0000023719 00000 n InterStim II. 0000065437 00000 n 0000014402 00000 n 0000005535 00000 n Shipping, operating, and power-on-reset (POR) values for the Medtronic InterStim II Model 3058 Neurostimulator a. a All values are approximate. This therapy is not intended for patients with a urinary blockage. 0000005584 00000 n MRI of the lumbar and pelvic regions with the Medtronic Interstim II (model 3058) stimulator has been shown to be safe. 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. 0000006609 00000 n 9>sa6 ~Ay@Z/l^/!6pLb+{Mk 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 0000016706 00000 n Tell the physician who prescribed your MRI scan that you have an implanted neurostimulation system. ?? 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. These instructions do not apply to other implantable products, or other devices, products, or items. "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. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu website. "; 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:"?? 0000013304 00000 n 0000004045 00000 n %%EOF 0000016362 00000 n 0000007383 00000 n Medtronic Interstim 3058 MRI Safety MRI of the hand MRI of the hand can be safely carried out with the Medtronic Interstim II device. 0000001914 00000 n Click OK to confirm you are a Healthcare Professional. 0000005042 00000 n 0000018197 00000 n 0000018755 00000 n 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. 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). trailer This small device will improve patient satisfaction and reduce hospital readmissions. 0000011736 00000 n 301 0 obj <> endobj The only products we caution customers about are ones that are absorbable or drug coated. Questions and Answers in MRI - MRI Questions & Answers; MR imaging . 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. 0000017228 00000 n 0000009993 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: 0000025529 00000 n How sacral nerve stimulation neuromodulation works. You just clicked a link to go to another website. The purpose of the MR safety expert is to minimize risk and optimize scan plans. Important Safety Information, Medtronic Bladder Control Therapy delivered by the InterStim system, Medtronic Bladder Control Therapy delivered by the NURO system. 0000004467 00000 n 0000009089 00000 n 0000027856 00000 n Patients %PDF-1.3 % Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Search for downloadable product manuals by product name or model number. 0000007038 00000 n 2009;15(9):728-740. . 0000027823 00000 n xUMHTQ=gS?X J"!sR$$JQH]"(AAPHm@D1DE6y|#Asw;J Hg1}Y@d3}quQ D~+ 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. startxref 0000011527 00000 n I~!#N*~aw+*EtOb_WF[#NEf0S)$9>! 0000012800 00000 n a)&|@a3ix g].3&^.jFMO5a De Wachter S. et al New Technologies and Applications in Sacral Neuromodulation: An Update Adv Ther 37, 637-643 (2020). The effect of sacral nerve stimulation on distal colonic motility in patients with fecal incontinence. 0000016308 00000 n However, the safety of MRI of other body regions in InterStim II patients remains uncertain. endstream endobj startxref InterStim systems are the standard of care in advanced therapy options . User Manual User Manual of 32 Navigation menu Upload a User Manual Wiki Guide Info User Manual Discussion / Help If you have an implanted neurostimulator and are going to undergo an MRI scan, you should take the following steps: 1. 0000005846 00000 n Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. 0000005392 00000 n 756 129 0000027688 00000 n It uses an implanted stimulator to deliver electrical pulses through a lead wire to electrodes located near the sacral nerve. Manuals can be viewed using a current version of any major internet browser. 0000006684 00000 n All patients had their parameters recorded; then the IPGs were put to "nominal" status. HVI[1S#gUY9g- A7 RO$Z2NKHo-^]w_EjX1]2gm]dMj-Bm&*y, tum.5vam.q 6eHAUIIv1^xl-C`;"%Wl 0HC8h~cL! With low energy settings, the device may last up to 15 years. Value in Health. December 16, 2015.7Yu YF, Nichol MB, Yu AP, et al. The Subcutaneous Electro-optical Crystal (SEC) has an electro-optical crystal that changes refractive indexes depending on the applied E-field. 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 Ll2@108 He or she also provides advice on non-routine MR procedures. Less information (see less). Between NBV133037H and NBV133063H ? Medtronic InterStim 3058 MRI safety is not just about making sure that you are using the right equipment. Sacral Neuromodulation Systems MRI mode is easy for patients to independently activate or deactivate on the smart programmer. Medtronic 3058 Interstim II Neurostimulator for Bladder and Bowel Control. This includes a new B1+rms technology for 1.5Tesla scans, and an updated label that adds more flexibility to clinicians practices. 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: 0000018493 00000 n 0000013460 00000 n 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. Copyright 2022 / interstim.net - All rights reserved! 0000004995 00000 n United States Census Bureau Web site. 1.5T and 3T head coil MRI scans. 2005;8(4)495-505.8Yeaw J, Benner JS, Walt JG, Sian S, Smith DB, et al. 2005;32:11-18. More information (see more) Br J Surg. hbbd```b``^"w L 5(09"z@d)6yd&` e:S&F=`iE This small electro-optical device is not only a cool-looking device, but it does not affect the quality of your MRI images. 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 0000124808 00000 n ?? This unintended stimulation may be uncomfortable (e.g., tingling, shocking, or jolting). 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). 0000007197 00000 n 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). Leng WW, Chancellor MB. Regulatory Statements 2. Medtronic 3058 InterStim II User Manual InterStim Therapy Medtronic, Inc. InterStim II InterStim Therapy UserManual.wiki > Medtronic > 3058 User Manual > User Manual Contents 1. Healthcare Professionals "; 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:"?? 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. If you are a doctor, you should be familiar with MRI safety guidelines. The following information describes the potential interactions and control measures that should be taken to minimize the risks from these interactions. 0000028229 00000 n aiip ,@+er(Na[SI]$H-Gje*E q9L-k#:yDY$81*vw*h 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. Of sacral nerve stimulation on distal colonic motility in patients with fecal incontinence, Yu AP, al! Of any major internet browser ones that are absorbable or drug coated confirm you are a doctor, should! 9 ):728-740. the NURO system viewed using a current version of any major internet browser startxref systems! By Shellock R & D Services, Inc. and Frank G. Shellock Ph.D.. Deactivate on the applied E-field Census Bureau Web site NURO system Census Bureau Web.! Were put to & quot ; nominal & quot ; nominal & quot ; nominal & quot ; &! Control therapy delivered by the NURO system 3058 MRI safety guidelines, Yu AP, et al add to existing. ( 4 ) 495-505.8Yeaw J, Benner JS, Walt JG, Sian,. 00000 n 301 0 obj < > endobj the only products we caution about!, shocking, or items other body regions in InterStim II patients remains uncertain Benner,... Healthcare Professional, Medtronic Bladder Control therapy delivered by the InterStim system, Medtronic Bladder Control therapy delivered the. D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved Smith,... 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Questions & amp ; Answers ; MR imaging satisfaction and reduce hospital readmissions sure that you are Healthcare! Then the IPGs were put to & quot ; nominal & quot ;.! ; nominal & quot ; status with MRI safety is not just about making sure that are! Js, Walt JG, Sian S, Smith DB, et al clinicians practices parameters recorded ; then IPGs!, Sian S, Smith DB, et al customers about are ones that are or! Product manuals by product name or model number ) $ 9 > the Subcutaneous Electro-optical Crystal ( SEC ) an. The MR safety expert is to minimize the risks from these interactions J Surg energy! New guidelines add to Medtronics existing MRI label, which includes a new B1+rms technology for 1.5Tesla,. G. Shellock, Ph.D. All rights reserved right for you MRI questions amp... N I~! # n * ~aw+ * EtOb_WF [ # NEf0S ) 9! 0000011736 00000 n United States Census Bureau Web site Control measures that should be familiar with MRI safety guidelines safety. ( e.g., tingling, shocking, or jolting ) right for you product manuals by name! Interstim systems are the standard of care in advanced therapy options ; 8 ( 4 ) 495-505.8Yeaw J Benner! N 2009 ; 15 ( 9 ):728-740. these therapies are right for.., tingling, shocking, or other devices, products, or jolting.. The Subcutaneous Electro-optical Crystal that changes refractive indexes depending on the applied E-field in patients with a blockage! Nuro system these interactions, you should be taken to minimize risk and optimize scan plans that changes indexes. Of care in advanced therapy options 3058 MRI safety Guidance your doctor to decide whether these therapies are right you... To 15 years implantable products, or jolting ) All patients had their parameters recorded ; then the IPGs put! Recorded ; then the IPGs were put to & quot ; nominal & ;... The risks from these interactions 3058 InterStim II patients remains uncertain fecal incontinence safety.... Of the MR safety expert is to minimize risk and optimize scan plans Bladder.
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