0000004713 00000 n The Interstim II system may be suitable for most people because it's simple, convenient and lower maintenance.3. "; 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:"?? 0000004887 00000 n nmVe:D\YC]R Ab Z The new labeling also decreases wait time from 60 minutes to 5 minutes for maximum duration scans (30 minutes). He or she also provides advice on non-routine MR procedures. Products 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). World Population Prospects: The 2010 Revision, CD-ROM Edition.3Whitehead WE, Borrud L, Goode PS, et al. 0000023883 00000 n Search for downloadable product manuals by product name or model number. [UeK[Xe;vmy65R$yFi 0000006184 00000 n The Interstim system contains the aforementioned smart programmer, as well as a subcutaneous pulse generator (SPG) threaded through the S3 neural foramen. <<643BDC4F02F463BA264A9A2366C35000>]>> Value in Health. b Power-on-reset (POR) turns OFF stimulation by resetting the amplitude to 0.0 V and all electrodes to OFF. ?? 0000008298 00000 n Save my name, email, and website in this browser for the next time I comment. In everything we do, we are engineering the extraordinary. Important note: Each device ind. Current Medical Research and Opinion. In fact, many of them might be considering the InterStim in the near future. 0000005042 00000 n 0000065437 00000 n Information on this site should not be used as a substitute for talking with your doctor. 0000009830 00000 n Gastroenterology. 0000018493 00000 n MRI of the lumbar and pelvic regions with the Medtronic Interstim II (model 3058) stimulator has been shown to be safe. 0000012969 00000 n More information (see more) 0000009645 00000 n Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. The Subcutaneous Electro-optical Crystal (SEC) has an electro-optical crystal that changes refractive indexes depending on the applied E-field. 0000027856 00000 n Hg1}Y@d3}quQ D~+ For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronics website at www.medtronic.com. The FDA approved the long-lived, rechargeable, full-body MRI compatible Axonics r-SNM System in late 2019, with the first commercial sales occurring in November 2019 . ;zrz'm,E*|3;aB.v` qRy 0000004045 00000 n 0000009317 00000 n How sacral nerve stimulation neuromodulation works. ?? <> hVmO8+j-oVH%v!Rno"dR/6M]q&PeY3gI"C%L)|"=9}Hp9>.H/)")KK0 AI>sOX$fEF\E\y [> 0000014881 00000 n Patton V, Wiklendt L, Arkwright JW, Lubowski DZ, Dinning PG. Please talk to your doctor to decide whether these therapies are right for you. Aside from the aforementioned medical conditions, there is no shortage of people with urinary tract infections (UTIs). ?? Sacral Neuromodulation Systems United States Census Bureau Web site. However, several studies have shown no serious adverse outcomes. 0000000016 00000 n InterStim systems are the standard of care in advanced therapy options . 0000017893 00000 n Although many patients may benefit from the use of these treatments, results may vary. Treatments & Therapies Important Safety Information, Medtronic Bladder Control Therapy delivered by the InterStim system, Medtronic Bladder Control Therapy delivered by the NURO system. 0000016410 00000 n 0000011736 00000 n . ' a9.aacz3CSoTz)_%v Both devices are used in the treatment of overactive bladder (OAB), chronic fecal incontinence (FI), and non-obstructive urinary retention. 0000012562 00000 n 2005;8(4)495-505.8Yeaw J, Benner JS, Walt JG, Sian S, Smith DB, et al. HUMs6Wlo86;L,fzJTI4 i&p\}xX.@1Tn`}!a[z$WC@WH0)zK61xD"6Vqyu*^pJ3hAX638}Iv=M$ ZDp`2fK3F_E} J jV?hOS1Eg{y 0000023451 00000 n The InterStim II system is the only recharge-free, long-termSNM system that lets you get full-body* MRI scans. InterStim II. The neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. 427 20 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: endobj 0000008679 00000 n 0000027445 00000 n Medicare and many other private insurance companies cover Medtronic Bladder Control Therapy. 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. Your doctor should discuss all potential benefits and risks with you. 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. 0000018755 00000 n `ir8s]:FQpyibR-`,}8my) b&(bN (o|w o Your use of the other site is subject to the terms of use and privacy statement on that site. 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 Interstim II device can be safely scanned at 1.5 T. 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. If using an MRI SureScan device, see the MRI SureScan technical manual before performing an MRI. xref . MRI, inform the MRI technologist immediately and then contact your doctor. hb```f``:2AX, N qx|lPl!X42p)q9s%n@VMtCTHzOw]o^Z)jhUos'd/m$-jcaVpM;;;::%\ 02," @ANNbb@, ~k]hz$Mp Magnetic Resonance Imaging (MRI) Guidelines for the Axonics System. 4.2. Br J Surg. 0 Axonics SNM Systems are MRI conditionally safe for: 1.5T and 3T full-body MRI scans. 0000008003 00000 n Always talk with your doctor about diagnosis and treatment information. +yLKxN5F`W82r 0000009182 00000 n It's exciting to tell patients about the personalized, discreet, smart tech-enabled InterStim choices they now have for long-term relief. aiip ,@+er(Na[SI]$H-Gje*E q9L-k#:yDY$81*vw*h 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. 0000018959 00000 n Depuy Barrels-Product Line is now a Zimmer Biomet Product, Zimmer Austin-Moore Fenestrated Hip Implants, 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 smart programmer for clinicians, TYRX neuro absorbable antibacterial envelope, Experience urge incontinence or urgency-frequency, Experience urinary retention without an obstruction, Need another option if medication does not provide symptom relief and/or causes unpleasant side effects, Want an alternative to repeated injections, Have not demonstrated an appropriate response to the InterStim/therapy evaluation, Are unable to operate mobile devices (such as the smart programmer for the InterStim system), Are not appropriate candidates for surgery, Experience retention due to obstructions (such as BPH, cancer, or urethral stricture), Experience urge incontinence and/or passive incontinence, Need another option if medication that does not provide symptom relief and/or causes unpleasant side effects, Have issues using mobile devices (such as the smart programmer for the InterStim system). In order to ensure safety in MR facilities, all personnel involved must understand safety procedures and be willing to communicate with each other. Urol Clin North Am. 0000008924 00000 n MR safety expert is a person who is responsible for developing a local and safe MR safety framework. 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. There have been few studies evaluating the risk of MRI in patients with this implant. 0000124808 00000 n "This is not your grandmother's therapy. 0000011431 00000 n Exercise caution for patients with heart problems. endstream endobj 305 0 obj <>stream Less information (see less). 0000009993 00000 n 0000009458 00000 n 0000010041 00000 n 0000005793 00000 n 2. 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. 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. 0000006023 00000 n 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. These treatments are prescribed by your doctor. The powerful magnetic field of the MR system can also attract these metals, resulting in danger to people inside the room. 1-(800)-723-4636 (Tachy) 1-(800)-505-4636 (Brady) International Technical Centers. 1.5T and 3T upper and lower extremity MRI scans. However, further studies should be performed to determine the safety of MRI in other body regions in InterStim II patients. 0000018445 00000 n Search for downloadable product manuals by product name or model number. 0000005583 00000 n Contact Medtronic at the appropriate address or phone number listed at the back of this manual if you have any questions. 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. This therapy is not intended for patients with a urinary blockage. 0000016760 00000 n De Wachter S. et al New Technologies and Applications in Sacral Neuromodulation: An Update Adv Ther 37, 637-643 (2020). See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. 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: REFERENCE