Home Expiration dates have mostly to do with sterilization and not the integrity of the product. aiip ,@+er(Na[SI]$H-Gje*E q9L-k#:yDY$81*vw*h However, it is important to consider the risk posed by your specific MRI scan parameters. 0000013304 00000 n 0000008003 00000 n Contact your pain specialist to: See if you can safely undergo the type of MRI scan prescribed. 0000010599 00000 n 9>sa6 ~Ay@Z/l^/!6pLb+{Mk 0000006609 00000 n {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 2013;100:959968. 0000016410 00000 n Urol Clin North Am. Less information (see less). 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 . 884 0 obj 0000028229 00000 n Not for human use in the US. ?? MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. 0000017893 00000 n 301 0 obj <> endobj The Interstim system contains the aforementioned smart programmer, as well as a subcutaneous pulse generator (SPG) threaded through the S3 neural foramen. "As we celebrate 25 years of InterStim this year, we're bullish about our next chapter in patient-focused therapy innovation. 0000016018 00000 n Impact of overactive bladder on women in the United States: results of anational survey. Bolder actions. 0000004372 00000 n 0000006184 00000 n If you have an implanted neurostimulator and are going to undergo an MRI scan, you should take the following steps: 1. 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). Sacral Neuromodulation Systems <> However, several studies have shown no serious adverse outcomes. <<8176020B0CB4AE4A9F0BF88D5F2A90DE>]/Prev 621018>> 0000000016 00000 n Some of these interactions, especially heating, are potentially hazardous and can lead to serious or permanent patient injury. 0000006231 00000 n For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu website. 0000006985 00000 n Home 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). Patients 0000009993 00000 n 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. 0000023719 00000 n Shipping, operating, and power-on-reset (POR) values for the Medtronic InterStim II Model 3058 Neurostimulator a. a All values are approximate. 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. 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. 0000025647 00000 n However, the safety of MRI of other body regions in InterStim II patients remains uncertain. 0000009137 00000 n MRI, inform the MRI technologist immediately and then contact your doctor. However, if the conditions for safe MRI are Update my browser now. Persistence and adherence of medications for chronic overactive bladder/urinary incontinence in the California Medicaid Program. 0000017618 00000 n Current Medical Research and Opinion. . 0000004887 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. Regulatory Statements 2. 0000007625 00000 n %%EOF Ll2@108 0000007038 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. 9850 NW 41st Street, Suite 450, Doral, FL 33178 4.2. 2007;23:65-76.6Leede Research, "Views on OAB: A Study for the National Association of Continence." If you are a doctor, you should be familiar with MRI safety guidelines. Prevalence and burden of overactive bladder in the United States. Patton V, Wiklendt L, Arkwright JW, Lubowski DZ, Dinning PG. 2005;32:1118. - (06:31), A video of how the InterStim II system electrically stimulates the sacral nerve for bladder control therapy. Products 0000009089 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. 0 InterStim systems are the standard of care in advanced therapy options, and the most personalized system, to deliver sacral neuromodulation (SNM) therapy. 0000019081 00000 n "; 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:"?? 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. MRI mode is easy for patients to independently activate or deactivate on the smart programmer. Accessed July 19, 2016.5Dmochowski RR, Newman DK. 0000005535 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. Healthcare Professionals InterStim systems are the standard of care in advanced therapy options . 0000014626 00000 n Your doctor should discuss all potential benefits and risks with you. He or she works closely with the MR medical director and MR safety officer. The neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. Important Safety Information, Medtronic Bladder Control Therapy delivered by the InterStim system, Medtronic Bladder Control Therapy delivered by the NURO system. The latest InterStim is a small, discreet device, making it a safe option for many. 0 In everything we do, we are engineering the extraordinary. Several precautions should be taken, including selecting the appropriate coil and positioning the patient outside the MRI scanner room. This small electro-optical device is not only a cool-looking device, but it does not affect the quality of your MRI images. Value in Health. 0000011736 00000 n MR safety expert is a person who is responsible for developing a local and safe MR safety framework. 0000004995 00000 n 0000013358 00000 n In fact, many of them might be considering the InterStim in the near future. Medtronic Operational Headquarters 710 Medtronic Parkway Minneapolis, MN 55432-5640 USA, 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. About MedtronicBold thinking. 0000013017 00000 n 1.5T and 3T upper and lower extremity MRI scans. All patients had their parameters recorded; then the IPGs were put to "nominal" status. trailer Patients with InterStim MRI Leads only. %%EOF The powerful magnetic field of the MR system can also attract these metals, resulting in danger to people inside the room. 0000018055 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. ", "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. 0000006938 00000 n Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced it received approval from the U.S. Food and Drug Administration (FDA) for InterStim X the next generation DUBLIN, Feb. 22, 2022 /PRNewswire/ --Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced it received approval from the U.S. Food and Drug Administration (FDA) for InterStim X the next generation of the InterStim portfolio's recharge-free device and it is available immediately. 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