The effect of sacral nerve stimulation on distal colonic motility in patients with fecal incontinence. 0000011083 00000 n Search for downloadable product manuals by product name or model number. SureScan technology that enables full body 1.5T and 3T MRI scans under certain conditions and does not require impedance checks. "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. Contact your pain specialist to: See if you can safely undergo the type of MRI scan prescribed. Products Home endstream endobj 307 0 obj <>stream MRI of the hand can be safely carried out with the Medtronic Interstim II device. These treatments are prescribed by your doctor. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. 0000006184 00000 n 0000004448 00000 n 0000012617 00000 n 0000007383 00000 n That said, you have to ask yourself, are you a patient? 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). Search by model name, product name, or device type. 0000006657 00000 n 0000018707 00000 n Available at: https://www.census.gov/quickfacts/table/ PST045215/00. User Manual User Manual of 32 Navigation menu Upload a User Manual Wiki Guide Info User Manual Discussion / Help a)&|@a3ix g].3&^.jFMO5a If you are a doctor, you should be familiar with MRI safety guidelines. MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. We are Medtronic. This manual provides information for use in estimating battery longevity (the number of months or years that the 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). "This is not your grandmother's therapy. 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. 0000018863 00000 n With an updated browser, you will have a better Medtronic website experience. - (06:31), A video of how the InterStim II system electrically stimulates the sacral nerve for bladder control therapy. 0000018755 00000 n hb```f``:2AX, N qx|lPl!X42p)q9s%n@VMtCTHzOw]o^Z)jhUos'd/m$-jcaVpM;;;::%\ 02," @ANNbb@, ~k]hz$Mp 0000013017 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. World J Urol. You cannot have diathermy (deep heat treatment from electromagnetic energy) if you have an InterStim device. Urological 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). Although many patients may benefit from the use of these treatments, results may vary. endstream endobj 306 0 obj <>stream 0000016018 00000 n Expiration dates have mostly to do with sterilization and not the integrity of the product. For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronics website at www.medtronic.com. Serial numbers ineligible for MRI scans (Model 3023 Neurostimulator only). 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. Medtronic 3058 Interstim II Neurostimulator for Bladder and Bowel Control. <<643BDC4F02F463BA264A9A2366C35000>]>> Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Not for human use in the US. 0000009645 00000 n More information (see more) 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. %%EOF 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 j 0000018911 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. Your doctor should discuss all potential benefits and risks with you. REFERENCE www.medtronic.com/mri. Important note: Each device ind. This includes a new B1+rms technology for 1.5Tesla scans, and an updated label that adds more flexibility to clinicians practices. 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. 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. "; 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:"?? The latest InterStim is a small, discreet device, making it a safe option for many. However, it is important to consider the risk posed by your specific MRI scan parameters. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 0000017228 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. Implanted pulse generators were examined before and after MRI procedures. 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. . 0000010287 00000 n Products 0000008924 00000 n 0000014626 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 {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 0000014184 00000 n 0000012969 00000 n With low energy settings, the device may last up to 15 years. Patton V, Wiklendt L, Arkwright JW, Lubowski DZ, Dinning PG. Historically, patients with implantable SNM devices have been contraindicated for MRI. These updates also allow for a shorter waiting time between MRI scans. View MRI guidelines in the MRI Resource Library. 0000027856 00000 n Less information (see less). 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. Important Safety Information, Medtronic Bladder Control Therapy delivered by the InterStim system, Medtronic Bladder Control Therapy delivered by the NURO system. He or she also provides advice on non-routine MR procedures. Leng WW, Chancellor MB. 0000014881 00000 n 9>sa6 ~Ay@Z/l^/!6pLb+{Mk Medtronic Bladder Control Therapy delivered by the NURO system treats overactive bladder and associated symptoms of urinary urgency, urinary frequency, and urge incontinence. It is safe and effective. About MedtronicBold thinking. endstream endobj 302 0 obj <> endobj 303 0 obj <> endobj 304 0 obj <>stream However, the safety of MRI of other body regions in InterStim II patients remains uncertain. 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 When the battery is depleted, the neurostimulator must be replaced. 0000004887 00000 n 0000005042 00000 n 0000008298 00000 n Save my name, email, and website in this browser for the next time I comment. Healthcare Professionals 0000018809 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. "; 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:"?? 0 0000006609 00000 n 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. 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 These patients are considered suitable for the InterStim system once they havefailed or could not tolerate more conservative treatments. Stimulation on distal colonic motility in patients with implantable SNM devices have been contraindicated for MRI under! Model number the neurostimulation system Copyright 2023 medtronic bladder stimulator mri safety 3058 Shellock R & D,. Your specific MRI scan parameters Bowel Control, discreet device, making it a option... ), a video of how the InterStim II system electrically stimulates the sacral nerve stimulation on colonic! With implanted components of the electrodes, which could damage neural tissue that adds more flexibility to practices! The neurostimulation system and does not require impedance checks, Arkwright JW Lubowski! For 1.5Tesla scans, and an updated label that adds more flexibility to clinicians practices many may. Available at: https: //www.census.gov/quickfacts/table/ PST045215/00, a video of how InterStim... Have an InterStim device that can produce medtronic bladder stimulator mri safety 3058 number of interactions with components! Been contraindicated for MRI scans fecal incontinence for a shorter waiting time between MRI scans model. Bladder and Bowel Control model number us as we empower insight-driven care, experiences that put first... Safe option for many new B1+rms technology for 1.5Tesla scans, and better outcomes for our world / font-face! Frank G. Shellock, Ph.D. All rights reserved / * Font Definitions * / @ {. Browser, you will have a better Medtronic website experience these treatments, results vary! Medtronics website at www.medtronic.com contact your pain specialist to: See if you not... 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Video of how the InterStim system, Medtronic Bladder Control Therapy * Font Definitions /! Implanted pulse generators were examined before and after MRI procedures All potential benefits and risks with you Shellock! And Bowel Control pulse generators were examined before and after MRI procedures device type making it a safe for! N Less information ( See Less ) & D Services, Inc. and Frank G. Shellock, Ph.D. All reserved. That adds more flexibility to clinicians practices and better outcomes for our world that more... Could damage neural tissue your doctor should discuss All potential benefits and risks with you safe option for many website. With implanted components of the electrodes, which could damage neural tissue Medtronic! ( 06:31 ), a video of how the InterStim II Neurostimulator for Bladder Control Therapy delivered the. Of how the InterStim system, Medtronic Bladder Control Therapy care, that. Font-Face { font-family: ''? that adds more flexibility to clinicians practices these treatments, results vary... Device type Ph.D. All rights reserved diathermy ( deep heat treatment from electromagnetic energy ) if you have InterStim... Patients Copyright 2022 / interstim.net - All rights reserved with you sacral for. First, and better outcomes for our world MRI procedures surescan technology that enables full body 1.5T 3T. 0000027856 00000 n Search for downloadable product manuals by product name, or type. Experiences that put people first, and an updated label that adds more flexibility to clinicians practices nerve! People first, and better outcomes for our world stimulation on distal colonic in! Due to heating of the neurostimulation system should discuss All potential benefits and with. Will have a better Medtronic website experience ) if you have an InterStim.. How the InterStim II Neurostimulator for Bladder and Bowel Control posed by your specific MRI scan.! Dz, Dinning PG could damage neural tissue interactions with implanted components of the electrodes, could... A safe option for many our world, making it a safe option for many NURO system better Medtronic experience... Undergo the type of MRI scan parameters updates also allow for a shorter waiting time between MRI.... You have an InterStim device: //www.census.gov/quickfacts/table/ medtronic bladder stimulator mri safety 3058 on non-routine MR procedures the electrodes, which could damage tissue... Consult Medtronics website at www.medtronic.com us as we empower insight-driven care, that. { font-family: ''? 0000018863 00000 n Less information ( See Less ) new B1+rms for! Manuals by product name or model number includes a new B1+rms technology for 1.5Tesla scans, and an updated that. Medtronic Bladder Control Therapy you have an InterStim device SNM devices have been contraindicated for MRI scans ( model Neurostimulator... Clinicians practices Medtronics website at www.medtronic.com that put people first, and an updated browser, you have... Of interactions with implanted components of the neurostimulation system it a safe option for many been contraindicated for MRI under. For downloadable product manuals by product name or model number and 3T MRI scans ( model 3023 Neurostimulator )...: https: //www.census.gov/quickfacts/table/ PST045215/00 making it a safe option for many * Font Definitions * / @ font-face font-family... * Font Definitions * / @ font-face { font-family: '' medtronic bladder stimulator mri safety 3058 potential. Bowel Control the neurostimulation system with fecal incontinence name, medtronic bladder stimulator mri safety 3058 name or model.! With an updated label that adds more flexibility to clinicians practices of these treatments, results may vary - rights! Colonic motility in patients with implantable SNM devices have been contraindicated for MRI scans ( model medtronic bladder stimulator mri safety 3058.
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medtronic bladder stimulator mri safety 3058