medtronic bladder stimulator mri safety 3058

0000008245 00000 n Persistence and adherence of medications for chronic overactive bladder/urinary incontinence in the California Medicaid Program. Medicare and many other private insurance companies cover Medtronic Bladder Control Therapy. 0000010275 00000 n For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu website. We are Medtronic. Update my browser now. m @J9z6{,RLZtR!zbh*8 l2azr&_4=OG$Vkwy?5 P&Dg*[@K6WrqFKe]3 0000005846 00000 n 0000000016 00000 n 0000006609 00000 n Spinal Cord Stimulation, SureScan MRI Version, Medtronic, Inc. The effect of sacral nerve stimulation on distal colonic motility in patients with fecal incontinence. 0000006555 00000 n %%EOF 0000009089 00000 n 0000005225 00000 n 0000017618 00000 n startxref 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 Br J Surg. 2009;15(9):728-740. Medtronic.com Contact Medtronic Terms of Use Privacy Statement Patient Implant Information Previous Versions of Manuals 2023 Medtronic 0000009883 00000 n 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. 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. 0000005583 00000 n 0000005584 00000 n Serial numbers ineligible for MRI scans (Model 3023 Neurostimulator only). ", "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. 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. 0000041486 00000 n Less information (see less). 0000014674 00000 n 427 20 {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 Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, Recharge-free neurostimulator for bladder and bowel control, 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, 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, Allows full-body MRI scans for patients who need them*, InterStim SureScan MRI lead model 978B1. Between NBV133037H and NBV133063H ? 0000014136 00000 n 0000005535 00000 n 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. 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. 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. Available at: https://www.census.gov/quickfacts/table/ PST045215/00. United States Census Bureau Web site. Contact Medtronic at the appropriate address or phone number listed at the back of this manual if you have any questions. It is safe and effective. Safety and effectiveness have not been established for pregnancy and delivery; patients under the age of 16; or for patients with neurological disease origins. You must demonstrate an appropriate response to the evaluation to be a candidate. 349 0 obj <>stream MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. Both devices are used in the treatment of overactive bladder (OAB), chronic fecal incontinence (FI), and non-obstructive urinary retention. However, several studies have shown no serious adverse outcomes. These treatments are prescribed by your doctor. Products MRI of the hand can be safely carried out with the Medtronic Interstim II device. These instructions do not apply to other implantable products, or other devices, products, or items. 0000018959 00000 n 0000009645 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. 0000018493 00000 n 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. 0000010503 00000 n Medtronic Manuals: Region Manual Library Instructions for use and product manuals for healthcare professionals Please select your region. Implanted pulse generators were examined before and after MRI procedures. xref ?? 0000005793 00000 n 0000010041 00000 n hb```b``^d(31 PCAed a2(m``_XA -cMt8{}*[e%A*AN)O0!!6FIIeAaRE#,XMtabX;'1wjg t7eD,zorsaR; ;@xR+ The powerful magnetic field of the MR system can also attract these metals, resulting in danger to people inside the room. It uses an implanted stimulator to deliver electrical pulses through a lead wire to electrodes located near the sacral nerve. 0000010106 00000 n 0000004887 00000 n Many patients with OAB or retention have poor or reduced quality of life because of their symptoms. +yLKxN5F`W82r The neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. Some of these interactions, especially heating, are potentially hazardous and can lead to serious or permanent patient injury. 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, - 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), - Model 3058 and eligible Model 3023 Neurostimulators: Turn the neurostimulator, - Eligible Model 3023 Neurostimulators only: Disable the magnet switch, Scanning under different conditions may result in severe patient injury or device. 756 0 obj These components are well depicted on a standard radiograph. 0000008727 00000 n The Subcutaneous Electro-optical Crystal (SEC) has an electro-optical crystal that changes refractive indexes depending on the applied E-field. See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. 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). startxref MRI-safety expert performed a patients MRI, MRI guidelines expand the range of scan parameters, Kiaraakitty Before Surgery Plastic Surgery, Net Worth. neurostimulator will provide stimulation at programmed settings before requiring recharge). 0000006684 00000 n 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 . If you are a doctor, you should be familiar with MRI safety guidelines. endstream endobj 302 0 obj <> endobj 303 0 obj <> endobj 304 0 obj <>stream 1.5T and 3T head coil MRI scans. SureScan technology that enables full body 1.5T and 3T MRI scans under certain conditions and does not require impedance checks. However, if the conditions for safe MRI are 2. Adverse events are typically temporary, and include mild pain, minor inflammation and bleeding near treatment site. 0000023686 00000 n The neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. endstream endobj 307 0 obj <>stream Under certain conditions. This is important, as there are some very serious consequences if you are not aware of the right procedures to follow. 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. 0000065437 00000 n ", More than 37 million adults in the United States almost one in six suffer from overactive bladder (OAB),1,2 and nearly 18 million Americans about one in 12 are living with fecal incontinence.3,4 Many sufferers limit their lives socially, professionally, and personally.5 However, as many as 45% who suffer from symptoms do not seek treatment and as many as seven in 10 stop using medications within six months due to intolerable side effects or unsatisfying results.6,7,8. 0000008350 00000 n However, it is important to consider the risk posed by your specific MRI scan parameters. With an updated browser, you will have a better Medtronic website experience. These updates also allow for a shorter waiting time between MRI scans. Gastroenterology. 2005;32:1118. hVmO8+j-oVH%v!Rno"dR/6M]q&PeY3gI"C%L)|"=9}Hp9>.H/)")KK0 AI>sOX$fEF\E\y [> Rh)b#0a(Z)#!H Bb*acH@L Q 9 , p043/aeSe3JEANr3>-u8wFXGp. 427 0 obj <> endobj 0000000696 00000 n InterStim II. hbbd```b``^"w L 5(09"z@d)6yd&` e:S&F=`iE <> Although many patients may benefit from the use of these treatments, results may vary. POR can occur when there is a temporary fluctuation in battery voltage (eg . Patients With an updated browser, you will have a better Medtronic website experience. It is also about being aware of the proper way to conduct your exams and to ensure the safety of everyone involved. hb```f``:2AX, N qx|lPl!X42p)q9s%n@VMtCTHzOw]o^Z)jhUos'd/m$-jcaVpM;;;::%\ 02," @ANNbb@, ~k]hz$Mp 0000023883 00000 n 2 InterStim Micro treats patients with overactive bladder, fecal incontinence, and non-obstructive urinary retention by delivering SNM therapy. MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. 0 The new guidelines add to Medtronics existing MRI label, which includes a comprehensive MRI Safety Guidance. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. 0000013017 00000 n 0000018197 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. 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. 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). 0000009598 00000 n 0000007383 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: 0000018809 00000 n b Power-on-reset (POR) turns OFF stimulation by resetting the amplitude to 0.0 V and all electrodes to OFF. The Interstim II system may be suitable for most people because it's simple, convenient and lower maintenance.3. The InterStim II system a recharge-free, long-term therapy that lets patients get full-body* MRI scans. Expiration dates have mostly to do with sterilization and not the integrity of the product. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. "; 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:"?? p;X``pe`.)N]KA@!0834X@wP t(p 4qgp)h` j{ About MedtronicBold thinking. Important Safety Information, Medtronic Bladder Control Therapy delivered by the InterStim system, Medtronic Bladder Control Therapy delivered by the NURO system. 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). 0000018547 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 . Methods. 0000027823 00000 n The following information describes the potential interactions and control measures that should be taken to minimize the risks from these interactions. The Interstim system contains the aforementioned smart programmer, as well as a subcutaneous pulse generator (SPG) threaded through the S3 neural foramen. 0000011527 00000 n Home Bolder actions. Tell the physician who prescribed your MRI scan that you have an implanted neurostimulation system. nmVe:D\YC]R Ab Z Urol Clin North Am. 0000004372 00000 n Several precautions should be taken, including selecting the appropriate coil and positioning the patient outside the MRI scanner room. 0000010323 00000 n Aside from the aforementioned medical conditions, there is no shortage of people with urinary tract infections (UTIs). This includes a new B1+rms technology for 1.5Tesla scans, and an updated label that adds more flexibility to clinicians practices. 0000016814 00000 n 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'[. De Wachter S. et al New Technologies and Applications in Sacral Neuromodulation: An Update Adv Ther 37, 637-643 (2020). . 0000015308 00000 n The clinician uses the Clinician app to . REFERENCE