0000009912 00000 n Value in Health. If you have an implanted neurostimulator and are going to undergo an MRI scan, you should take the following steps: 1. 0000007038 00000 n . 0000010503 00000 n 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. The following information describes the potential interactions and control measures that should be taken to minimize the risks from these interactions. 0000013460 00000 n endstream endobj 307 0 obj <>stream ", "We're on a mission to expand access to proven nerve stimulation therapies through technology advancements like InterStim X, InterStim Micro, SureScan MRI technology and the smart programmer, by offering patients personalized therapy options and by reaching them through direct-to-consumer marketing," said Mira Sahney, president of the Pelvic Health business, which is part of the Neuroscience Portfolio at Medtronic. 0000009137 00000 n Manuals can be viewed using a current version of any major internet browser. 0000017228 00000 n 0000009182 00000 n These updates also allow for a shorter waiting time between MRI scans. "As we celebrate 25 years of InterStim this year, we're bullish about our next chapter in patient-focused therapy innovation. xref hbbd```b``^"w L 5(09"z@d)6yd&` e:S&F=`iE 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: 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. 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. The Interstim II system may be suitable for most people because it's simple, convenient and lower maintenance.3. 0000023883 00000 n [UeK[Xe;vmy65R$yFi You must demonstrate an appropriate response to the evaluation to be a candidate. Adverse events are typically temporary, and include mild pain, minor inflammation and bleeding near treatment site. Current Medical Research and Opinion. MRI-safety expert performed a patients MRI, MRI guidelines expand the range of scan parameters, Kiaraakitty Before Surgery Plastic Surgery, Net Worth. 0000009993 00000 n If you continue, you may go to a site run by someone else. (8^T?Z$$0r This small device will improve patient satisfaction and reduce hospital readmissions. The Medtronic InterStim II Model 3058 Neurostimulator is used with a lead and the Medtronic InterStim Model 3023 Neurostimulator is used with a lead and an . 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: ? Medtronic Manuals: Region Manual Library Instructions for use and product manuals for healthcare professionals Please select your region. 0000010222 00000 n Shipping, operating, and power-on-reset (POR) values for the Medtronic InterStim II Model 3058 Neurostimulator a. a All values are approximate. Considering that the InterStim is a ubiquitous presence in the bladder department, MRI safety is a must. 0000008727 00000 n aiip ,@+er(Na[SI]$H-Gje*E q9L-k#:yDY$81*vw*h 0000014136 00000 n In fact, many of them might be considering the InterStim in the near future. 0000016760 00000 n Important note: Each device ind. Medtronic InterStim 3058 MRI safety is not just about making sure that you are using the right equipment. Contact Medtronic at the appropriate address or phone number listed at the back of this manual if you have any questions. These instructions do not apply to other implantable products, or other devices, products, or items. 0000007430 00000 n hb```f``:2AX, N qx|lPl!X42p)q9s%n@VMtCTHzOw]o^Z)jhUos'd/m$-jcaVpM;;;::%\ 02," @ANNbb@, ~k]hz$Mp 0000003266 00000 n However, several studies have shown no serious adverse outcomes. 0000002333 00000 n 0000008924 00000 n 0000011527 00000 n 0000018245 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. ?? 0000008397 00000 n InterStim II. 0000013412 00000 n World J Urol. hb```b``^d(31 PCAed a2(m``_XA -cMt8{}*[e%A*AN)O0!!6FIIeAaRE#,XMtabX;'1wjg t7eD,zorsaR; ;@xR+ 0000011192 00000 n 0 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. Several precautions should be taken, including selecting the appropriate coil and positioning the patient outside the MRI scanner room. 0000010323 00000 n 0000025277 00000 n 0000017570 00000 n About MedtronicBold thinking. MRI, inform the MRI technologist immediately and then contact your doctor. 0000012610 00000 n 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 . 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. 0000023719 00000 n This manual provides information for use in estimating battery longevity (the number of months or years that the These treatments are prescribed by your doctor. 0000026803 00000 n 0000004995 00000 n You cannot have diathermy (deep heat treatment from electromagnetic energy) if you have an InterStim device. It uses an implanted stimulator to deliver electrical pulses through a lead wire to electrodes located near the sacral nerve. Urol Clin North Am. 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. 5Z\&l:|iXeMt+Z5|L| 1v 3tT#`K?FWrS8% <> 0000013358 00000 n REFERENCE