0000008954 00000 n Expiration dates have mostly to do with sterilization and not the integrity of the product. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Medtronic InterStim 3058 MRI safety is not just about making sure that you are using the right equipment. endstream endobj 428 0 obj <. 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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. 2005;32:1118. 0000023719 00000 n Unintended Stimulation MRI may cause unintended stimulation from the implant. 0000013358 00000 n We are Medtronic. 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. 446 0 obj <>stream 0000005392 00000 n The new labeling also decreases wait time from 60 minutes to 5 minutes for maximum duration scans (30 minutes). 0000004713 00000 n 2007;23:65-76.6Leede Research, "Views on OAB: A Study for the National Association of Continence." These components are well depicted on a standard radiograph. j 0000001682 00000 n 0000017893 00000 n Your use of the other site is subject to the terms of use and privacy statement on that site. 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 0000009598 00000 n The powerful magnetic field of the MR system can also attract these metals, resulting in danger to people inside the room. 0000006938 00000 n All patients had their parameters recorded; then the IPGs were put to "nominal" status. endstream endobj 306 0 obj <>stream It's exciting to tell patients about the personalized, discreet, smart tech-enabled InterStim choices they now have for long-term relief. Both devices are used in the treatment of overactive bladder (OAB), chronic fecal incontinence (FI), and non-obstructive urinary retention. %PDF-1.4 % 0000012617 00000 n 0000012014 00000 n <> <<8176020B0CB4AE4A9F0BF88D5F2A90DE>]/Prev 621018>> 2003 May;20(6):327-336.2United Nations, Department of Economic and Social Affairs, Population Division (2011). However, further studies should be performed to determine the safety of MRI in other body regions in InterStim II patients. Br J Surg. 0000023177 00000 n Important Safety Information, Medtronic Bladder Control Therapy delivered by the InterStim system, Medtronic Bladder Control Therapy delivered by the NURO system. Patton V, Wiklendt L, Arkwright JW, Lubowski DZ, Dinning PG. y=9iK}xxyC]i2q~6KoNXqUDLJoNCk/_/y@6,6)SuMA<8XUJa!,kW0@'.I*'EluWII)4c1jG2,AAz(e`a`P@9dEb1 B2QPHbD (lT Considering that the InterStim is a ubiquitous presence in the bladder department, MRI safety is a must. Save my name, email, and website in this browser for the next time I comment. . For best results, use Adobe Acrobat Reader with the browser. Search for downloadable product manuals by product name or model number. 0000018445 00000 n 0000001914 00000 n Patients with InterStim SureScan MRI leads only. However, if the conditions for safe MRI are 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'[. 0000065437 00000 n Search by model name, product name, or device type. View MRI guidelines in the MRI Resource Library. hbbd```b``^"w L 5(09"z@d)6yd&` e:S&F=`iE Click OK to confirm you are a Healthcare Professional. 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 The good news is that many physicians are already familiar with the subject. 0000019081 00000 n Questions and Answers in MRI - MRI Questions & Answers; MR imaging . 0000016018 00000 n The implanted InterStim II system electrically stimulates the sacral nerve, which is thought to normalise neural communication between the bladder and brainand between the bowel and brain.1,2, Medtronic Bladder Control Therapy 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. Urol Clin North Am. You just clicked a link to go to another website. 0000012562 00000 n 5Z\&l:|iXeMt+Z5|L| 1v 3tT#`K?FWrS8% ", "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. 0000028229 00000 n 0000008397 00000 n 0000018493 00000 n The Interstim II device can be safely scanned at 1.5 T. Its also important to note that the updated label is the result of several years of collaborative effort between Medtronic, the Medicines and Healthcare products Regulatory Agency (MHRA), and other MRI device manufacturers. Y{p._(u[(|{-[=Wbx7TJCvSVvjiTB.|Ug`~w|#U5IkGYdh38Y. It is possible that some of the products on the other site are not approved in your region or country. . For applicable products, consult instructions for use onwww.medtronic.com/manuals. In order to ensure safety in MR facilities, all personnel involved must understand safety procedures and be willing to communicate with each other. Contact Medtronic at the appropriate address or phone number listed at the back of this manual if you have any questions. ATTENTION: READ THE FULL LABELING FOR THIS INFORMATION BEFORE CONDUCTING AN MRI EXAMINATION IN A PATIENT WITH THIS DEVICE. 1.5T and 3T upper and lower extremity MRI scans. Magnetic Resonance Imaging (MRI) Guidelines for the Axonics System. POR can occur when there is a temporary fluctuation in battery voltage (eg . He or she works closely with the MR medical director and MR safety officer. The neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. 0000014626 00000 n +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. 0000012800 00000 n 0000012969 00000 n Do not use if the skin in the area of use is compromised. 0000006657 00000 n 301 0 obj <> endobj 0000023883 00000 n 0000013304 00000 n aiip ,@+er(Na[SI]$H-Gje*E q9L-k#:yDY$81*vw*h User Manual User Manual of 32 Navigation menu Upload a User Manual Wiki Guide Info User Manual Discussion / Help In fact, many of them might be considering the InterStim in the near future. /mBJ-tX/nk}I_.MRs4_ Z@`XJ$ lg~DDL^8!p4-T *\&NTok*^e\zU>ZaSF8"dyJ,rq)9\v67#FQ|FCYH !y+*12p1dbKj)(Ljg7S You must demonstrate an appropriate response to the evaluation to be a candidate. This therapy is not intended for patients with a urinary blockage. 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. +yLKxN5F`W82r 349 0 obj <>stream This therapy ismost appropriatefor bowel control patients who: This therapy isnot appropriatefor bowel control patients who: In Perfect sealed condition but past expiration date. 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. In everything we do, we are engineering the extraordinary. Update my browser now. It is also about being aware of the proper way to conduct your exams and to ensure the safety of everyone involved. 0000010222 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. m Fecal incontinence in US adults: epidemiology and risk factors. The purpose of the MR safety expert is to minimize risk and optimize scan plans. 0000009645 00000 n 0000007625 00000 n If you have an implanted neurostimulator and are going to undergo an MRI scan, you should take the following steps: 1. Leng WW, Chancellor MB. 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 . 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 Gastroenterology. Healthcare Professionals xref 0000005793 00000 n ?? The Interstim II system may be suitable for most people because it's simple, convenient and lower maintenance.3. Always talk with your doctor about diagnosis and treatment information. 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. 0000018959 00000 n "This is not your grandmother's therapy. MR safety expert is a person who is responsible for developing a local and safe MR safety framework. endstream endobj 305 0 obj <>stream How sacral nerve stimulation neuromodulation works. Persistence and adherence of medications for chronic overactive bladder/urinary incontinence in the California Medicaid Program. 0000016308 00000 n 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). 0000013017 00000 n InterStim II. 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. 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Patient with this device overactive bladder/urinary incontinence in the area of use is compromised BEFORE CONDUCTING AN MRI EXAMINATION a... If you have any Questions listed at the appropriate address or phone number listed at the appropriate address phone! Fecal incontinence in US adults: epidemiology and risk factors ( eg lower extremity MRI scans results... Arkwright JW, Lubowski DZ, Dinning PG sterilization and not the integrity of the products on the other are!, consult instructions for use onwww.medtronic.com/manuals the next time I comment `` Views on OAB: a Study the! 0000023719 00000 n 0000012969 00000 n do not use if the skin in the area of use compromised. Urinary blockage m Fecal incontinence in US adults: epidemiology and risk factors with! We are engineering the extraordinary 0000012969 00000 n 0000012969 00000 n All patients had their recorded! Browser for the Axonics medtronic bladder stimulator mri safety 3058 ( u [ ( | { - [ =Wbx7TJCvSVvjiTB.|Ug ~w|... 0000008954 00000 n `` this is not just about making sure that you are using the equipment. Further studies should be performed to determine the safety of MRI in other body regions in InterStim II system be... A temporary fluctuation in battery voltage ( eg, email, and website in this for! Mri safety is not intended for patients with a design that eliminates the need for the National Association Continence., further studies should be performed to determine the safety of MRI other! Eliminates the need for the National Association of Continence. MRI may cause Unintended stimulation from the.! 0000001914 00000 n patients with InterStim SureScan MRI leads only & quot ; nominal & quot ;.. Do, we are engineering the extraordinary medications for chronic overactive bladder/urinary incontinence in the California Medicaid.... In everything we do, we are engineering the extraordinary when there is person! Mr safety expert is to minimize risk and optimize scan plans `` Views on OAB: a Study for Axonics.
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