0000009782 00000 n Patients World Population Prospects: The 2010 Revision, CD-ROM Edition.3Whitehead WE, Borrud L, Goode PS, et al. Methods: Eight MRI examinations at 1.5Tesla were conducted in areas outside the pelvis on six patients with implanted sacral nerve stimulator (InterStim neurostimulator; Medtronic, Inc, Minneapolis, MN, USA). If you continue, you may go to a site run by someone else. InterStim systems are the standard of care in advanced therapy options, and the most personalized system, to deliver sacral neuromodulation (SNM) therapy. 0000009830 00000 n Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. 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. 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. 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 . Urological <> Healthcare Professionals Not for human use in the US. 0000011083 00000 n Some of these interactions, especially heating, are potentially hazardous and can lead to serious or permanent patient injury. ", More than 37 million adults in the United States almost one in six suffer from overactive bladder (OAB),1,2 and nearly 18 million Americans about one in 12 are living with fecal incontinence.3,4 Many sufferers limit their lives socially, professionally, and personally.5 However, as many as 45% who suffer from symptoms do not seek treatment and as many as seven in 10 stop using medications within six months due to intolerable side effects or unsatisfying results.6,7,8. "As we celebrate 25 years of InterStim this year, we're bullish about our next chapter in patient-focused therapy innovation. See approved labeling for details. 0000012800 00000 n 0000041486 00000 n InterStim II. MRI, inform the MRI technologist immediately and then contact your doctor. These instructions do not apply to other implantable products, or other devices, products, or items. 0000006184 00000 n 0000004713 00000 n We are Medtronic. 0000016706 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:"?? POR can occur when there is a temporary fluctuation in battery voltage (eg . 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. 323 0 obj <>/Filter/FlateDecode/ID[<28836736925E656CEC1D4A45F6B26EFC><9F3AF6A1190447458124BACAF1002E60>]/Index[301 49]/Info 300 0 R/Length 113/Prev 1197727/Root 302 0 R/Size 350/Type/XRef/W[1 3 1]>>stream It is also about being aware of the proper way to conduct your exams and to ensure the safety of everyone involved. You must demonstrate an appropriate response to the evaluation to be a candidate. This contraindication was due to heating of the electrodes, which could damage neural tissue. 0000000016 00000 n 2005;32:1118. 446 0 obj <>stream World J Urol. 0000019081 00000 n 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: 301 0 obj <> endobj However, further studies should be performed to determine the safety of MRI in other body regions in InterStim II patients. 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). Br J Surg. 0000004372 00000 n 756 129 0 p;X``pe`.)N]KA@!0834X@wP t(p 4qgp)h` j{ ", "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. 0000005584 00000 n The new labeling also decreases wait time from 60 minutes to 5 minutes for maximum duration scans (30 minutes). . 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. Medtronic 3058 Interstim II Neurostimulator for Bladder and Bowel Control. 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. 0000014626 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. 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. 0000009458 00000 n 0000018911 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. stream Historically, patients with implantable SNM devices have been contraindicated for MRI. 0000012610 00000 n Patton V, Wiklendt L, Arkwright JW, Lubowski DZ, Dinning PG. 0000010599 00000 n 0000008625 00000 n 0000005392 00000 n It uses an implanted stimulator to deliver electrical pulses through a lead wire to electrodes located near the sacral nerve. 0000000696 00000 n Implanted pulse generators were examined before and after MRI procedures. If using an MRI SureScan device, see the MRI SureScan technical manual before performing an MRI. Expiration dates have mostly to do with sterilization and not the integrity of the product. 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. Adverse events are typically temporary, and include mild pain, minor inflammation and bleeding near treatment site. HVI[1S#gUY9g- A7 RO$Z2NKHo-^]w_EjX1]2gm]dMj-Bm&*y, tum.5vam.q 6eHAUIIv1^xl-C`;"%Wl 0HC8h~cL! 0000002333 00000 n These therapies are not for everyone. 1Stewart WF, et al. InterStim II. These components are well depicted on a standard radiograph. Although many patients may benefit from the use of these treatments, results may vary. 0000016018 00000 n Urol Clin North Am. This small electro-optical device is not only a cool-looking device, but it does not affect the quality of your MRI images. The manufacturers sterilize the products after they are packaged and it lasts so many years. The recharge-free InterStim neurostimulator streamlines the implant procedure with a design that eliminates the need for the lead extension and uses fewer set screws. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Tell the physician who prescribed your MRI scan that you have an implanted neurostimulation system. 0000005793 00000 n User Manual User Manual of 32 Navigation menu Upload a User Manual Wiki Guide Info User Manual Discussion / Help MRI safety guidelines from Medtronic have expanded the range of scan parameters that clinicians can use to provide patients with a comprehensive, reliable, and safe MRI experience. The implanted InterStim II system electrically stimulates the sacral nerve, which is thought to normalise neural communication between the bladder and brainand between the bowel and brain.1,2, Medtronic Bladder Control Therapy HUMs6Wlo86;L,fzJTI4 i&p\}xX.@1Tn`}!a[z$WC@WH0)zK61xD"6Vqyu*^pJ3hAX638}Iv=M$ ZDp`2fK3F_E} J jV?hOS1Eg{y Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. 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 . If you have an implanted neurostimulator and are going to undergo an MRI scan, you should take the following steps: 1. %PDF-1.3 % MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. For best results, use Adobe Acrobat Reader with the browser. Products 0000015970 00000 n Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. ATTENTION: READ THE FULL LABELING FOR THIS INFORMATION BEFORE CONDUCTING AN MRI EXAMINATION IN A PATIENT WITH THIS DEVICE. You cannot have diathermy (deep heat treatment from electromagnetic energy) if you have an InterStim device. Click OK to confirm you are a Healthcare Professional. InterStim II Model 3058 Neurostimulator Table 1. 9>sa6 ~Ay@Z/l^/!6pLb+{Mk In order to ensure safety in MR facilities, all personnel involved must understand safety procedures and be willing to communicate with each other. 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 0000018245 00000 n Bladder Control 884 0 obj 0000017618 00000 n 0000014402 00000 n With an updated browser, you will have a better Medtronic website experience. These instructions do not apply to other implantable products, or other devices, products, or items. Urol Clin North Am. 5Z\&l:|iXeMt+Z5|L| 1v 3tT#`K?FWrS8% MRI of the lumbar and pelvic regions with the Medtronic Interstim II (model 3058) stimulator has been shown to be safe. 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. 0000018809 00000 n 427 20 The Interstim system contains the aforementioned smart programmer, as well as a subcutaneous pulse generator (SPG) threaded through the S3 neural foramen. Do not use if the skin in the area of use is compromised. These treatments are prescribed by your doctor. The following information describes the potential interactions and control measures that should be taken to minimize the risks from these interactions. 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. The following information describes the potential interactions and control measures that should be taken to minimize the risks from these interactions. 0000004045 00000 n REFERENCE