medtronic bladder stimulator mri safety 3058

He or she works closely with the MR medical director and MR safety officer. 0000017570 00000 n 0000016458 00000 n 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). 0000004887 00000 n Patients 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. a)&|@a3ix g].3&^.jFMO5a 9>sa6 ~Ay@Z/l^/!6pLb+{Mk 0000041486 00000 n Healthcare Professionals 0000008924 00000 n Less than NBV132955H ? 2005;8(4)495-505.8Yeaw J, Benner JS, Walt JG, Sian S, Smith DB, et al. 0000012562 00000 n Depuy Barrels-Product Line is now a Zimmer Biomet Product, Zimmer Austin-Moore Fenestrated Hip Implants, 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 smart programmer for clinicians, TYRX neuro absorbable antibacterial envelope, Experience urge incontinence or urgency-frequency, Experience urinary retention without an obstruction, Need another option if medication does not provide symptom relief and/or causes unpleasant side effects, Want an alternative to repeated injections, Have not demonstrated an appropriate response to the InterStim/therapy evaluation, Are unable to operate mobile devices (such as the smart programmer for the InterStim system), Are not appropriate candidates for surgery, Experience retention due to obstructions (such as BPH, cancer, or urethral stricture), Experience urge incontinence and/or passive incontinence, Need another option if medication that does not provide symptom relief and/or causes unpleasant side effects, Have issues using mobile devices (such as the smart programmer for the InterStim system). Y{p._(u[(|{-[=Wbx7TJCvSVvjiTB.|Ug`~w|#U5IkGYdh38Y. xref 0000018863 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 Leng WW, Chancellor MB. Urol Clin North Am. 0000023883 00000 n m InterStim II Model 3058 Neurostimulator Table 1. ?? He or she also provides advice on non-routine MR procedures. POR can occur when there is a temporary fluctuation in battery voltage (eg . 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. 0000006753 00000 n It is safe and effective. 0000018197 00000 n If using an MRI SureScan device, see the MRI SureScan technical manual before performing an MRI. 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. MRI: Testing of the VOCARE Bladder System/Finetech-Brindley Bladder System (Vocare) in a 1.5-Tesla scanner with a maximum spatial gradient of 450 gauss/cm or less, exposed to an average Specific Absorption Rate (SAR) of 1.1 W/kg, for a 30 minute duration resulted in localized temperature rises up to 5.5?C in a gel phantom (without blood flow . Accessed July 19, 2016.5Dmochowski RR, Newman DK. 0000014626 00000 n 0000009598 00000 n 4.2. 0000009883 00000 n 0000016814 00000 n 0000006231 00000 n Patients with InterStim MRI Leads only. Under certain conditions; see approved labeling for details. 0000009458 00000 n 0000010275 00000 n Serial numbers ineligible for MRI scans (Model 3023 Neurostimulator only). Less information (see less). hbbd```b``^"w L 5(09"z@d)6yd&` e:S&F=`iE It is possible that some of the products on the other site are not approved in your region or country. 0000007197 00000 n Fecal incontinence in US adults: epidemiology and risk factors. The Interstim II system may be suitable for most people because it's simple, convenient and lower maintenance.3. Persistence and adherence of medications for chronic overactive bladder/urinary incontinence in the California Medicaid Program. Rh)b#0a(Z)#!H Bb*acH@L Q 9 , p043/aeSe3JEANr3>-u8wFXGp. 0000013304 00000 n For applicable products, consult instructions for use onwww.medtronic.com/manuals. The effect of sacral nerve stimulation on distal colonic motility in patients with fecal incontinence. 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: ? 0000001682 00000 n Home Shipping, operating, and power-on-reset (POR) values for the Medtronic InterStim II Model 3058 Neurostimulator a. a All values are approximate. 0000016410 00000 n 0000025647 00000 n Search by model name, product name, or device type. 0000002333 00000 n 0000008954 00000 n Patton V, Wiklendt L, Arkwright JW, Lubowski DZ, Dinning PG. The neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. 0000016308 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. It uses an implanted stimulator to deliver electrical pulses through a lead wire to electrodes located near the sacral nerve. Implanted pulse generators were examined before and after MRI procedures. Your doctor should discuss all potential benefits and risks with you. We are Medtronic. ", "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. 0000009317 00000 n Due to increased risk of neurostimulator damage, patients implanted with InterStim Model 3023 Neurostimulators with the following serial numbers should not have MRI scans. 0000006938 00000 n 0000008625 00000 n 0000006501 00000 n Its also important to note that the updated label is the result of several years of collaborative effort between Medtronic, the Medicines and Healthcare products Regulatory Agency (MHRA), and other MRI device manufacturers. Products In August 2020, the FDA approved the InterStim Micro neurostimulator and InterStim SureScan MRI leads for the treatment of patients with bladder and bowl control conditions. 0000017618 00000 n 0000007795 00000 n "This is not your grandmother's therapy. 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. 0 Safety and effectiveness have not been established for pregnancy and delivery; patients under the age of 16; or for patients with neurological disease origins. Several precautions should be taken, including selecting the appropriate coil and positioning the patient outside the MRI scanner room. 0000011736 00000 n 0000010287 00000 n If you are a doctor, you should be familiar with MRI safety guidelines. 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. 0000005225 00000 n hb```b``^d(31 PCAed a2(m``_XA -cMt8{}*[e%A*AN)O0!!6FIIeAaRE#,XMtabX;'1wjg t7eD,zorsaR; ;@xR+ Pelvic floor disorders network. 0000008298 00000 n 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. The new guidelines add to Medtronics existing MRI label, which includes a comprehensive MRI Safety Guidance. Medtronic 3058 Interstim II Neurostimulator for Bladder and Bowel Control. nmVe:D\YC]R Ab Z 1.5T and 3T head coil MRI scans. 0000025529 00000 n 0000009645 00000 n This small electro-optical device is not only a cool-looking device, but it does not affect the quality of your MRI images. Implanted pulse generators were examined before and after MRI procedures. 427 0 obj <> endobj `ir8s]:FQpyibR-`,}8my) b&(bN (o|w o Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. 0000014184 00000 n These instructions do not apply to other implantable products, or other devices, products, or items. 0000014881 00000 n 0000025277 00000 n The InterStim II system a recharge-free, long-term therapy that lets patients get full-body* MRI scans. 0000000016 00000 n If you arent, you might as well find a urologist to help you out. Learn the parameters of patient selection for bladder control and bowel control. 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 Between NBV133037H and NBV133063H ? 2007;23:65-76.6Leede Research, "Views on OAB: A Study for the National Association of Continence." 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). 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). 2009;137: 512-517.4United States Quick Facts. Considering that the InterStim is a ubiquitous presence in the bladder department, MRI safety is a must. b Power-on-reset (POR) turns OFF stimulation by resetting the amplitude to 0.0 V and all electrodes to OFF. neurostimulator will provide stimulation at programmed settings before requiring recharge). Hg1}Y@d3}quQ D~+ This is important, as there are some very serious consequences if you are not aware of the right procedures to follow. 446 0 obj <>stream ?? Urol Clin North Am. endstream endobj 307 0 obj <>stream 0000018445 00000 n 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. 0000009137 00000 n 884 0 obj 0000028229 00000 n Home 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 Please talk to your doctor to decide whether these therapies are right for you. 2005;32:1118. Some of these interactions, especially heating, are potentially hazardous and can lead to serious or permanent patient injury. Prevalence and burden of overactive bladder in the United States. 756 0 obj Update my browser now. InterStim systems are the standard of care in advanced therapy options . The purpose of the MR safety expert is to minimize risk and optimize scan plans. These updates also allow for a shorter waiting time between MRI scans. 5Z\&l:|iXeMt+Z5|L| 1v 3tT#`K?FWrS8% This includes a new B1+rms technology for 1.5Tesla scans, and an updated label that adds more flexibility to clinicians practices. Unintended Stimulation MRI may cause unintended stimulation from the implant. 0 United States Census Bureau Web site. HVI[1S#gUY9g- A7 RO$Z2NKHo-^]w_EjX1]2gm]dMj-Bm&*y, tum.5vam.q 6eHAUIIv1^xl-C`;"%Wl 0HC8h~cL! However, it is important to consider the risk posed by your specific MRI scan parameters. Update my browser now. Important Safety Information, Medtronic Bladder Control Therapy delivered by the InterStim system, Medtronic Bladder Control Therapy delivered by the NURO system. However, the safety of MRI of other body regions in InterStim II patients remains uncertain. How sacral nerve stimulation neuromodulation works. MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. 0000015970 00000 n 0000017228 00000 n endstream endobj 305 0 obj <>stream 0000018493 00000 n More information (see more) b Power-on-reset (POR) turns OFF stimulation by resetting the amplitude to 0.0 V and all electrodes to OFF. The manufacturers sterilize the products after they are packaged and it lasts so many years. 0 <<8176020B0CB4AE4A9F0BF88D5F2A90DE>]/Prev 621018>> %%EOF 2 InterStim Micro treats patients with overactive bladder, fecal incontinence, and non-obstructive urinary retention by delivering SNM therapy. 0000008397 00000 n 0000004448 00000 n 0000012610 00000 n You must demonstrate an appropriate response to the evaluation to be a candidate. For more information on Medtronic (NYSE:MDT), visit www.Medtronic.comand follow @Medtronic on Twitter and LinkedIn. startxref . 0000010599 00000 n 0000004045 00000 n Historically, patients with implantable SNM devices have been contraindicated for MRI. 0000000016 00000 n You just clicked a link to go to another website. 0000010323 00000 n MRI mode is easy for patients to independently activate or deactivate on the smart programmer. MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. With an updated browser, you will have a better Medtronic website experience. J Manag Care Pharm. 0000010503 00000 n Sacral Neuromodulation Systems 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. 0000006985 00000 n The good news is that many physicians are already familiar with the subject. In fact, many of them might be considering the InterStim in the near future. The new labeling also decreases wait time from 60 minutes to 5 minutes for maximum duration scans (30 minutes). <> MR safety expert is a person who is responsible for developing a local and safe MR safety framework. 0000018911 00000 n Manuals can be viewed using a current version of any major internet browser. 0000005392 00000 n aiip ,@+er(Na[SI]$H-Gje*E q9L-k#:yDY$81*vw*h 0000006555 00000 n Search for downloadable product manuals by product name or model number. InterStim II. Your use of the other site is subject to the terms of use and privacy statement on that site. That said, you have to ask yourself, are you a patient? How sacral nerve stimulation neuromodulation works. Medtronic InterStim 3058 MRI safety is not just about making sure that you are using the right equipment. 0000017893 00000 n Ll2@108 <<643BDC4F02F463BA264A9A2366C35000>]>> endstream endobj 302 0 obj <> endobj 303 0 obj <> endobj 304 0 obj <>stream Br J Surg. Spinal Cord Stimulation, SureScan MRI Version, Medtronic, Inc. Do not use if the skin in the area of use is compromised. The clinician uses the Clinician app to . xref The following information describes the potential interactions and control measures that should be taken to minimize the risks from these interactions. Expiration dates have mostly to do with sterilization and not the integrity of the product. Eight MRI examinations at 1.5 Tesla were conducted in areas outside the pelvis on six patients with implanted sacral nerve stimulator (InterStim neurostimulator; Medtronic, Inc, Minneapolis, MN, USA). 0000009782 00000 n 0000005846 00000 n Adverse events are typically temporary, and include mild pain, minor inflammation and bleeding near treatment site. endstream endobj 428 0 obj <. If this patient is implanted with an InterStim II Model 3058 Neurostimulator or an eligible serial number of an InterStim Model 3023 Neurostimulator (when implanted as a system including a neurostimulator, lead, and extension as applicable), MRI examinations of the head only may be safely performed under the following conditions: It's exciting to tell patients about the personalized, discreet, smart tech-enabled InterStim choices they now have for long-term relief. j 0000015308 00000 n About MedtronicBold thinking. HUMs6Wlo86;L,fzJTI4 i&p\}xX.@1Tn`}!a[z$WC@WH0)zK61xD"6Vqyu*^pJ3hAX638}Iv=M$ ZDp`2fK3F_E} J jV?hOS1Eg{y 0000010106 00000 n 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. For further information, contact your local Medtronic representative and/or consult the Medtronic website at medtronic.eu website. In addition, a thorough investigation must be conducted before any MR equipment is placed in a facility. This unintended stimulation may be uncomfortable (e.g., tingling, shocking, or jolting). Some of these interactions, especially heating, are potentially hazardous and can lead to serious or permanent patient injury. Urological 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 . 0000009089 00000 n 0000005793 00000 n 0000018959 00000 n 0000006023 00000 n 0000010551 00000 n 0000001914 00000 n %%EOF 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). Impact of overactive bladder on women in the United States: results of anational survey. See the device manual for detailed information regarding the instructions for use, indications, contraindications, warnings, precautions, and potential adverse events. 0000016760 00000 n This therapy is not intended for patients with a urinary blockage. 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'[. These components are well depicted on a standard radiograph. The following information describes the potential interactions and control measures that should be taken to minimize the risks from these interactions. ?? This therapy isappropriatefor bladder control patients who: This therapy isnot appropriatefor bladder control patients who: Many patients with chronic FI have poor or reduced quality of life because of their symptoms. 0000065437 00000 n REFERENCE