Contact Medtronic at the appropriate address or phone number listed at the back of this manual if you have any questions. Click OK to confirm you are a Healthcare Professional. 0000002333 00000 n 1Stewart WF, et al. Pelvic floor disorders network. Between NBV133037H and NBV133063H ? Aside from the aforementioned medical conditions, there is no shortage of people with urinary tract infections (UTIs). MRI, inform the MRI technologist immediately and then contact your doctor. Information on this site should not be used as a substitute for talking with your doctor. 0000009317 00000 n However, several studies have shown no serious adverse outcomes. For best results, use Adobe Acrobat Reader with the browser. 0000015308 00000 n 0000009598 00000 n Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. It's exciting to tell patients about the personalized, discreet, smart tech-enabled InterStim choices they now have for long-term relief. December 16, 2015.7Yu YF, Nichol MB, Yu AP, et al. Ll2@108 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. 0000009645 00000 n 0000005535 00000 n 0000008954 00000 n "As we celebrate 25 years of InterStim this year, we're bullish about our next chapter in patient-focused therapy innovation. 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). 0000023020 00000 n 349 0 obj <>stream The neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. 0000014402 00000 n Adverse events are typically temporary, and include mild pain, minor inflammation and bleeding near treatment site. 0000012800 00000 n 1-(800)-723-4636 (Tachy) 1-(800)-505-4636 (Brady) International Technical Centers. 0000007383 00000 n Rh)b#0a(Z)#!H Bb*acH@L Q 9 , p043/aeSe3JEANr3>-u8wFXGp. 2009;15(9):728-740. 0000004448 00000 n The InterStim II system a recharge-free, long-term therapy that lets patients get full-body* MRI scans. 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: 0000005225 00000 n 2005;32:1118. He or she works closely with the MR medical director and MR safety officer. We do not review or control the content on non-Medtronic sites, and we are not responsible for any business dealings or transactions you have there. Several precautions should be taken, including selecting the appropriate coil and positioning the patient outside the MRI scanner room. 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 . 0000018547 00000 n 0000027445 00000 n 0000018707 00000 n 0000010041 00000 n endstream endobj 428 0 obj <. 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 0000014136 00000 n 0000006938 00000 n Medtronic InterStim 3058 MRI safety is not just about making sure that you are using the right equipment. 2005;32:11-18. 0000010599 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. Products Important note: Each device ind. %%EOF [UeK[Xe;vmy65R$yFi 2 InterStim Micro treats patients with overactive bladder, fecal incontinence, and non-obstructive urinary retention by delivering SNM therapy. When the battery is depleted, the neurostimulator must be replaced. 0000000696 00000 n Accessed July 19, 2016.5Dmochowski RR, Newman DK. "This is not your grandmother's therapy. 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. Safety and effectiveness have not been established for pregnancy and delivery; patients under the age of 16; or for patients with neurological disease origins. 301 0 obj <> endobj 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 It is also about being aware of the proper way to conduct your exams and to ensure the safety of everyone involved. 0000009182 00000 n <> The following information describes the potential interactions and control measures that should be taken to minimize the risks from these interactions. Your use of the other site is subject to the terms of use and privacy statement on that site. 0000023451 00000 n 0000006555 00000 n 0000006184 00000 n 446 0 obj <>stream Prevalence and burden of overactive bladder in the United States. 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 "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. Considering that the InterStim is a ubiquitous presence in the bladder department, MRI safety is a must. 0000016018 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. 0000018055 00000 n m %PDF-1.3 % Patients with InterStim SureScan MRI leads only. He or she also provides advice on non-routine MR procedures. 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. 0000012562 00000 n How sacral nerve stimulation neuromodulation works. Under certain conditions. For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronics website at www.medtronic.com. Get the details on specific MRI compatibility for neuromodulation therapies. 0000028899 00000 n 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. 2013;100:959968. 756 129 MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. 0000027823 00000 n Actual results may differ materially from anticipated results. 0000010551 00000 n This therapy is not intended for patients with a urinary blockage. Save my name, email, and website in this browser for the next time I comment. endobj 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. 0000008350 00000 n 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. Patton V, Wiklendt L, Arkwright JW, Lubowski DZ, Dinning PG. 0000025529 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. 0000007795 00000 n That said, you have to ask yourself, are you a patient? 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: Update my browser now. j Update my browser now. 0000007197 00000 n Although many patients may benefit from the use of these treatments, results may vary. If you arent, you might as well find a urologist to help you out. Less than NBV132955H ? 0000006231 00000 n 0000014881 00000 n The Interstim system contains the aforementioned smart programmer, as well as a subcutaneous pulse generator (SPG) threaded through the S3 neural foramen. These components are well depicted on a standard radiograph. 0000010106 00000 n 0000023177 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. The InterStim II system is the only recharge-free, long-termSNM system that lets you get full-body* MRI scans. If you continue, you may go to a site run by someone else. 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. Medtronic 3058 Interstim II Neurostimulator for Bladder and Bowel Control. 427 20 With an updated browser, you will have a better Medtronic website experience. Questions and Answers in MRI - MRI Questions & Answers; MR imaging . 0000000016 00000 n 0000018245 00000 n However, it is important to consider the risk posed by your specific MRI scan parameters. Patients with InterStim MRI Leads only. 0000014674 00000 n xUMHTQ=gS?X J"!sR$$JQH]"(AAPHm@D1DE6y|#Asw;J 0000001914 00000 n How sacral nerve stimulation neuromodulation works. 0000007625 00000 n 0000027856 00000 n Br J Surg. These instructions do not apply to other implantable products, or other devices, products, or items. 0000005583 00000 n 0000023686 00000 n The manufacturers sterilize the products after they are packaged and it lasts so many years. 0000011527 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. neurostimulator will provide stimulation at programmed settings before requiring recharge). Search by model name, product name, or device type. 2013;100:959968. JbN}&Kt]FV~Uj_JK p a4! :}\ UxIM#ufX'z4WcHqFtEmXO0Su_[q/]&SZhz19>uK$V4} 1 kG,M^jaRv,gIvO& +x4pU.Vw 33/Ax/M>s["-89@ S$}D l~v626Zr 6o2ulSs?z=^!e/(k&zbxgn-p]o`vl@mv9670>=/o.HU}d~z6X{icp{y X]_ 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. Home 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. Magnetic Resonance Imaging (MRI) Guidelines for the Axonics System. However, the safety of MRI of other body regions in InterStim II patients remains uncertain. - (06:31), A video of how the InterStim II system electrically stimulates the sacral nerve for bladder control therapy. 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. 0000010287 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. REFERENCE
medtronic bladder stimulator mri safety 3058