World Population Prospects: The 2010 Revision, CD-ROM Edition.3Whitehead WE, Borrud L, Goode PS, et al. 0000005846 00000 n 0000018707 00000 n 0000010041 00000 n 349 0 obj <>stream 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). ' a9.aacz3CSoTz)_%v Considering that the InterStim is a ubiquitous presence in the bladder department, MRI safety is a must. <<8176020B0CB4AE4A9F0BF88D5F2A90DE>]/Prev 621018>> 0000006609 00000 n (8^T?Z$$0r @J9z6{,RLZtR!zbh*8 l2azr&_4=OG$Vkwy?5 P&Dg*[@K6WrqFKe]3 0000008397 00000 n igXOs!i']}E]Zxu#udHK}}{wMW~ia>=ekO zw,a_MfT\R "}con}l%BU?8>`MO{zcIRv2P,k{fXY0p0iX}Tk([orZjZEsh)v0:oHcg[_3/BX\>_7#-nLo.bpoUu~vwX"h 1Pc=r"5(K^4I@@G'AE*p N 756 0 obj 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. 0000006184 00000 n 0000007197 00000 n The Interstim II device can be safely scanned at 1.5 T. However, to safely achieve this feat, it is important to choose a suitable coil, use a corresponding hand coil, and position the patient in a way that minimizes the likelihood of heating. 1.5T and 3T head coil MRI scans. "Countless people suffer from symptoms of bladder and bowel control conditions and thanks to significant recent technology advancements, SNM therapy is becoming a more popular option for patients," said Jannah H. Thompson, M.D., FPMRS, president of the Society of Women in Urology, and urologist at Urologic Consultants in Grand Rapids, Michigan. 0000005584 00000 n 0000005042 00000 n 0000008350 00000 n Many patients with OAB or retention have poor or reduced quality of life because of their symptoms. 0000010503 00000 n Sacral Neuromodulation Systems 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. 0000006938 00000 n He or she works closely with the MR medical director and MR safety officer. 2. %PDF-1.3 % The Axonics Sacral Neuromodulation (SNM) System is a sacral nerve stimulation (SNS) system that is intended to treat urinary retention and the symptoms of overactive bladder. ?? Aside from the aforementioned medical conditions, there is no shortage of people with urinary tract infections (UTIs). 0000000016 00000 n 0000018197 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, - 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. "; 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:"?? The neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. 0000014402 00000 n 0000011240 00000 n endstream endobj 307 0 obj <>stream 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 recharge-free InterStim neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. Specifically, these guidelines expand the range of MRI scan parameters that clinicians can use, allowing them to offer patients with InterStim devices a wider array of MRI procedures. 0000024733 00000 n Medtronic 3058 Interstim II Neurostimulator for Bladder and Bowel Control. Value in Health. b Power-on-reset (POR) turns OFF stimulation by resetting the amplitude to 0.0 V and all electrodes to OFF. 0000007430 00000 n Unintended Stimulation MRI may cause unintended stimulation from the implant. Patients with InterStim MRI Leads only. InterStim II. 0000005535 00000 n 0000006231 00000 n +1 (305) 500-9328, - New InterStim X system provides 10 to 15 years of battery life without the need to recharge, - Medtronic bladder and bowel control portfolio offers the most personalized options to fit patient lifestyles, https://www.medtronic.com/us-en/index.html?intcmp=mdt_com_country_selector_dropdown_atlasr22016, Electromagnetic Compatibility Guide for Cardiac Devices, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers. 0000009993 00000 n Safety and effectiveness have not been established for pregnancy and delivery; patients under the age of 16; or for patients with neurological disease origins. 0 Sacral Neuromodulation Systems . neurostimulator will provide stimulation at programmed settings before requiring recharge). 0000004372 00000 n 0000008924 00000 n 0000065437 00000 n 0000013304 00000 n 0000008679 00000 n How sacral nerve stimulation neuromodulation works. It uses an implanted stimulator to deliver electrical pulses through a lead wire to electrodes located near the sacral nerve. 0000001682 00000 n Br J Surg. - (06:31), A video of how the InterStim II system electrically stimulates the sacral nerve for bladder control therapy. 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. 2003 May;20(6):327-336.2United Nations, Department of Economic and Social Affairs, Population Division (2011). 0000016706 00000 n 0000004494 00000 n InterStim II Model 3058 Neurostimulator Table 1. 0000008051 00000 n ?? 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. 0000009645 00000 n Medtronic Interstim 3058 MRI Safety MRI of the hand MRI of the hand can be safely carried out with the Medtronic Interstim II device. The implanted InterStim II system electrically stimulates the sacral nerve, which is thought to normalize neural communication between the bladder and brainand between the bowel and brain.1,2, Medtronic Bladder Control Therapy 0000014136 00000 n Pelvic floor disorders network. 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 The Global Unique Device Identification Database (GUDID) contains key device identification information submitted to the FDA about medical devices that have Unique Device Identifiers (UDI). 0000008727 00000 n 0000000696 00000 n 0000013358 00000 n 0000005583 00000 n 427 20 Update my browser now. 0000023177 00000 n "As we celebrate 25 years of InterStim this year, we're bullish about our next chapter in patient-focused therapy innovation. United States Census Bureau Web site. MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. 0000014238 00000 n 0000023883 00000 n With an updated browser, you will have a better Medtronic website experience. 0000028899 00000 n InterStim II. 1.5T and 3T upper and lower extremity MRI scans. 0000041486 00000 n It is important to understand that ferromagnetic metals and metallic implants can be harmful if they move in the flight path of the MR scanner. The latest InterStim is a small, discreet device, making it a safe option for many. Medtronic Manuals: Region Manual Library Instructions for use and product manuals for healthcare professionals Please select your region. Products Historically, patients with implantable SNM devices have been contraindicated for MRI. However, it is important to consider the risk posed by your specific MRI scan parameters. Both devices are used in the treatment of overactive bladder (OAB), chronic fecal incontinence (FI), and non-obstructive urinary retention. +yLKxN5F`W82r 4.2. Actual results may differ materially from anticipated results. 2M XF"EEN"cL D3 0000010222 00000 n The only products we caution customers about are ones that are absorbable or drug coated. 0000008003 00000 n 0000016760 00000 n endobj 0000003363 00000 n 0000008625 00000 n MRI of the hand can be safely carried out with the Medtronic Interstim II device. These therapies are not for everyone. 0000016458 00000 n The new guidelines add to Medtronics existing MRI label, which includes a comprehensive MRI Safety Guidance. It is safe and effective. 0000027688 00000 n %PDF-1.5 % "; 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. "; 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; mso-no-proof:yes;} .MsoChpDefault {mso-style-type:export-only; mso-default-props:yes; font-size:10.0pt; mso-ansi-font-size:10.0pt; mso-bidi-font-size:10.0pt; font-family:Cambria; mso-ascii-font-family:Cambria; mso-ascii-theme-font:minor-latin; mso-fareast-font-family:"?? 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