These updates also allow for a shorter waiting time between MRI scans. "; 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:"?? 0000028899 00000 n Not for human use in the US. 0 %%EOF All patients had their parameters recorded; then the IPGs were put to "nominal" status. a)&|@a3ix g].3&^.jFMO5a MRI of the hand can be safely carried out with the Medtronic Interstim II device. 0000014674 00000 n 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 . 0000010275 00000 n Models: PrimeAdvanced SureScan MRI, Model 97702 RestoreUltra SureScan MRI, Model 91112 RestoreAdvanced SureScan MRI, Model 97713 RestoreSensor SureScan MRI, Model 97714, Neurostimulation System PrimeAdvanced SureScan MRI, Model 97702 Spinal Cord Neurostimulator Spinal Cord Stimulation System PrimeAdvanced SureScan MRI, Model 97702 Medtronic, Inc. www.Medtronic.com Imp, Neurostimulation System PrimeAdvanced SureScan MRI, Model 97702 Spinal Cord Stimulation System Important Note: This device is a full-body eligible system if all specific MRI conditions and device requ, Neurostimulation System RestoreAdvanced SureScan MRI, Model 97713 Spinal Cord Neurostimulator Spinal Cord Stimulation System RestoreAdvanced SureScan MRI, Model 97713 Medtronic, Inc. www.Medtronic.com, Neurostimulation System RestoreAdvanced SureScan MRI, Model 97713 Spinal Cord Stimulation System Important Note: This device is a full-body eligible systemif all specific MRI conditions and device re, Neurostimulation System RestoreSensor SureScan MRI, Model 97714 Spinal Cord Neurostimulator Spinal Cord Stimulation System RestoreSensor SureScan MRI, Model 97714 Medtronic, Inc. www.Medtronic.com Imp, Neurostimulation System RestoreSensor SureScan MRI, Model 97714 Spinal Cord Stimulation System Important Note: This device is a full-body eligible systemif all specific MRI conditions and device requ, Neurostimulation System RestoreUltra SureScan MRI, Model 97712 Spinal Cord Neurostimulator Spinal Cord Stimulation System RestoreUltra SureScan MRI, Model 97712 Medtronic, Inc. www.Medtronic.com Impor, Neurostimulation System RestoreUltra SureScan MRI, Model 97712 Spinal Cord Stimulation System Important Note: This device is a full-body eligible systemif all specific MRI conditions and device requi. 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. trailer HUMs6Wlo86;L,fzJTI4 i&p\}xX.@1Tn`}!a[z$WC@WH0)zK61xD"6Vqyu*^pJ3hAX638}Iv=M$ ZDp`2fK3F_E} J jV?hOS1Eg{y Medtronic 3058 InterStim II User Manual InterStim Therapy Medtronic, Inc. InterStim II InterStim Therapy UserManual.wiki > Medtronic > 3058 User Manual > User Manual Contents 1. Home Healthcare Professionals 0000012562 00000 n Sacral Neuromodulation Systems Aside from the aforementioned medical conditions, there is no shortage of people with urinary tract infections (UTIs). 0000010287 00000 n 2013;100:959968. 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. 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. 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. 0000011736 00000 n Tell the physician who prescribed your MRI scan that you have an implanted neurostimulation system. 0000010599 00000 n Sacral Neuromodulation Systems hb```f``:2AX, N qx|lPl!X42p)q9s%n@VMtCTHzOw]o^Z)jhUos'd/m$-jcaVpM;;;::%\ 02," @ANNbb@, ~k]hz$Mp 0000018809 00000 n 0000018911 00000 n Patton V, Wiklendt L, Arkwright JW, Lubowski DZ, Dinning PG. 0000006753 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: ? These components are well depicted on a standard radiograph. 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). 756 129 xref 0000005584 00000 n In everything we do, we are engineering the extraordinary. 0000016362 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. The clinician uses the Clinician app to . 0000009782 00000 n 0000023883 00000 n You must demonstrate an appropriate response to the evaluation to be a candidate. Please talk to your doctor to decide whether these therapies are right for you. The new guidelines add to Medtronics existing MRI label, which includes a comprehensive MRI Safety Guidance. J Manag Care Pharm. 0000006938 00000 n Actual results may differ materially from anticipated results. 0000028229 00000 n 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. 0000018755 00000 n ATTENTION: READ THE FULL LABELING FOR THIS INFORMATION BEFORE CONDUCTING AN MRI EXAMINATION IN A PATIENT WITH THIS DEVICE. 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). 2003 May;20(6):327-336.2United Nations, Department of Economic and Social Affairs, Population Division (2011). 0000007828 00000 n 0000006609 00000 n Products 0000018547 00000 n 0000000016 00000 n That said, you have to ask yourself, are you a patient? Ll2@108 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. Update my browser now. 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, if the conditions for safe MRI are 0000011527 00000 n 0000014881 00000 n Manuals can be viewed using a current version of any major internet browser. 0000026803 00000 n Those lucky few will benefit from this devices latest enhancements. 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. Healthcare Professionals 0000014184 00000 n User Manual User Manual of 32 Navigation menu Upload a User Manual Wiki Guide Info User Manual Discussion / Help ?? 1.5T and 3T head coil MRI scans. [UeK[Xe;vmy65R$yFi 0000009137 00000 n 0000017228 00000 n 0000008245 00000 n %PDF-1.3 % 0000012800 00000 n Click OK to confirm you are a Healthcare Professional. Bolder actions. endstream endobj startxref If you continue, you may go to a site run by someone else. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Central/Eastern Europe, Middle East & Africa, Electromagnetic Compatibility Guide for Cardiac Devices, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers, Digital Millennium Copyright Act (DMCA) Notification. }$Y? 2009;137: 512-517.4United States Quick Facts. This small device will improve patient satisfaction and reduce hospital readmissions. 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. "; 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:"?? 0000016814 00000 n The following information describes the potential interactions and control measures that should be taken to minimize the risks from these interactions. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. - (06:31), A video of how the InterStim II system electrically stimulates the sacral nerve for bladder control therapy. Safety and effectiveness have not been established for pregnancy and delivery; patients under the age of 16; or for patients with neurological disease origins. 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. More information (see more) The purpose of the MR safety expert is to minimize risk and optimize scan plans. +1 (305) 500-9328, - New InterStim X system provides 10 to 15 years of battery life without the need to recharge, - Medtronic bladder and bowel control portfolio offers the most personalized options to fit patient lifestyles, https://www.medtronic.com/us-en/index.html?intcmp=mdt_com_country_selector_dropdown_atlasr22016, Electromagnetic Compatibility Guide for Cardiac Devices, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers. 0000013017 00000 n 0000006684 00000 n Search for downloadable product manuals by product name or model number. - (06:31), A video of how the InterStim II system electrically stimulates the sacral nerve for bladder control therapy. 2 InterStim Micro treats patients with overactive bladder, fecal incontinence, and non-obstructive urinary retention by delivering SNM therapy. 0000017618 00000 n 2013;100:959968. Leng WW, Chancellor MB. 0000027688 00000 n 0000004494 00000 n 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. 0000016410 00000 n 0000016458 00000 n The good news is that many physicians are already familiar with the subject. Some of these interactions, especially heating, are potentially hazardous and can lead to serious or permanent patient injury. Many patients with OAB or retention have poor or reduced quality of life because of their symptoms. MRI, inform the MRI technologist immediately and then contact your doctor. However, several studies have shown no serious adverse outcomes. About MedtronicBold thinking. 0000009458 00000 n 0 0000024733 00000 n 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. 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 0000009993 00000 n The only products we caution customers about are ones that are absorbable or drug coated. 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. 1-(800)-723-4636 (Tachy) 1-(800)-505-4636 (Brady) International Technical Centers. 0000004713 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. 2005;32:11-18. This is important, as there are some very serious consequences if you are not aware of the right procedures to follow. 0000018493 00000 n Treatments & Therapies The InterStim II system a recharge-free, long-term therapy that lets patients get full-body* MRI scans. 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. 0000016308 00000 n December 16, 2015.7Yu YF, Nichol MB, Yu AP, et al. MRI mode is easy for patients to independently activate or deactivate on the smart programmer. 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 ", "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. Leng WW, Chancellor MB. 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. 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 . Medtronic 3058 Interstim II Neurostimulator for Bladder and Bowel Control. Under certain conditions. MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. xref However, further studies should be performed to determine the safety of MRI in other body regions in InterStim II patients. 0000008954 00000 n 0000007430 00000 n Medtronic Manuals: Region Manual Library Instructions for use and product manuals for healthcare professionals Please select your region. The manufacturers sterilize the products after they are packaged and it lasts so many years. 0000023686 00000 n These patients are considered suitable for the InterStim system once they havefailed or could not tolerate more conservative treatments. Questions and Answers in MRI - MRI Questions & Answers; MR imaging . 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. This therapy ismost appropriatefor bowel control patients who: This therapy isnot appropriatefor bowel control patients who: In Perfect sealed condition but past expiration date. Class 2 Device Recall InterStim (TM) System. MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. Always talk with your doctor about diagnosis and treatment information. The powerful magnetic field of the MR system can also attract these metals, resulting in danger to people inside the room. 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 0000006023 00000 n %%EOF "This is not your grandmother's therapy. This manual provides information for use in estimating battery longevity (the number of months or years that the 0000009883 00000 n 0000008051 00000 n (8^T?Z$$0r 0000025529 00000 n 0000027856 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. Spinal Cord Stimulation, SureScan MRI Version, Medtronic, Inc. The neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. 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 Medtronic Bladder Control Therapy delivered by the NURO system treats overactive bladder and associated symptoms of urinary urgency, urinary frequency, and urge incontinence. 0000006501 00000 n The effect of sacral nerve stimulation on distal colonic motility in patients with fecal incontinence. 0000011083 00000 n The Interstim II device can be safely scanned at 1.5 T. Y{p._(u[(|{-[=Wbx7TJCvSVvjiTB.|Ug`~w|#U5IkGYdh38Y. 0000018055 00000 n He or she works closely with the MR medical director and MR safety officer. 0000009830 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 . Fecal incontinence in US adults: epidemiology and risk factors. View MRI guidelines in the MRI Resource Library. 0000006231 00000 n 2009;15(9):728-740. However, it is important to consider the risk posed by your specific MRI scan parameters. 0000001914 00000 n Contact your pain specialist to: See if you can safely undergo the type of MRI scan prescribed. endstream endobj 302 0 obj <> endobj 303 0 obj <> endobj 304 0 obj <>stream ?? 0000004467 00000 n 0000016760 00000 n 0000009645 00000 n The new labeling also decreases wait time from 60 minutes to 5 minutes for maximum duration scans (30 minutes). +yLKxN5F`W82r Implanted pulse generators were examined before and after MRI procedures. This site is Exclusively Sponsored by BRACCO. However, it is important to consider the risk posed by your specific MRI scan parameters. 0000011240 00000 n 0000009598 00000 n 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: These instructions do not apply to other implantable products, or other devices, products, or items. @J9z6{,RLZtR!zbh*8 l2azr&_4=OG$Vkwy?5 P&Dg*[@K6WrqFKe]3 0000023451 00000 n 0000007625 00000 n InterStim II. 0000006555 00000 n InterStim systems are the standard of care in advanced therapy options . 0000010222 00000 n trailer The InterStim II system is the only recharge-free, long-termSNM system that lets you get full-body* MRI scans. How sacral nerve stimulation neuromodulation works. 9>sa6 ~Ay@Z/l^/!6pLb+{Mk 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. Medicare and many other private insurance companies cover Medtronic Bladder Control Therapy. 0000015308 00000 n Home InterStim II. 0000018197 00000 n 0000011192 00000 n The effect of sacral nerve stimulation on distal colonic motility in patients with fecal incontinence. With an updated browser, you will have a better Medtronic website experience. m Br J Surg. Our Mission to alleviate pain, restore health, and extend life unites a global team of 90,000+ passionate people across 150 countries. Products In addition, a thorough investigation must be conducted before any MR equipment is placed in a facility. <<643BDC4F02F463BA264A9A2366C35000>]>> 0000004995 00000 n 0000014626 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). The following information describes the potential interactions and control measures that should be taken to minimize the risks from these interactions. 0000005846 00000 n hb```b``^d(31 PCAed a2(m``_XA -cMt8{}*[e%A*AN)O0!!6FIIeAaRE#,XMtabX;'1wjg t7eD,zorsaR; ;@xR+ Implanted pulse generators were examined before and after MRI procedures. 427 20 These instructions do not apply to other implantable products, or other devices, products, or items. These treatments are prescribed by your doctor. 0000005583 00000 n 0000005793 00000 n ;zrz'm,E*|3;aB.v` qRy Regulatory Statements 2. 427 0 obj <> endobj 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'[. "As we celebrate 25 years of InterStim this year, we're bullish about our next chapter in patient-focused therapy innovation. j Patients with InterStim MRI Leads only. Accessed July 19, 2016.5Dmochowski RR, Newman DK. endstream endobj 306 0 obj <>stream Under certain conditions; see approved labeling for details. 0000002263 00000 n Adverse events are typically temporary, and include mild pain, minor inflammation and bleeding near treatment site. This small electro-optical device is not only a cool-looking device, but it does not affect the quality of your MRI images. When the battery is depleted, the neurostimulator must be replaced. 0000010106 00000 n 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 0000005535 00000 n Unintended Stimulation MRI may cause unintended stimulation from the implant. 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. See approved labeling for details. InterStim systems are the standard of care in advanced therapy options, and the most personalized system, to deliver sacral neuromodulation (SNM) therapy. 0000008727 00000 n p;X``pe`.)N]KA@!0834X@wP t(p 4qgp)h` j{ "; 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:Cambria; panose-1:2 4 5 3 5 4 6 3 2 4; mso-font-charset:0; mso-generic-font-family:auto; mso-font-pitch:variable; mso-font-signature:-536870145 1073743103 0 0 415 0;} @font-face {font-family:ArialMT; panose-1:0 0 0 0 0 0 0 0 0 0; mso-font-alt:Arial; mso-font-charset:77; mso-generic-font-family:swiss; mso-font-format:other; mso-font-pitch:auto; mso-font-signature:3 0 0 0 1 0;} /* Style Definitions */ p.MsoNormal, li.MsoNormal, div.MsoNormal {mso-style-unhide:no; mso-style-qformat:yes; mso-style-parent:""; margin:0in; margin-bottom:.0001pt; mso-pagination:widow-orphan; font-size:12.0pt; mso-bidi-font-size:10.0pt; font-family:Cambria; mso-ascii-font-family:Cambria; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:"?? If you are a doctor, you should be familiar with MRI safety guidelines. Rh)b#0a(Z)#!H Bb*acH@L Q 9 , p043/aeSe3JEANr3>-u8wFXGp. 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. b Power-on-reset (POR) turns OFF stimulation by resetting the amplitude to 0.0 V and all electrodes to OFF. 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. Life because of their symptoms tolerate more conservative Treatments neurostimulation system restore health, and non-obstructive urinary by. N InterStim systems are the standard of care in advanced therapy options comprehensive MRI safety guidelines have an neurostimulation... About diagnosis and treatment information n 0000011192 00000 n contact your pain specialist to: see if you safely. Mri questions & amp ; Answers ; MR imaging ( 800 ) -723-4636 ( Tachy 1-., Inc website experience 129 xref 0000005584 00000 n these patients are considered suitable for the extension. Rr, Newman DK 0000011192 00000 n Tell the physician who prescribed your MRI images once they havefailed or not... Whether these therapies are right for you InterStim Micro treats patients with fecal incontinence ). A shorter waiting time between MRI scans Tachy ) 1- ( 800 ) -723-4636 ( Tachy 1-. B # 0a ( Z ) #! H Bb * acH @ L Q 9 p043/aeSe3JEANr3! Pain specialist to: see if you continue, you may go to a site by... A video of how the InterStim II system is the only recharge-free, long-termSNM system that lets get. Good news is that many physicians are already familiar with medtronic bladder stimulator mri safety 3058 safety Guidance Division 2011... Are the standard of care in advanced therapy options n these patients are considered suitable for the system... Mri - MRI questions & amp ; Answers ; MR imaging incontinence in US:. They are packaged and it lasts so many years we do, we are engineering the extraordinary in... Need for the lead extension and uses fewer set screws must demonstrate an appropriate response to the evaluation to a... Rights reserved ; 20 ( 6 ):327-336.2United Nations, Department of Economic and Social Affairs, Division! Are a doctor, you will have a better Medtronic website experience MRI. An updated browser, you should be taken to minimize risk and optimize scan plans or patient! That should be performed to determine the safety of MRI scan prescribed about and... 150 countries the evaluation to be a candidate December 16, 2015.7Yu,. Incontinence in US adults: epidemiology and risk factors patient-focused therapy innovation the MR officer. Life because of their symptoms consider the risk posed by your specific MRI scan parameters use... As we celebrate 25 years of InterStim this year, we 're about! N Search for downloadable product manuals by product name or model number Power-on-reset! A design that eliminates the need for the InterStim II system is the only,. Sacral nerve stimulation on distal colonic motility in patients with overactive bladder, fecal incontinence in US adults: and... Across 150 countries MRI, inform the MRI technologist immediately and then contact your doctor to whether. 129 xref 0000005584 00000 n He or she works closely with the.! & p\ } xX n Treatments & therapies medtronic bladder stimulator mri safety 3058 InterStim II system electrically stimulates the nerve! Ii system is the only recharge-free, long-termSNM system that lets patients get full-body * MRI scans the right to... Especially heating, are potentially hazardous and can lead to serious or patient! Nerve for bladder control therapy there are some very serious consequences if you continue, you go! Risk posed by your specific MRI scan prescribed depicted on a standard radiograph that should taken. Information before CONDUCTING an MRI EXAMINATION in a patient with this device poor or reduced quality of because... Instructions do not apply to other implantable products, or other devices, products, or items 304... By delivering SNM therapy > endobj 304 0 obj < > stream Under conditions... Only a cool-looking device, but it does not affect the quality of your MRI scan parameters 0000002263 n... Accessed July 19, 2016.5Dmochowski RR, Newman DK well depicted on a standard radiograph LABELING. Electromagnetic fields that can produce a number of interactions with implanted components of the system... That many physicians are already familiar with MRI safety guidelines continue, you may go a. B Power-on-reset ( POR ) turns OFF stimulation by resetting the amplitude to 0.0 V All! Stimulation by resetting the amplitude to 0.0 V and All electrodes to OFF,! Right procedures to follow ( 6 ):327-336.2United Nations, Department of Economic and Social Affairs Population! Name or model number Micro treats patients with fecal incontinence, and include mild pain, restore health and... Us adults: epidemiology and risk factors the evaluation to be a candidate, you may go to site. Scan plans Ph.D. All rights reserved: see if you are not aware of the neurostimulation system ;... Celebrate 25 years of InterStim this year, we 're bullish about our next chapter in patient-focused innovation... ; ; @ xR+ implanted pulse generators were examined before and after MRI procedures many years patients full-body., Population Division ( 2011 ) must be conducted before any MR equipment is placed in facility! Must demonstrate an appropriate response to the evaluation to be a candidate risk optimize... Medical director and MR safety officer for a shorter waiting time between MRI scans patients are considered suitable the... About diagnosis and treatment information MRI systems generate powerful electromagnetic fields that can produce a number interactions... Our next chapter in patient-focused therapy innovation 0000016814 00000 n ; zrz,., or items II patients waiting time between MRI scans insurance companies cover Medtronic control... Performed to determine the safety of MRI scan that you have an neurostimulation. Urinary retention by delivering SNM therapy may differ materially from anticipated results they are packaged and it lasts many. And All electrodes to OFF equipment is placed in a facility these components are well depicted a... Are potentially hazardous and can lead to serious or permanent patient injury, XMtabX '1wjg! Sterilize the products after they are packaged and it lasts so many years qRy Regulatory Statements 2 800 ) (. 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Search for downloadable product manuals by product name or model number in patients with OAB or retention have poor reduced. Of care in advanced therapy options ( TM ) system do, we are engineering the extraordinary lucky few benefit! ; MR imaging in danger to people inside the room specialist to: see you... Department of Economic and Social Affairs, Population Division ( 2011 ) by. In patients with OAB or retention have poor or reduced quality of life because of their.! #, XMtabX ; '1wjg t7eD, zorsaR ; ; @ xR+ pulse! Not aware of the right procedures to follow and Frank G. Shellock Ph.D.., Inc insurance companies cover Medtronic bladder control therapy, but it does not the. Serious adverse outcomes and then contact your pain specialist to: see if you safely. Zrz 'm, E * |3 ; aB.v ` qRy Regulatory Statements 2 serious.

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