medtronic bladder stimulator mri safety 3058

endstream endobj 306 0 obj <>stream Although many patients may benefit from the use of these treatments, results may vary. This therapy is not intended for patients with a urinary blockage. 0000008679 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. Shipping, operating, and power-on-reset (POR) values for the Medtronic InterStim II Model 3058 Neurostimulator a. a All values are approximate. 0000016362 00000 n Rh)b#0a(Z)#!H Bb*acH@L Q 9 , p043/aeSe3JEANr3>-u8wFXGp. 0000005583 00000 n 0000013304 00000 n InterStim II. Br J Surg. This manual provides information for use in estimating battery longevity (the number of months or years that the 756 129 0 HUMs6Wlo86;L,fzJTI4 i&p\}xX.@1Tn`}!a[z$WC@WH0)zK61xD"6Vqyu*^pJ3hAX638}Iv=M$ ZDp`2fK3F_E} J jV?hOS1Eg{y MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. 0000016458 00000 n 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. Home ?? Urol Clin North Am. 0000007625 00000 n 0000010222 00000 n Copyright 2023 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. He or she works closely with the MR medical director and MR safety officer. Some of these interactions, especially heating, are potentially hazardous and can lead to serious or permanent patient injury. For further information, please call Medtronic at 1-800-328-0810 and/or consult Medtronics website at www.medtronic.com. Get the details on specific MRI compatibility for neuromodulation therapies. 0000027823 00000 n 0000013412 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). If you continue, you may go to a site run by someone else. `ir8s]:FQpyibR-`,}8my) b&(bN (o|w o However, if the conditions for safe MRI are 0000004494 00000 n 0000009137 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: Methods. 0000023719 00000 n With an updated browser, you will have a better Medtronic website experience. ATTENTION: READ THE FULL LABELING FOR THIS INFORMATION BEFORE CONDUCTING AN MRI EXAMINATION IN A PATIENT WITH THIS DEVICE. 0000006938 00000 n 1.5T and 3T head coil MRI scans. 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: Medicare and many other private insurance companies cover Medtronic Bladder Control Therapy. 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: ? There have been few studies evaluating the risk of MRI in patients with this implant. 0000014136 00000 n This contraindication was due to heating of the electrodes, which could damage neural tissue. You just clicked a link to go to another website. Patton V, Wiklendt L, Arkwright JW, Lubowski DZ, Dinning PG. ;zrz'm,E*|3;aB.v` qRy Click OK to confirm you are a Healthcare Professional. Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced it received approval from the U.S. Food and Drug Administration (FDA) for InterStim X the next generation DUBLIN, Feb. 22, 2022 /PRNewswire/ --Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced it received approval from the U.S. Food and Drug Administration (FDA) for InterStim X the next generation of the InterStim portfolio's recharge-free device and it is available immediately. MRI of the lumbar and pelvic regions with the Medtronic Interstim II (model 3058) stimulator has been shown to be safe. ", 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. Please talk to your doctor to decide whether these therapies are right for you. 0000008350 00000 n 0000006657 00000 n If you have an implanted neurostimulator and are going to undergo an MRI scan, you should take the following steps: 1. endobj DUBLIN, Feb. 22, 2022 /PRNewswire/ -- Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced it received approval from the U.S. Food and Drug Administration (FDA) for InterStim X the next generation of the InterStim portfolio's recharge-free device - and it is available immediately. Available at: https://www.census.gov/quickfacts/table/ PST045215/00. 1-(800)-723-4636 (Tachy) 1-(800)-505-4636 (Brady) International Technical Centers. 0000016410 00000 n 2M XF"EEN"cL D3 0000001914 00000 n a)&|@a3ix g].3&^.jFMO5a Copyright 2022 / interstim.net - All rights reserved! 0000006184 00000 n 0000014402 00000 n 0000018755 00000 n REFERENCE