0000014674 00000 n User Manual User Manual of 32 Navigation menu Upload a User Manual Wiki Guide Info User Manual Discussion / Help hVmO8+j-oVH%v!Rno"dR/6M]q&PeY3gI"C%L)|"=9}Hp9>.H/)")KK0 AI>sOX$fEF\E\y [> 0000016760 00000 n 0000011431 00000 n 0000013358 00000 n When the battery is depleted, the neurostimulator must be replaced. 0000010551 00000 n 0000007795 00000 n Those lucky few will benefit from this devices latest enhancements. This includes a new B1+rms technology for 1.5Tesla scans, and an updated label that adds more flexibility to clinicians practices. 0000016458 00000 n 0000023719 00000 n 0000002333 00000 n More information (see more) Implanted pulse generators were examined before and after MRI procedures. However, it is important to consider the risk posed by your specific MRI scan parameters. 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. The neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. Patients InterStim II Model 3058 Neurostimulator Table 1. Exercise caution for patients with heart problems. 0000009089 00000 n 0000013412 00000 n These patients are considered suitable for the InterStim system once they havefailed or could not tolerate more conservative treatments. ?? 0000006684 00000 n 0000013460 00000 n Contact Medtronic at the appropriate address or phone number listed at the back of this manual if you have any questions. 0000012800 00000 n Impact of overactive bladder on women in the United States: results of anational survey. About MedtronicBold thinking. 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. ' a9.aacz3CSoTz)_%v 0000000016 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. You must demonstrate an appropriate response to the evaluation to be a candidate. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Adverse events are typically temporary, and include mild pain, minor inflammation and bleeding near treatment site. SureScan technology that enables full body 1.5T and 3T MRI scans under certain conditions and does not require impedance checks. These instructions do not apply to other implantable products, or other devices, products, or items. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. How sacral nerve stimulation neuromodulation works. "As we celebrate 25 years of InterStim this year, we're bullish about our next chapter in patient-focused therapy innovation. 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. 0000023883 00000 n 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'[. See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. %%EOF 0000009598 00000 n 427 0 obj <> endobj The new labeling also decreases wait time from 60 minutes to 5 minutes for maximum duration scans (30 minutes). Aside from the aforementioned medical conditions, there is no shortage of people with urinary tract infections (UTIs). 0000014402 00000 n Medtronic 3058 Interstim II Neurostimulator for Bladder and Bowel Control. POR can occur when there is a temporary fluctuation in battery voltage (eg . The Interstim system contains the aforementioned smart programmer, as well as a subcutaneous pulse generator (SPG) threaded through the S3 neural foramen. This small device will improve patient satisfaction and reduce hospital readmissions. 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). The good news is that many physicians are already familiar with the subject. 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. 0000004045 00000 n InterStim systems are the standard of care in advanced therapy options . &)k1}Ym@,C#k[q}[n 0000011083 00000 n 0000014626 00000 n ;zrz'm,E*|3;aB.v` qRy 0000065437 00000 n 0000018911 00000 n Under certain conditions; see approved labeling for details. However, if the conditions for safe MRI are Important Safety Information, Medtronic Bladder Control Therapy delivered by the InterStim system, Medtronic Bladder Control Therapy delivered by the NURO system. 9>sa6 ~Ay@Z/l^/!6pLb+{Mk 0000007197 00000 n 0000010222 00000 n I~!#N*~aw+*EtOb_WF[#NEf0S)$9>! Br J Surg. Home It should be used after you have tried other treatments such as medications and behavioral therapy and they have not worked, or you could not tolerate them. 0000009830 00000 n 0000026803 00000 n 0000016362 00000 n Our Mission to alleviate pain, restore health, and extend life unites a global team of 90,000+ passionate people across 150 countries. 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. "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. 0000005793 00000 n Click OK to confirm you are a Healthcare Professional. 0000018493 00000 n InterStim II. MRI-safety expert performed a patients MRI, MRI guidelines expand the range of scan parameters, Kiaraakitty Before Surgery Plastic Surgery, Net Worth. `ir8s]:FQpyibR-`,}8my) b&(bN (o|w o For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu website. 0000027823 00000 n In everything we do, we are engineering the extraordinary. 5Z\&l:|iXeMt+Z5|L| 1v 3tT#`K?FWrS8% Search for downloadable product manuals by product name or model number. Home "; 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;} @page WordSection1 {size:8.5in 11.0in; margin:1.0in 1.25in 1.0in 1.25in; mso-header-margin:.5in; mso-footer-margin:.5in; mso-paper-source:0;} div.WordSection1 {page:WordSection1;} --> www.medtronic.com/mri. Healthcare Professionals <> This contraindication was due to heating of the electrodes, which could damage neural tissue. 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: ? A patient implanted with the Axonics SNM Systems can undergo MRI examinations safely under the conditions . 0000002263 00000 n 0000009993 00000 n The Interstim II system may be suitable for most people because it's simple, convenient and lower maintenance.3. Considering that the InterStim is a ubiquitous presence in the bladder department, MRI safety is a must. 0000023451 00000 n 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. 0000018445 00000 n 0000016814 00000 n 0000018197 00000 n 0000006555 00000 n 884 0 obj 0000018547 00000 n Regulatory Statements 2. The neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. Between NBV133037H and NBV133063H ? 0000027445 00000 n The InterStim II system is the only recharge-free, long-termSNM system that lets you get full-body* MRI scans. 0000008350 00000 n Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. Contact Medtronic at the appropriate address or phone number listed at the back of this manual if you have any questions. 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. 0000007625 00000 n These instructions do not apply to other implantable products, or other devices, products, or items. Please talk to your doctor to decide whether these therapies are right for you. Manuals can be viewed using a current version of any major internet browser. Medtronic Interstim 3058 MRI Safety MRI of the hand MRI of the hand can be safely carried out with the Medtronic Interstim II device. 0000006609 00000 n Current Medical Research and Opinion. 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 . Update my browser now. "; 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:"?? 0000004494 00000 n Questions and Answers in MRI - MRI Questions & Answers; MR imaging . stream Historically, patients with implantable SNM devices have been contraindicated for MRI. However, further studies should be performed to determine the safety of MRI in other body regions in InterStim II patients. 349 0 obj <>stream 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. In order to ensure safety in MR facilities, all personnel involved must understand safety procedures and be willing to communicate with each other. 0000013017 00000 n [UeK[Xe;vmy65R$yFi 0000023020 00000 n The purpose of the MR safety expert is to minimize risk and optimize scan plans. 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. Not for human use in the US. 0000003266 00000 n 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. Medtronic 3058 InterStim II User Manual InterStim Therapy Medtronic, Inc. InterStim II InterStim Therapy UserManual.wiki > Medtronic > 3058 User Manual > User Manual Contents 1. Products De Wachter S. et al New Technologies and Applications in Sacral Neuromodulation: An Update Adv Ther 37, 637-643 (2020). 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 . 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. 0000124808 00000 n 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. Rh)b#0a(Z)#!H Bb*acH@L Q 9 , p043/aeSe3JEANr3>-u8wFXGp. {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 2005;32:11-18. 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. Prevalence and burden of overactive bladder in the United States. Medtronic.com Contact Medtronic Terms of Use Privacy Statement Patient Implant Information Previous Versions of Manuals 2023 Medtronic 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. Patton V, Wiklendt L, Arkwright JW, Lubowski DZ, Dinning PG. World Population Prospects: The 2010 Revision, CD-ROM Edition.3Whitehead WE, Borrud L, Goode PS, et al. 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. Due to increased risk of neurostimulator damage, patients implanted with InterStim Model 3023 Neurostimulators with the following serial numbers should not have MRI scans. Urol Clin North Am. It uses an implanted stimulator to deliver electrical pulses through a lead wire to electrodes located near the sacral nerve. For best results, use Adobe Acrobat Reader with the browser. 0000016308 00000 n 2007;23:65-76.6Leede Research, "Views on OAB: A Study for the National Association of Continence." Learn the parameters of patient selection for bladder control and bowel control. 4.2. 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 This small electro-optical device is not only a cool-looking device, but it does not affect the quality of your MRI images. 0000001682 00000 n Your doctor should discuss all potential benefits and risks with you. 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. (8^T?Z$$0r 0000015308 00000 n You cannot have diathermy (deep heat treatment from electromagnetic energy) if you have an InterStim device. Information on this site should not be used as a substitute for talking with your doctor. Less information (see less). ?? Serial numbers ineligible for MRI scans (Model 3023 Neurostimulator only). Actual results may differ materially from anticipated results. 0000010041 00000 n %PDF-1.5 % 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. 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. p;X``pe`.)N]KA@!0834X@wP t(p 4qgp)h` j{ 0000004995 00000 n Europe (Heerlen NL) +31-45-566-8844; Japan (Tokyo) 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. View MRI guidelines in the MRI Resource Library. Medtronic Manuals: Region Manual Library Instructions for use and product manuals for healthcare professionals Please select your region. 0000014881 00000 n 0000006753 00000 n 756 0 obj 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. 0000012617 00000 n endstream endobj 428 0 obj <. 0000009912 00000 n That said, you have to ask yourself, are you a patient? InterStim II. Expiration dates have mostly to do with sterilization and not the integrity of the product. 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. }$Y? @J9z6{,RLZtR!zbh*8 l2azr&_4=OG$Vkwy?5 P&Dg*[@K6WrqFKe]3 Spinal Cord Stimulation, SureScan MRI Version, Medtronic, Inc. . However, several studies have shown no serious adverse outcomes. 0000001914 00000 n 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: +yLKxN5F`W82r J Manag Care Pharm. - (06:31), A video of how the InterStim II system electrically stimulates the sacral nerve for bladder control therapy. %PDF-1.4 % With an updated browser, you will have a better Medtronic website experience. 2003 May;20(6):327-336.2United Nations, Department of Economic and Social Affairs, Population Division (2011). 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: 0000023686 00000 n Axonics SNM Systems are MRI conditionally safe for: 1.5T and 3T full-body MRI scans. The effect of sacral nerve stimulation on distal colonic motility in patients with fecal incontinence. 0000011192 00000 n The following information describes the potential interactions and control measures that should be taken to minimize the risks from these interactions. This site is Exclusively Sponsored by BRACCO. 0000000696 00000 n %%EOF 301 0 obj <> endobj 0000010599 00000 n 2005;8(4)495-505.8Yeaw J, Benner JS, Walt JG, Sian S, Smith DB, et al. REFERENCE