medtronic bladder stimulator mri safety 3058

0000008924 00000 n 0000006609 00000 n Accessed July 19, 2016.5Dmochowski RR, Newman DK. 0000012014 00000 n 0000009317 00000 n Contact your pain specialist to: See if you can safely undergo the type of MRI scan prescribed. ?? Urol Clin North Am. . For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronics website at www.medtronic.com. %PDF-1.3 % The implanted InterStim II system electrically stimulates the sacral nerve, which is thought to normalise neural communication between the bladder and brainand between the bowel and brain.1,2, Medtronic Bladder Control Therapy 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. Less than NBV132955H ? 0000008003 00000 n Important note: Each device ind. 0000027823 00000 n ATTENTION: READ THE FULL LABELING FOR THIS INFORMATION BEFORE CONDUCTING AN MRI EXAMINATION IN A PATIENT WITH THIS DEVICE. 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'[. In August 2020, the FDA approved the InterStim Micro neurostimulator and InterStim SureScan MRI leads for the treatment of patients with bladder and bowl control conditions. Regulatory Statements 2. 4.2. However, if the conditions for safe MRI are World Population Prospects: The 2010 Revision, CD-ROM Edition.3Whitehead WE, Borrud L, Goode PS, et al. Urological In order to ensure safety in MR facilities, all personnel involved must understand safety procedures and be willing to communicate with each other. hb```f``:2AX, N qx|lPl!X42p)q9s%n@VMtCTHzOw]o^Z)jhUos'd/m$-jcaVpM;;;::%\ 02," @ANNbb@, ~k]hz$Mp If you continue, you may go to a site run by someone else. 0000007828 00000 n 0000009782 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. This contraindication was due to heating of the electrodes, which could damage neural tissue. 0000008298 00000 n 0000008350 00000 n The following information describes the potential interactions and control measures that should be taken to minimize the risks from these interactions. Br J Surg. Methods: Eight MRI examinations at 1.5Tesla were conducted in areas outside the pelvis on six patients with implanted sacral nerve stimulator (InterStim neurostimulator; Medtronic, Inc, Minneapolis, MN, USA). 1.5T and 3T head coil MRI scans. 0000009830 00000 n trailer 0000004448 00000 n Sacral Neuromodulation Systems 0000009883 00000 n More information (see more) 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. endstream endobj 307 0 obj <>stream The InterStim II system a recharge-free, long-term therapy that lets patients get full-body* MRI scans. 0000009137 00000 n 0000027856 00000 n 756 129 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: ? 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 . 1Stewart WF, et al. 0000018445 00000 n Your doctor should discuss all potential benefits and risks with you. 0000016308 00000 n You may choose to re-enter your serial number, or contact Medtronic at one of the numbers below: Information for Healthcare Providers US Technical Services Department. 0000014626 00000 n Healthcare Professionals 0000026803 00000 n The latest InterStim is a small, discreet device, making it a safe option for many. The InterStim II Model 3058 Neurostimulator is not rechargeable. 0000011240 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: - 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. Actual results may differ materially from anticipated results. The Interstim II device can be safely scanned at 1.5 T. Click OK to confirm you are a Healthcare Professional. Available at: https://www.census.gov/quickfacts/table/ PST045215/00. Questions and Answers in MRI - MRI Questions & Answers; MR imaging . Safety and effectiveness have not been established for pregnancy and delivery; patients under the age of 16; or for patients with neurological disease origins. "; 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. Bladder Control That said, you have to ask yourself, are you a patient? Learn the parameters of patient selection for bladder control and bowel control. Medtronic 3058 InterStim II User Manual InterStim Therapy Medtronic, Inc. InterStim II InterStim Therapy UserManual.wiki > Medtronic > 3058 User Manual > User Manual Contents 1. Now the only SNM system backed by 90+ clinical studies, 1,000+ clinical articles, 350,000 patients treated and 25 years of experience, also offers patients a decade or more of treatment with either the new recharge-free InterStim X device, or the rechargeable InterStim Micro device. 0000017618 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). 2009;137: 512-517.4United States Quick Facts. Unintended Stimulation MRI may cause unintended stimulation from the implant. 0000025647 00000 n 0000008679 00000 n 0000013412 00000 n 0000014881 00000 n Sacral Neuromodulation Systems Ll2@108 0000124808 00000 n xUMHTQ=gS?X J"!sR$$JQH]"(AAPHm@D1DE6y|#Asw;J Home Medicare and many other private insurance companies cover Medtronic Bladder Control Therapy. 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. 0000006231 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. Manuals can be viewed using a current version of any major internet browser. 0000004045 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. If you are a doctor, you should be familiar with MRI safety guidelines. 0000025277 00000 n 0000004995 00000 n Home This is important, as there are some very serious consequences if you are not aware of the right procedures to follow. 0000018707 00000 n 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. 0000005584 00000 n [UeK[Xe;vmy65R$yFi Update my browser now. 0000018547 00000 n United States Census Bureau Web site. 0000023177 00000 n The new labeling also decreases wait time from 60 minutes to 5 minutes for maximum duration scans (30 minutes). 0000005846 00000 n 0000009089 00000 n Central/Eastern Europe, Middle East & Africa, 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 SureScan MRI lead model 978B1. Methods. In everything we do, we are engineering the extraordinary. Current Medical Research and Opinion. 0000006753 00000 n MRI mode is easy for patients to independently activate or deactivate on the smart programmer. (8^T?Z$$0r xref These therapies are not for everyone. You must demonstrate an appropriate response to the evaluation to be a candidate. j If you have an implanted neurostimulator and are going to undergo an MRI scan, you should take the following steps: 1. Leng WW, Chancellor MB. Magnetic Resonance Imaging (MRI) Guidelines for the Axonics System. ;zrz'm,E*|3;aB.v` qRy +yLKxN5F`W82r endobj Contact Medtronic at the appropriate address or phone number listed at the back of this manual if you have any questions. 0000006501 00000 n Patients with InterStim SureScan MRI leads only. 2007;23:65-76.6Leede Research, "Views on OAB: A Study for the National Association of Continence." Update my browser now. 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