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The Interstim II system may be suitable for most people because it's simple, convenient and lower maintenance.3. 0000013304 00000 n
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B2QPHbD (lT If you arent, you might as well find a urologist to help you out. 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.
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He or she works closely with the MR medical director and MR safety officer. %PDF-1.5
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MRI mode is easy for patients to independently activate or deactivate on the smart programmer. See approved labeling for details. Some of these interactions, especially heating, are potentially hazardous and can lead to serious or permanent patient injury. Implanted pulse generators were examined before and after MRI procedures.
However, several studies have shown no serious adverse outcomes. 0000016706 00000 n
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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). Aside from the aforementioned medical conditions, there is no shortage of people with urinary tract infections (UTIs).
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It is also about being aware of the proper way to conduct your exams and to ensure the safety of everyone involved. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 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. b Power-on-reset (POR) turns OFF stimulation by resetting the amplitude to 0.0 V and all electrodes to OFF. 0000006684 00000 n
Serial numbers ineligible for MRI scans (Model 3023 Neurostimulator only). That said, you have to ask yourself, are you a patient? However, further studies should be performed to determine the safety of MRI in other body regions in InterStim II patients. "This is not your grandmother's therapy.
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Some of these interactions, especially heating, are potentially hazardous and can lead to serious or permanent patient injury. "; 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:"?? MRI of the hand can be safely carried out with the Medtronic Interstim II device. 0000007038 00000 n
Regulatory Statements 2. 0000012610 00000 n
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For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronics website at www.medtronic.com. +yLKxN5F`W82r 0000012562 00000 n
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This includes a new B1+rms technology for 1.5Tesla scans, and an updated label that adds more flexibility to clinicians practices. The following information describes the potential interactions and control measures that should be taken to minimize the risks from these interactions.
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. xref
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MR safety expert is a person who is responsible for developing a local and safe MR safety framework.
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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. Important Safety Information, Medtronic Bladder Control Therapy delivered by the InterStim system, Medtronic Bladder Control Therapy delivered by the NURO system. 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). ?? Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Br J Surg.
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MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. 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. 0000028899 00000 n
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4.2. Learn how to turn the InterStim neurostimulator on and off with a Interstim iCon programmer.If you've tried other treatments but are still suffering from bla. 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.
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InterStim systems are the standard of care in advanced therapy options, and the most personalized system, to deliver sacral neuromodulation (SNM) therapy.
There have been few studies evaluating the risk of MRI in patients with this implant. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu website. 0000011083 00000 n
When the battery is depleted, the neurostimulator must be replaced. 1-(800)-723-4636 (Tachy) 1-(800)-505-4636 (Brady) International Technical Centers. 0000025647 00000 n
The Subcutaneous Electro-optical Crystal (SEC) has an electro-optical crystal that changes refractive indexes depending on the applied E-field.
The effect of sacral nerve stimulation on distal colonic motility in patients with fecal incontinence.
Home 0000004467 00000 n
The Interstim II device can be safely scanned at 1.5 T. 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. 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: ? 427 0 obj
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This small electro-optical device is not only a cool-looking device, but it does not affect the quality of your MRI images. This therapy is not intended for patients with pacemakers or implantable defibrillators, patients prone to excessive bleeding, patients with nerve damage that could impact either percutaneous tibial nerve or pelvic floor function, or on patients who are pregnant or planning pregnancy. xUMHTQ=gS?X J"!sR$$JQH]"(AAPHm@D1DE6y|#Asw;J
1.5T and 3T head coil MRI scans. Value in Health. It is possible that some of the products on the other site are not approved in your region or country. }$Y? "Countless people suffer from symptoms of bladder and bowel control conditions and thanks to significant recent technology advancements, SNM therapy is becoming a more popular option for patients," said Jannah H. Thompson, M.D., FPMRS, president of the Society of Women in Urology, and urologist at Urologic Consultants in Grand Rapids, Michigan. 0000016018 00000 n
With an updated browser, you will have a better Medtronic website experience. Y{p._(u[(|{-[=Wbx7TJCvSVvjiTB.|Ug`~w|#U5IkGYdh38Y. %%EOF
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Medtronic 3058 Interstim II Neurostimulator for Bladder and Bowel Control. 0000008924 00000 n
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These instructions do not apply to other implantable products, or other devices, products, or items. 0000014881 00000 n
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Contact your pain specialist to: See if you can safely undergo the type of MRI scan prescribed. 0000002333 00000 n
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Proprietary Overdrive battery technology that offers more than 15 years of battery life with regular recharging once a month, and the smallest, most powerful rechargeable SNM device on the market.
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This site is Exclusively Sponsored by BRACCO. hVmO8+j-oVH%v!Rno"dR/6M]q&PeY3gI"C%L)|"=9}Hp9>.H/)")KK0 AI>sOX$fEF\E\y
[> User Manual User Manual of 32 Navigation menu Upload a User Manual Wiki Guide Info User Manual Discussion / Help 0000013017 00000 n
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