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. 0000010106 00000 n <<8176020B0CB4AE4A9F0BF88D5F2A90DE>]/Prev 621018>> Axonics SNM Systems are MRI conditionally safe for: 1.5T and 3T full-body MRI scans. 0000003937 00000 n 0000012800 00000 n 0000008245 00000 n 0000041486 00000 n 0000009137 00000 n 0000010503 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. 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. 0000010041 00000 n }$Y? 0000018493 00000 n More information (see more) How sacral nerve stimulation neuromodulation works. Home {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 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. The neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. hb```b``^d(31 PCAed a2(m``_XA -cMt8{}*[e%A*AN)O0!!6FIIeAaRE#,XMtabX;'1wjg t7eD,zorsaR; ;@xR+ startxref 0000009598 00000 n 0000023020 00000 n Br J Surg. It's exciting to tell patients about the personalized, discreet, smart tech-enabled InterStim choices they now have for long-term relief. 0000001914 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. 0000005225 00000 n The following information describes the potential interactions and control measures that should be taken to minimize the risks from these interactions. 0000007038 00000 n SureScan technology that enables full body 1.5T and 3T MRI scans under certain conditions and does not require impedance checks. Patton V, Wiklendt L, Arkwright JW, Lubowski DZ, Dinning PG. 0000009182 00000 n Many patients with OAB or retention have poor or reduced quality of life because of their symptoms. 0000009993 00000 n InterStim II Model 3058 Neurostimulator Table 1. View MRI guidelines in the MRI Resource Library. 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. Learn the parameters of patient selection for bladder control and bowel control. 0000010323 00000 n 0000018959 00000 n 0000018245 00000 n 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 Contact Medtronic at the appropriate address or phone number listed at the back of this manual if you have any questions. 0000011527 00000 n 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. 0000023686 00000 n 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. With an updated browser, you will have a better Medtronic website experience. Contact Medtronic at the appropriate address or phone number listed at the back of this manual if you have any questions. 0000018547 00000 n ?? 0000065437 00000 n J Manag Care Pharm. Patients with InterStim MRI Leads only. Manuals can be viewed using a current version of any major internet browser. 0000015970 00000 n The new guidelines add to Medtronics existing MRI label, which includes a comprehensive MRI Safety Guidance. User Manual User Manual of 32 Navigation menu Upload a User Manual Wiki Guide Info User Manual Discussion / Help endstream endobj 302 0 obj <> endobj 303 0 obj <> endobj 304 0 obj <>stream 0000017228 00000 n The Interstim II device can be safely scanned at 1.5 T. endstream endobj 428 0 obj <. MRI of the hand can be safely carried out with the Medtronic Interstim II device. 0000027688 00000 n 0000000696 00000 n InterStim systems are the standard of care in advanced therapy options . Hg1}Y@d3}quQ D~+ Class 2 Device Recall InterStim (TM) System. However, further studies should be performed to determine the safety of MRI in other body regions in InterStim II patients. 0000017893 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). 0000008350 00000 n 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. 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]_ 0000013358 00000 n Ll2@108 756 0 obj xref See approved labeling for details. 0000009912 00000 n 0000016760 00000 n Products Between NBV133037H and NBV133063H ? For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu website. This therapy isappropriatefor bladder control patients who: This therapy isnot appropriatefor bladder control patients who: Many patients with chronic FI have poor or reduced quality of life because of their symptoms. hbbd```b``^"w L 5(09"z@d)6yd&` e:S&F=`iE 0000012562 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). "; 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. You must demonstrate an appropriate response to the evaluation to be a candidate. Pelvic floor disorders network. InterStim II. 0000024733 00000 n It is safe and effective. Impact of overactive bladder on women in the United States: results of anational survey. Patients with InterStim SureScan MRI leads only. p;X``pe`.)N]KA@!0834X@wP t(p 4qgp)h` j{ Expiration dates have mostly to do with sterilization and not the integrity of the product. 0000008397 00000 n MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. 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. With an updated browser, you will have a better Medtronic website experience. 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). 0000004372 00000 n Considering that the InterStim is a ubiquitous presence in the bladder department, MRI safety is a must. MRI of the lumbar and pelvic regions with the Medtronic Interstim II (model 3058) stimulator has been shown to be safe. Home 0000008298 00000 n 0000006985 00000 n 0000006657 00000 n 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). 2. United States Census Bureau Web site. 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: <> m Implanted pulse generators were examined before and after MRI procedures. 0000004448 00000 n 0000009883 00000 n 756 129 0000008625 00000 n The effect of sacral nerve stimulation on distal colonic motility in patients with fecal incontinence. Although many patients may benefit from the use of these treatments, results may vary. REFERENCE