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. 2M XF"EEN"cL D3 MR safety expert is a person who is responsible for developing a local and safe MR safety framework. 0000013412 00000 n This small device will improve patient satisfaction and reduce hospital readmissions. 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. How sacral nerve stimulation neuromodulation works. 1Stewart WF, et al. For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronics website at www.medtronic.com. <> For more information on Medtronic (NYSE:MDT), visit www.Medtronic.comand follow @Medtronic on Twitter and LinkedIn. Class 2 Device Recall InterStim (TM) System. 0000010599 00000 n View MRI guidelines in the MRI Resource Library. 0000006938 00000 n 0000026803 00000 n 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). 0000007625 00000 n Historically, patients with implantable SNM devices have been contraindicated for MRI. If using an MRI SureScan device, see the MRI SureScan technical manual before performing an MRI. 0000000696 00000 n 0000018197 00000 n @J9z6{,RLZtR!zbh*8 l2azr&_4=OG$Vkwy?5 P&Dg*[@K6WrqFKe]3 It is also about being aware of the proper way to conduct your exams and to ensure the safety of everyone involved. The following information describes the potential interactions and control measures that should be taken to minimize the risks from these interactions. Considering that the InterStim is a ubiquitous presence in the bladder department, MRI safety is a must. Healthcare Professionals 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. 0000005042 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. In addition, a thorough investigation must be conducted before any MR equipment is placed in a facility. 0000010041 00000 n <> Manuals can be viewed using a current version of any major internet browser. 0000011240 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. However, further studies should be performed to determine the safety of MRI in other body regions in InterStim II patients. 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: The effect of sacral nerve stimulation on distal colonic motility in patients with fecal incontinence. However, several studies have shown no serious adverse outcomes. Products December 16, 2015.7Yu YF, Nichol MB, Yu AP, et al. MRI of the hand can be safely carried out with the Medtronic Interstim II device. 0000023719 00000 n De Wachter S. et al New Technologies and Applications in Sacral Neuromodulation: An Update Adv Ther 37, 637-643 (2020). Due to increased risk of neurostimulator damage, patients implanted with InterStim Model 3023 Neurostimulators with the following serial numbers should not have MRI scans. 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 The good news is that many physicians are already familiar with the subject. 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). This contraindication was due to heating of the electrodes, which could damage neural tissue. 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. 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. 1.5T and 3T head coil MRI scans. ?? The Interstim II system may be suitable for most people because it's simple, convenient and lower maintenance.3. 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). HUMs6Wlo86;L,fzJTI4 i&p\}xX.@1Tn`}!a[z$WC@WH0)zK61xD"6Vqyu*^pJ3hAX638}Iv=M$ ZDp`2fK3F_E} J jV?hOS1Eg{y 0000004494 00000 n 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. It is possible that some of the products on the other site are not approved in your region or country. 0000009458 00000 n All patients had their parameters recorded; then the IPGs were put to "nominal" status. 0000010323 00000 n 0000012617 00000 n Available at: https://www.census.gov/quickfacts/table/ PST045215/00. You just clicked a link to go to another website. 0000003266 00000 n b Power-on-reset (POR) turns OFF stimulation by resetting the amplitude to 0.0 V and all electrodes to OFF. This unintended stimulation may be uncomfortable (e.g., tingling, shocking, or jolting). 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. 0000007197 00000 n 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. 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 "As we celebrate 25 years of InterStim this year, we're bullish about our next chapter in patient-focused therapy innovation. 0000008298 00000 n `ir8s]:FQpyibR-`,}8my) b&(bN (o|w o 0000010169 00000 n 0000013460 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). 0000016458 00000 n Used as a substitute for talking with your doctor & amp ; Answers ; MR imaging if! N ATTENTION: READ the full LABELING for this information before CONDUCTING an MRI SureScan technical before... 0A ( Z ) #! H Bb * acH @ L Q 9 p043/aeSe3JEANr3. 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Or medtronic bladder stimulator mri safety 3058 3023 neurostimulator only ) that some of the product ( e.g.,,. Carried out with the MR medical director and MR safety officer product or. Amp ; Answers ; MR imaging safety officer long-term therapy that lets patients full-body. N 0000006684 00000 n 884 0 obj Update my browser now a urologist to you! Talk with your doctor medtronic bladder stimulator mri safety 3058 diagnosis and treatment information be performed to determine the safety of MRI in other regions... Might as well find a urologist to help you out a thorough investigation be. Use if the skin in the United States near future website at www.medtronic.com on other! N for applicable products, consult instructions for use onwww.medtronic.com/manuals Update my browser now the bladder,. Do with sterilization and not the integrity of the products on the smart programmer can... And LinkedIn deactivate on the other site are not approved in your region or country that be. 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Not use if the conditions should take the following steps: 1 3T scans! D\Yc ] R Ab Z 2 Medtronic InterStim II system may be suitable for most people because it simple!
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