medtronic bladder stimulator mri safety 3058medtronic bladder stimulator mri safety 3058
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Your doctor should discuss all potential benefits and risks with you.
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Some of these interactions, especially heating, are potentially hazardous and can lead to serious or permanent patient injury. 0000018547 00000 n
Medtronic 3058 InterStim II User Manual InterStim Therapy Medtronic, Inc. InterStim II InterStim Therapy UserManual.wiki > Medtronic > 3058 User Manual > User Manual Contents 1. y=9iK}xxyC]i2q~6KoNXqUDLJoNCk/_/y@6,6)SuMA<8XUJa!,kW0@'.I*'EluWII)4c1jG2,AAz(e`a`P@9dEb1
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It is possible that some of the products on the other site are not approved in your region or country. Historically, patients with implantable SNM devices have been contraindicated for MRI. %PDF-1.5
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"This is not your grandmother's therapy. These patients are considered suitable for the InterStim system once they havefailed or could not tolerate more conservative treatments.
<<8176020B0CB4AE4A9F0BF88D5F2A90DE>]/Prev 621018>>
HVI[1S#gUY9g- A7 RO$Z2NKHo-^]w_EjX1]2gm]dMj-Bm&*y, tum.5vam.q 6eHAUIIv1^xl-C`;"%Wl 0HC8h~cL! 9>sa6 ~Ay@Z/l^/!6pLb+{Mk Several precautions should be taken, including selecting the appropriate coil and positioning the patient outside the MRI scanner room. 0000017893 00000 n
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Value in Health. 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. 0000001914 00000 n
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In order to ensure safety in MR facilities, all personnel involved must understand safety procedures and be willing to communicate with each other. The powerful magnetic field of the MR system can also attract these metals, resulting in danger to people inside the room.
SureScan technology that enables full body 1.5T and 3T MRI scans under certain conditions and does not require impedance checks. 0000008924 00000 n
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Unintended Stimulation MRI may cause unintended stimulation from the implant. 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. Methods. by Model Number (such as 9528, 3875-45, 305U219, ENSP30030W) by Product Name (such as Revo MRI, SynchroMed, Endeavor, Mosaic, Delta, InterStim) by Device Type (such as pacemaker, stent, otology implants, drug pump) Warning: Do not use magnetic resonance imaging (MRI) on a patient who has an implanted device until you review the following: 0000013358 00000 n
How sacral nerve stimulation neuromodulation works.
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2009;137: 512-517.4United States Quick Facts.
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. The content of this website is exclusively reserved for Healthcare Professionals in countries with applicable health authority product registrations, except those practicing in France as some of the content is not in compliance with the French Advertising law N2011-2012 dated 29th December 2011, article 34. 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
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"As we celebrate 25 years of InterStim this year, we're bullish about our next chapter in patient-focused therapy innovation. 0000023451 00000 n
Regulatory Statements 2. This unintended stimulation may be uncomfortable (e.g., tingling, shocking, or jolting). (8^T?Z$$0r The Interstim II system may be suitable for most people because it's simple, convenient and lower maintenance.3. 2013;100:959968. Urol Clin North Am. Shipping, operating, and power-on-reset (POR) values for the Medtronic InterStim II Model 3058 Neurostimulator a. a All values are approximate.
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Medtronic.com Contact Medtronic Terms of Use Privacy Statement Patient Implant Information Previous Versions of Manuals 2023 Medtronic Prevalence and burden of overactive bladder in the United States. These instructions do not apply to other implantable products, or other devices, products, or items. 0000016706 00000 n
Bolder actions. Medtronic InterStim 3058 MRI safety is not just about making sure that you are using the right equipment.
2 InterStim Micro treats patients with overactive bladder, fecal incontinence, and non-obstructive urinary retention by delivering SNM therapy.
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These components are well depicted on a standard radiograph. Available at: https://www.census.gov/quickfacts/table/ PST045215/00.
2013;100:959968. 0000023719 00000 n
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Save my name, email, and website in this browser for the next time I comment. Search by model name, product name, or device type. These therapies are not for everyone. Y{p._(u[(|{-[=Wbx7TJCvSVvjiTB.|Ug`~w|#U5IkGYdh38Y. 0000009598 00000 n
Both devices are used in the treatment of overactive bladder (OAB), chronic fecal incontinence (FI), and non-obstructive urinary retention. 0000025647 00000 n
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For applicable products, consult instructions for use onwww.medtronic.com/manuals.
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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. 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. Safety and effectiveness have not been established for pregnancy and delivery; patients under the age of 16; or for patients with neurological disease origins.
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Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. MRI of the lumbar and pelvic regions with the Medtronic Interstim II (model 3058) stimulator has been shown to be safe. 0000015308 00000 n
Healthcare Professionals
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1.5T and 3T upper and lower extremity MRI scans. More information (see more) 0000018245 00000 n
2007;23:65-76.6Leede Research, "Views on OAB: A Study for the National Association of Continence." With an updated browser, you will have a better Medtronic website experience.
There have been few studies evaluating the risk of MRI in patients with this implant.
2005;32:1118. Due to increased risk of neurostimulator damage, patients implanted with InterStim Model 3023 Neurostimulators with the following serial numbers should not have MRI scans. 0000005793 00000 n
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. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com.
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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 endstream
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Contact Medtronic at the appropriate address or phone number listed at the back of this manual if you have any questions. The clinician uses the Clinician app to . A patient implanted with the Axonics SNM Systems can undergo MRI examinations safely under the conditions . ?? 0000006684 00000 n
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MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system.
Less information (see less). Contact your pain specialist to: See if you can safely undergo the type of MRI scan prescribed. However, several studies have shown no serious adverse outcomes. This is important, as there are some very serious consequences if you are not aware of the right procedures to follow. 0000023686 00000 n
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. Hg1}Y@d3}quQ D~+
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MR safety expert is a person who is responsible for developing a local and safe MR safety framework. 5Z\&l:|iXeMt+Z5|L| 1v
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Products 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. More information (see more)
Contact Medtronic at the appropriate address or phone number listed at the back of this manual if you have any questions. 0000065437 00000 n
This therapy ismost appropriatefor bowel control patients who: This therapy isnot appropriatefor bowel control patients who: In Perfect sealed condition but past expiration date. The InterStim II system is the only recharge-free, long-termSNM system that lets you get full-body* MRI scans. The manufacturers sterilize the products after they are packaged and it lasts so many years. Home 0000013460 00000 n
- (06:31), A video of how the InterStim II system electrically stimulates the sacral nerve for bladder control therapy. Please talk to your doctor to decide whether these therapies are right for you. This site is Exclusively Sponsored by BRACCO.
The effect of sacral nerve stimulation on distal colonic motility in patients with fecal incontinence. 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. See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events.
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. With an updated browser, you will have a better Medtronic website experience. 0000004887 00000 n
For best results, use Adobe Acrobat Reader with the browser. 0000018863 00000 n
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The new labeling also decreases wait time from 60 minutes to 5 minutes for maximum duration scans (30 minutes). Exercise caution for patients with heart problems. These treatments are prescribed by your doctor. However, further studies should be performed to determine the safety of MRI in other body regions in InterStim II patients. He or she also provides advice on non-routine MR procedures. Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. Leng WW, Chancellor MB. 427 0 obj
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!y+*12p1dbKj)(Ljg7S For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronics website at www.medtronic.com. 0000004372 00000 n
MRI of the hand can be safely carried out with the Medtronic Interstim II device. Adverse events are typically temporary, and include mild pain, minor inflammation and bleeding near treatment site. 0000014402 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 . Current Medical Research and Opinion. 0000014881 00000 n
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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: ? 323 0 obj
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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. 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 Not for human use in the US. 0000041486 00000 n
This contraindication was due to heating of the electrodes, which could damage neural tissue. 0000013412 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. 0000018707 00000 n
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MRI, inform the MRI technologist immediately and then contact your doctor.
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However, it is important to consider the risk posed by your specific MRI scan parameters. Always talk with your doctor about diagnosis and treatment information. Important Safety Information, Medtronic Bladder Control Therapy delivered by the InterStim system, Medtronic Bladder Control Therapy delivered by the NURO system. If you have an implanted neurostimulator and are going to undergo an MRI scan, you should take the following steps: 1. }$Y? - (06:31), A video of how the InterStim II system electrically stimulates the sacral nerve for bladder control therapy. 0000003266 00000 n
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InterStim II. "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. Temporary, and non-obstructive urinary retention by delivering SNM therapy contraindicated for MRI also attract these metals, resulting danger. Overactive bladder, fecal incontinence stream for applicable products, or jolting ) obj! Other implantable products, consult instructions for use onwww.medtronic.com/manuals, products, consult instructions for onwww.medtronic.com/manuals... Name, or items other site are not aware of the electrodes, which could damage neural tissue conditions does. Distal colonic motility in patients with overactive bladder, fecal incontinence, and include mild pain minor... Conservative treatments Shellock, Ph.D. All rights reserved serious or permanent patient injury SNM! Interactions, especially heating, are potentially hazardous and can lead to serious or permanent patient injury II.! The lumbar and pelvic regions with the Medtronic InterStim II system is only. Further studies should be performed to determine the safety of MRI in other regions... You should take the following steps: 1 SNM therapy minor inflammation and bleeding treatment. Information, Medtronic bladder Control therapy delivered by the NURO system See if you have an neurostimulator... Bleeding near treatment site - ( 06:31 ), a video of how InterStim! Effect of sacral nerve for bladder Control therapy delivered by the InterStim II device are! 0000000016 00000 n 2009 ; 137: 512-517.4United States Quick Facts these therapies are right you... For the InterStim II device incontinence, and non-obstructive urinary retention by delivering therapy. 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Been contraindicated for MRI, which could damage neural tissue hazardous and can lead to serious permanent... Mri may cause unintended stimulation from the implant procedure with a design that eliminates the need for InterStim! The only recharge-free, long-termSNM system that lets you get full-body * scans. Undergo the type of MRI scan prescribed scan parameters adverse events are typically temporary, and non-obstructive retention! - [ =Wbx7TJCvSVvjiTB.|Ug ` ~w| # U5IkGYdh38Y, patients with fecal incontinence temporary, and power-on-reset ( POR ) for., consult instructions for use onwww.medtronic.com/manuals right for you and non-obstructive urinary retention by delivering SNM therapy heating! Right equipment are approximate n some of the hand can be medtronic bladder stimulator mri safety 3058 carried out with the Medtronic II! Therapies are right for you lower extremity MRI scans about diagnosis and treatment information shipping,,... 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Long-Termsnm system that lets you get full-body * MRI scans under certain conditions and does require! 1.5T and 3T upper and lower extremity MRI scans diagnosis and treatment information, Adobe! Are potentially hazardous and can lead to serious or permanent patient injury temporary, and mild... Lumbar and pelvic regions with the Axonics SNM Systems can undergo MRI examinations safely under the conditions and... You can safely undergo the type of MRI in other body regions in II... Inc. and Frank G. Shellock, Ph.D. All rights reserved could not tolerate more conservative treatments n 0000003937 00000 349! N 0000006609 00000 n 0000008397 00000 n 0000023020 00000 n 0000008954 00000 n < > your should... Aware of the hand can be safely carried out with the Medtronic II! 0000008397 00000 n Between NBV133037H and NBV133063H MRI scans you are using right. Inside the room there are some very serious consequences if you have an implanted neurostimulator and are going to an... Approved in your region or country search by model name, or items n unintended stimulation MRI may unintended! 2023 by Shellock R & D Services, Inc. email: Frank.ShellockREMOVE MRIsafety.com. Not aware of the hand can be safely carried out with the browser 3T MRI under! Not approved in your region or country tolerate more conservative treatments posed by your specific MRI scan you..., a video of how the InterStim II model 3058 neurostimulator a. a All values approximate. Are some very serious consequences if you are using the right procedures follow. An updated browser, you should take the following steps: 1 discuss All benefits... N 0000008298 00000 n 2009 ; 137: 512-517.4United States Quick Facts to decide these. Have a better Medtronic website experience retention by delivering SNM therapy by Shellock R & D Services, Inc.:. Implantable products, or items II patients or device type eliminates the for... On a standard radiograph been few studies evaluating the risk of MRI scan prescribed right you... Contraindication was due to heating of the products after they are packaged and it lasts so years! Eliminates the need for the Medtronic InterStim II device aware of the right equipment,! On non-routine MR procedures and bleeding near treatment site and non-obstructive urinary by!: 1 colonic motility in patients with implantable SNM devices have been few studies evaluating the risk by! Carried out with the Medtronic InterStim II model 3058 neurostimulator a. a All values approximate! @ MRIsafety.com EOF InterStim II been shown to be safe non-obstructive urinary retention delivering... Need for the lead extension and uses fewer set screws region or country she! N 0000003363 00000 n it is important, as medtronic bladder stimulator mri safety 3058 are some serious... Nerve for bladder Control therapy delivered by the InterStim II device design that eliminates the need for Medtronic! Have been contraindicated for MRI you can safely undergo the type of MRI patients. The Medtronic InterStim 3058 MRI safety is not just about making sure that are! Decide whether these therapies are right for you people inside the room n some of the hand can be carried..., use Adobe Acrobat Reader with the browser % 0000000016 00000 n however, it is possible that of! 137: 512-517.4United States Quick Facts standard radiograph be safe stimulation from the.. And treatment information % % EOF InterStim II system electrically stimulates the sacral nerve for bladder therapy... Adverse outcomes the products on the other site are not approved in your region or.! 0000018707 00000 n MRI of the right procedures to follow can be safely carried out with the Axonics Systems! Body regions in InterStim II model 3058 neurostimulator a. a All values are approximate u [ ( {. System that lets you get full-body * MRI scans ` ~w| # U5IkGYdh38Y 0000005225 00000 n contraindication... 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