9>sa6 ~Ay@Z/l^/!6pLb+{Mk Due to increased risk of neurostimulator damage, patients implanted with InterStim Model 3023 Neurostimulators with the following serial numbers should not have MRI scans. Medtronic Bladder Control Therapy delivered by the NURO system treats overactive bladder and associated symptoms of urinary urgency, urinary frequency, and urge incontinence. Contact Medtronic at the appropriate address or phone number listed at the back of this manual if you have any questions. Adverse events are typically temporary, and include mild pain, minor inflammation and bleeding near treatment site. Information on this site should not be used as a substitute for talking with your doctor. How sacral nerve stimulation neuromodulation works. endstream endobj 428 0 obj <. More information (see more) Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 0000010275 00000 n 0000017228 00000 n 0000008350 00000 n De Wachter S. et al New Technologies and Applications in Sacral Neuromodulation: An Update Adv Ther 37, 637-643 (2020). 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. 0000017893 00000 n Tell the physician who prescribed your MRI scan that you have an implanted neurostimulation system. neurostimulator will provide stimulation at programmed settings before requiring recharge). The clinician uses the Clinician app to . Urol Clin North Am. 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: - 1.5-Tesla (T) horizontal closed bore - Maximum spatial gradient of 19 T/m (1900 gauss/cm) - RF transmit/receive head coil only (no RF transmit body coil) - Gradient slew rate limited to 200 T/m/s - Normal operating mode (Scanning frequency of approximately 64 MHz only) - If possible, do not sedate the patient - Model 3058 and eligible Model 3023 Neurostimulators: Turn the neurostimulator off - Eligible Model 3023 Neurostimulators only: Disable the magnet switch Scanning under different conditions may result in severe patient injury or device malfunction. 0000005583 00000 n Rh)b#0a(Z)#!H Bb*acH@L Q 9 , p043/aeSe3JEANr3>-u8wFXGp. Products 0000016308 00000 n This includes a new B1+rms technology for 1.5Tesla scans, and an updated label that adds more flexibility to clinicians practices. 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). MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. The new guidelines add to Medtronics existing MRI label, which includes a comprehensive MRI Safety Guidance. Actual results may differ materially from anticipated results. 0000008625 00000 n Y{p._(u[(|{-[=Wbx7TJCvSVvjiTB.|Ug`~w|#U5IkGYdh38Y. 0000007625 00000 n If using an MRI SureScan device, see the MRI SureScan technical manual before performing an MRI. 0000025647 00000 n He or she also provides advice on non-routine MR procedures. 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 . Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Healthcare Professionals The InterStim II system is the only recharge-free, long-termSNM system that lets you get full-body* MRI scans. Contact Medtronic at the appropriate address or phone number listed at the back of this manual if you have any questions. 2009;15(9):728-740. (8^T?Z$$0r User Manual User Manual of 32 Navigation menu Upload a User Manual Wiki Guide Info User Manual Discussion / Help Regulatory Statements 2. hbbd```b``^"w L 5(09"z@d)6yd&` e:S&F=`iE 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 0000023020 00000 n 0000011527 00000 n 0000003937 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). Many patients with OAB or retention have poor or reduced quality of life because of their symptoms. Some of these interactions, especially heating, are potentially hazardous and can lead to serious or permanent patient injury. InterStim II. Both devices are used in the treatment of overactive bladder (OAB), chronic fecal incontinence (FI), and non-obstructive urinary retention. 0000008051 00000 n 756 129 0000024733 00000 n Medtronic Manuals: Region Manual Library Instructions for use and product manuals for healthcare professionals Please select your region. This therapy is not intended for patients with a urinary blockage. If this patient is implanted with an InterStim II Model 3058 Neurostimulator or an eligible serial number of an InterStim Model 3023 Neurostimulator (when implanted as a system including a neurostimulator, lead, and, extension as applicable), MRI examinations of the head only may be safely performed, - Maximum spatial gradient of 19 T/m (1900 gauss/cm), - RF transmit/receive head coil only (no RF transmit body coil), - Gradient slew rate limited to 200 T/m/s, - Normal operating mode (Scanning frequency of approximately 64 MHz only), - Model 3058 and eligible Model 3023 Neurostimulators: Turn the neurostimulator, - Eligible Model 3023 Neurostimulators only: Disable the magnet switch, Scanning under different conditions may result in severe patient injury or device. 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 . 0000009912 00000 n Search by model name, product name, or device type. The Interstim II device can be safely scanned at 1.5 T. The latest InterStim is a small, discreet device, making it a safe option for many. 1.5T and 3T head coil MRI scans. 0000026803 00000 n trailer When the battery is depleted, the neurostimulator must be replaced. 0000012014 00000 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. 0000011736 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. Br J Surg. 0000011192 00000 n <> 0000010503 00000 n World J Urol. However, it is important to consider the risk posed by your specific MRI scan parameters. 0000027688 00000 n You must demonstrate an appropriate response to the evaluation to be a candidate. Medtronic Interstim 3058 MRI Safety MRI of the hand MRI of the hand can be safely carried out with the Medtronic Interstim II device. endstream endobj 306 0 obj <>stream This is important, as there are some very serious consequences if you are not aware of the right procedures to follow. 0000006184 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. 0000004448 00000 n Value in Health. Home In August 2020, the FDA approved the InterStim Micro neurostimulator and InterStim SureScan MRI leads for the treatment of patients with bladder and bowl control conditions. Between NBV133037H and NBV133063H ? 0000006609 00000 n @J9z6{,RLZtR!zbh*8 l2azr&_4=OG$Vkwy?5 P&Dg*[@K6WrqFKe]3 0000018959 00000 n This therapy ismost appropriatefor bowel control patients who: This therapy isnot appropriatefor bowel control patients who: In Perfect sealed condition but past expiration date. 0000019081 00000 n Unintended Stimulation MRI may cause unintended stimulation from the implant. 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). 0000015970 00000 n These components are well depicted on a standard radiograph. 0000009883 00000 n In order to ensure safety in MR facilities, all personnel involved must understand safety procedures and be willing to communicate with each other. 0000003363 00000 n <> It uses an implanted stimulator to deliver electrical pulses through a lead wire to electrodes located near the sacral nerve. The effect of sacral nerve stimulation on distal colonic motility in patients with fecal incontinence. 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. J Manag Care Pharm. 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. ?? 0000009137 00000 n 427 0 obj <> endobj The InterStim II Model 3058 Neurostimulator is not rechargeable. Implanted pulse generators were examined before and after MRI procedures. View MRI guidelines in the MRI Resource Library. Patients with InterStim SureScan MRI leads only. 0000025277 00000 n 2005;32:11-18. 0000124808 00000 n InterStim systems are the standard of care in advanced therapy options . 0000008727 00000 n 0000004467 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. Several precautions should be taken, including selecting the appropriate coil and positioning the patient outside the MRI scanner room. 0000014402 00000 n p;X``pe`.)N]KA@!0834X@wP t(p 4qgp)h` j{ %%EOF The Axonics Sacral Neuromodulation (SNM) System is a sacral nerve stimulation (SNS) system that is intended to treat urinary retention and the symptoms of overactive bladder. ?? 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. For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronics website at www.medtronic.com. 0000018445 00000 n <<643BDC4F02F463BA264A9A2366C35000>]>> 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. 0000005042 00000 n 0000005225 00000 n aiip ,@+er(Na[SI]$H-Gje*E q9L-k#:yDY$81*vw*h "; 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:"?? These instructions do not apply to other implantable products, or other devices, products, or items. 0000009317 00000 n If you continue, you may go to a site run by someone else. 0000004372 00000 n 0000010287 00000 n Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. endstream endobj 307 0 obj <>stream 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 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 . Prevalence and burden of overactive bladder in the United States. Important Safety Information, Medtronic Bladder Control Therapy delivered by the InterStim system, Medtronic Bladder Control Therapy delivered by the NURO system. There have been few studies evaluating the risk of MRI in patients with this implant. 0000023883 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. 0000010323 00000 n <<8176020B0CB4AE4A9F0BF88D5F2A90DE>]/Prev 621018>> 0000006938 00000 n hb```f``:2AX, N qx|lPl!X42p)q9s%n@VMtCTHzOw]o^Z)jhUos'd/m$-jcaVpM;;;::%\ 02," @ANNbb@, ~k]hz$Mp 0000007795 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. 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. That said, you have to ask yourself, are you a patient? 0000016458 00000 n 0000008924 00000 n 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. 2. Pelvic floor disorders network. Fecal incontinence in US adults: epidemiology and risk factors. December 16, 2015.7Yu YF, Nichol MB, Yu AP, et al. For best results, use Adobe Acrobat Reader with the browser. endstream endobj startxref In addition, a thorough investigation must be conducted before any MR equipment is placed in a facility. 0000012610 00000 n Copyright 2022 / interstim.net - All rights reserved! MRI of the lumbar and pelvic regions with the Medtronic Interstim II (model 3058) stimulator has been shown to be safe. 0000018493 00000 n 0000011431 00000 n The good news is that many physicians are already familiar with the subject. 2009;137: 512-517.4United States Quick Facts. 0000013017 00000 n Search for downloadable product manuals by product name or model number. . 0000002263 00000 n 0 HUMs6Wlo86;L,fzJTI4 i&p\}xX.@1Tn`}!a[z$WC@WH0)zK61xD"6Vqyu*^pJ3hAX638}Iv=M$ ZDp`2fK3F_E} J jV?hOS1Eg{y ;zrz'm,E*|3;aB.v` qRy Serial numbers ineligible for MRI scans (Model 3023 Neurostimulator only). 0000012800 00000 n Medtronic plc, headquartered in Dublin, Ireland, is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. I~!#N*~aw+*EtOb_WF[#NEf0S)$9>! It is possible that some of the products on the other site are not approved in your region or country. 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: You just clicked a link to go to another website. &)k1}Ym@,C#k[q}[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 . 0000023451 00000 n 0000016814 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 World Population Prospects: The 2010 Revision, CD-ROM Edition.3Whitehead WE, Borrud L, Goode PS, et al. 0000011240 00000 n However, further studies should be performed to determine the safety of MRI in other body regions in InterStim II patients. "; 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:"?? 0000005392 00000 n 301 0 obj <> endobj Questions and Answers in MRI - MRI Questions & Answers; MR imaging . 0000000696 00000 n Between NBV628045S and NBV628263S MR healthcare professionals are advised to contact the respective manufacturer in order to obtain the latest safety information to ensure patient safety relative to the use of an MR procedure. 0000016410 00000 n b Power-on-reset (POR) turns OFF stimulation by resetting the amplitude to 0.0 V and all electrodes to OFF. 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. xUMHTQ=gS?X J"!sR$$JQH]"(AAPHm@D1DE6y|#Asw;J 0000027856 00000 n Save my name, email, and website in this browser for the next time I comment. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu website. If you have an implanted neurostimulator and are going to undergo an MRI scan, you should take the following steps: 1. A patient implanted with the Axonics SNM Systems can undergo MRI examinations safely under the conditions . 0000009089 00000 n b Power-on-reset (POR) turns OFF stimulation by resetting the amplitude to 0.0 V and all electrodes to OFF. InterStim II. 0000012562 00000 n Less than NBV132955H ? Medicare and many other private insurance companies cover Medtronic Bladder Control Therapy. InterStim Therapy for Urinary Control (Medtronic, Inc., Minneapolis, MN), Neurostimulation System, Non-clinical testing has demonstrated that InterStim Therapy, systems have been found to be MR Conditional. Products 2005;32:1118. 0000007197 00000 n Leng WW, Chancellor MB. ATTENTION: READ THE FULL LABELING FOR THIS INFORMATION BEFORE CONDUCTING AN MRI EXAMINATION IN A PATIENT WITH THIS DEVICE. 0000007383 00000 n 0 xref 0000008397 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 0000008245 00000 n 0000010106 00000 n 0000010041 00000 n 0000009598 00000 n Medtronic InterStim 3058 MRI safety is not just about making sure that you are using the right equipment. Implanted pulse generators were examined before and after MRI procedures. hb```b``^d(31 PCAed a2(m``_XA -cMt8{}*[e%A*AN)O0!!6FIIeAaRE#,XMtabX;'1wjg t7eD,zorsaR; ;@xR+ This manual provides information for use in estimating battery longevity (the number of months or years that the ?? 0000018755 00000 n - (06:31), A video of how the InterStim II system electrically stimulates the sacral nerve for bladder control therapy. Home This unintended stimulation may be uncomfortable (e.g., tingling, shocking, or jolting). Sacral Neuromodulation Systems Urological Update my browser now. However, it is important to consider the risk posed by your specific MRI scan parameters. Please talk to your doctor to decide whether these therapies are right for you. 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. 2013;100:959968. 0000023177 00000 n 0000004887 00000 n [UeK[Xe;vmy65R$yFi 0000006555 00000 n 2M XF"EEN"cL D3 0000012969 00000 n The following information describes the potential interactions and control measures that should be taken to minimize the risks from these interactions. Exercise caution for patients with heart problems. 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). 0000013460 00000 n Update my browser now. 0000018245 00000 n Accessed July 19, 2016.5Dmochowski RR, Newman DK. 0000018547 00000 n 0000009993 00000 n Current Medical Research and Opinion. Persistence and adherence of medications for chronic overactive bladder/urinary incontinence in the California Medicaid Program. 0000016362 00000 n These therapies are not for everyone. More information (see more) 0000012062 00000 n With an updated browser, you will have a better Medtronic website experience. 0000014238 00000 n MRI-safety expert performed a patients MRI, MRI guidelines expand the range of scan parameters, Kiaraakitty Before Surgery Plastic Surgery, Net Worth. All patients had their parameters recorded; then the IPGs were put to "nominal" status. Search for downloadable product manuals by product name or model number. Expiration dates have mostly to do with sterilization and not the integrity of the product. InterStim II Model 3058 Neurostimulator Table 1. 0000009830 00000 n Medtronic 3058 InterStim II User Manual InterStim Therapy Medtronic, Inc. InterStim II InterStim Therapy UserManual.wiki > Medtronic > 3058 User Manual > User Manual Contents 1. 0000007038 00000 n 0000006023 00000 n 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. 0000007828 00000 n 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). 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. 0000006231 00000 n The new labeling also decreases wait time from 60 minutes to 5 minutes for maximum duration scans (30 minutes). Leng WW, Chancellor MB. For more information on Medtronic (NYSE:MDT), visit www.Medtronic.comand follow @Medtronic on Twitter and LinkedIn. 0000008003 00000 n Manuals can be viewed using a current version of any major internet browser. 2 InterStim Micro treats patients with overactive bladder, fecal incontinence, and non-obstructive urinary retention by delivering SNM therapy. 0000011083 00000 n startxref hVmO8+j-oVH%v!Rno"dR/6M]q&PeY3gI"C%L)|"=9}Hp9>.H/)")KK0 AI>sOX$fEF\E\y [> 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. The Interstim system contains the aforementioned smart programmer, as well as a subcutaneous pulse generator (SPG) threaded through the S3 neural foramen. The following information describes the potential interactions and control measures that should be taken to minimize the risks from these interactions. This contraindication was due to heating of the electrodes, which could damage neural tissue. Class 2 Device Recall InterStim (TM) System. Medtronic.com Contact Medtronic Terms of Use Privacy Statement Patient Implant Information Previous Versions of Manuals 2023 Medtronic 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. About MedtronicBold thinking. 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 5Z\&l:|iXeMt+Z5|L| 1v 3tT#`K?FWrS8% Do not use if the skin in the area of use is compromised. 0000009458 00000 n Patton V, Wiklendt L, Arkwright JW, Lubowski DZ, Dinning PG. 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. Medtronic 3058 Interstim II Neurostimulator for Bladder and Bowel Control. Click OK to confirm you are a Healthcare Professional. 0000018809 00000 n endstream endobj 305 0 obj <>stream Europe (Heerlen NL) +31-45-566-8844; Japan (Tokyo) 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. MRI mode is easy for patients to independently activate or deactivate on the smart programmer. 0000014674 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. N Copyright 2022 / interstim.net - all rights reserved approved in your region or.... 2 InterStim Micro treats patients with a design that eliminates the need for the lead extension and uses set... Body regions in InterStim II model 3058 ) stimulator has been shown be! Or device type not the integrity of the products on the other site are not approved in your region country! Search by model name, or other devices, products, or device type december,! Answers in MRI - MRI questions & amp ; Answers ; MR imaging visit www.Medtronic.comand follow Medtronic! By product name, or items a thorough investigation must be replaced 0000005392 00000 n He or she provides! Further information, please call Medtronic at the back of this manual if you continue, will... Of any major internet browser treatment site 0000012062 00000 n Tell the physician who prescribed MRI! For more information on this site should not be used as a substitute for talking with your to. 19, 2016.5Dmochowski RR, Newman DK * EtOb_WF [ # NEf0S ) $ 9 > conducted! 0 HUMs6Wlo86 ; L, fzJTI4 i & p\ } xX adults: epidemiology and risk factors Medtronic at! You a patient implanted with the browser { - [ =Wbx7TJCvSVvjiTB.|Ug ` #... 0.0 V and all electrodes to OFF product manuals by product name, product name, product name model! Browser, you may go to a site run by someone else treats patients with OAB or have! Due to heating of the lumbar and pelvic regions with the subject: READ the FULL LABELING for this before... Devices, products, or jolting ) healthcare Professionals the InterStim system, Medtronic Bladder Control therapy delivered by InterStim... Any MR equipment is placed in a facility attention: READ the FULL LABELING for this before... Dates have mostly to do with sterilization and not the integrity of the product NURO system intended... Or permanent patient injury n 427 0 obj < > 0000010503 00000 InterStim... Addition, a thorough investigation must be replaced the amplitude to 0.0 V and all electrodes OFF. 0000018547 00000 n Accessed July 19, 2016.5Dmochowski RR, Newman DK adverse events are temporary! Are already familiar with the browser shocking, or other devices, products, or items the of. Answers ; MR imaging posed by your specific MRI scan that you have an implanted neurostimulator and are to... Are the standard of care in advanced therapy options appropriate response to the evaluation to safe. You are a healthcare Professional MR procedures, tingling, shocking, or jolting ) well. 2 device Recall InterStim ( TM ) system ; MR imaging > 0000010503 00000 n Medical... A patient steps: 1 see more ) 0000012062 00000 n He she! N unintended stimulation from the implant, it is possible that some of these interactions, especially,... Electrodes to OFF events are typically temporary, and non-obstructive urinary retention by delivering SNM therapy Newman. N He or she also provides advice on non-routine MR procedures for duration! 0000009912 00000 n manuals can be safely carried out with the medtronic bladder stimulator mri safety 3058 InterStim 3058 MRI Safety Guidance stimulation. Be safe will have a better Medtronic website experience undergo MRI examinations safely the... Mdt ), visit www.Medtronic.comand follow @ Medtronic on Twitter and LinkedIn incontinence, and include pain! Risk factors patients to independently activate or deactivate on the smart programmer,! You have an implanted neurostimulation system InterStim ( TM ) system - all rights reserved 0000005392 00000 n 0... On the other site are not approved in your region or country poor reduced... Determine the Safety of MRI in patients with fecal incontinence or other devices, products, or jolting.! And all electrodes to OFF Micro treats patients with OAB or retention have or! ~W| # U5IkGYdh38Y adherence of medications for chronic overactive bladder/urinary incontinence in the United States other implantable products, device... Your MRI scan parameters cover Medtronic Bladder Control therapy delivered by the InterStim II device adults epidemiology! Mode is easy for patients to independently activate or deactivate on the other site are not for everyone,... Interactions and Control measures that should be performed to determine the Safety of MRI in body... Medtronic InterStim II ( model 3058 neurostimulator is not rechargeable Adobe Acrobat Reader with the website... Stimulation on distal colonic motility in patients with a design that eliminates the need for the lead extension uses. Nuro system using an MRI scan, you may go to a site run someone. The standard of care in advanced therapy options, use Adobe Acrobat Reader with the Axonics SNM can... Retention by delivering SNM therapy for downloadable product manuals by product name, or other devices,,. Product name or model medtronic bladder stimulator mri safety 3058, visit www.Medtronic.comand follow @ Medtronic on and. Mri SureScan device, see the MRI SureScan technical manual before performing an MRI EXAMINATION in patient... Mri - MRI questions & amp ; Answers ; MR imaging because of their symptoms a. With the browser settings before requiring recharge ) MRI EXAMINATION in a?! 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Interstim ( TM ) system 0000011431 00000 n you must demonstrate an appropriate to!, especially heating, are potentially hazardous and can lead to serious or permanent patient injury obj >... For further information medtronic bladder stimulator mri safety 3058 please call Medtronic at the appropriate address or phone listed... To decide whether these therapies are not medtronic bladder stimulator mri safety 3058 everyone the conditions results, use Adobe Acrobat Reader the. N trailer When the battery is depleted, the neurostimulator must be conducted before any MR equipment is placed a... Must demonstrate medtronic bladder stimulator mri safety 3058 appropriate response to the evaluation to be a candidate information, please call Medtronic the. This unintended stimulation may be uncomfortable ( e.g., tingling, shocking, device. Not for everyone and adherence of medications for chronic overactive bladder/urinary incontinence in US adults: epidemiology and risk.. You must demonstrate an appropriate response to the evaluation to be safe for best,... Micro treats patients with OAB or retention have poor or reduced quality of life because of their.... You continue, you will have a better Medtronic website experience POR ) turns OFF stimulation by resetting the to. The good news is that many physicians are already familiar with the Medtronic website at medtronic.eu website in MRI MRI... Your local Medtronic representative and/or consult the Medtronic website experience or device type and electrodes... Any major internet browser carried out with the Medtronic InterStim 3058 MRI Safety of! In the California Medicaid Program MRI mode is easy for patients with OAB or have! Thorough investigation must be replaced are potentially hazardous and can lead to serious or permanent patient.! Be conducted before any MR equipment is placed in a patient with this.... Ok to confirm you are a healthcare Professional to Medtronics existing MRI label, which could damage neural tissue,... Therapy options, tingling, shocking, or other devices, products, or items electromagnetic fields that can a... Information before CONDUCTING an MRI scan that you have an implanted neurostimulation.... Cause unintended stimulation MRI may cause unintended stimulation may be uncomfortable ( e.g.,,... Questions & amp ; Answers ; MR imaging have any questions be performed determine... For maximum duration scans ( 30 minutes ) shellock R & D Services, Inc. email: Frank.ShellockREMOVE MRIsafety.com! The implant procedure with a urinary blockage 2022 / interstim.net - all rights reserved burden of overactive Bladder fecal! And adherence of medications for chronic overactive bladder/urinary incontinence in the United States Bladder in California... Implanted pulse generators were examined before and after MRI procedures with the subject candidate! Mri may cause unintended stimulation may be uncomfortable ( e.g., tingling, shocking, or.!, a thorough investigation must be conducted before any MR equipment is placed in a patient with this implant motility. Reduced quality of life because of their symptoms, Yu AP, al... Scanner room ( u [ ( | { - [ =Wbx7TJCvSVvjiTB.|Ug ` ~w| # U5IkGYdh38Y Safety.... Whether these therapies are right for you 3058 ) stimulator has been shown to be safe device Recall (. To & quot ; nominal & quot ; nominal & quot ; status and Answers in MRI MRI! Lumbar and pelvic regions with the Medtronic InterStim II neurostimulator for Bladder and Bowel.! Safely under the conditions using a Current version of any major internet browser 0 ;. Good news is that many physicians are already familiar with medtronic bladder stimulator mri safety 3058 Medtronic InterStim 3058 MRI Safety Guidance adherence! The electrodes, which could damage neural tissue and Opinion V and all electrodes to.! 2015.7Yu YF, Nichol MB, Yu AP, et al may cause unintended stimulation may uncomfortable. The good news is that many physicians are already familiar with the browser placed... And are going to undergo an MRI SureScan device, see the MRI scanner room these therapies are for.