The InterStim II system is the only recharge-free, long-termSNM system that lets you get full-body* MRI scans. 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. MRI of the hand can be safely carried out with the Medtronic Interstim II device. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. 0000012800 00000 n MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system. Do not use if the skin in the area of use is compromised. Not for human use in the US. 0000005392 00000 n 2009;137: 512-517.4United States Quick Facts. SureScan technology that enables full body 1.5T and 3T MRI scans under certain conditions and does not require impedance checks. 0000027856 00000 n POR can occur when there is a temporary fluctuation in battery voltage (eg . 0000004995 00000 n These updates also allow for a shorter waiting time between MRI scans. 0000011083 00000 n 4.2. a)&|@a3ix g].3&^.jFMO5a If you are a doctor, you should be familiar with MRI safety guidelines. +1 (305) 500-9328, - New InterStim X system provides 10 to 15 years of battery life without the need to recharge, - Medtronic bladder and bowel control portfolio offers the most personalized options to fit patient lifestyles, https://www.medtronic.com/us-en/index.html?intcmp=mdt_com_country_selector_dropdown_atlasr22016, Electromagnetic Compatibility Guide for Cardiac Devices, Electromagnetic Compatibility for Cardiac Devices, California Transparency in Supply Chains Act, Information About Proposition 65 for California Customers. ' a9.aacz3CSoTz)_%v ?? endstream endobj 302 0 obj <> endobj 303 0 obj <> endobj 304 0 obj <>stream Treatments & Therapies Prevalence and burden of overactive bladder in the United States. Many patients with OAB or retention have poor or reduced quality of life because of their symptoms. Tell the physician who prescribed your MRI scan that you have an implanted neurostimulation system. There have been few studies evaluating the risk of MRI in patients with this implant. Urological 0000000696 00000 n De Wachter S. et al New Technologies and Applications in Sacral Neuromodulation: An Update Adv Ther 37, 637-643 (2020). xref 0000015308 00000 n How sacral nerve stimulation neuromodulation works. 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. Implanted pulse generators were examined before and after MRI procedures. These components are well depicted on a standard radiograph. hbbd```b``^"w L 5(09"z@d)6yd&` e:S&F=`iE That said, you have to ask yourself, are you a patient? Update my browser now. 0000004372 00000 n trailer See approved labeling for details. 0000003363 00000 n 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. xUMHTQ=gS?X J"!sR$$JQH]"(AAPHm@D1DE6y|#Asw;J 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 Products 0000041486 00000 n Urol Clin North Am. This small device will improve patient satisfaction and reduce hospital readmissions. 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. 0000008954 00000 n b Power-on-reset (POR) turns OFF stimulation by resetting the amplitude to 0.0 V and all electrodes to OFF. Specifically, these guidelines expand the range of MRI scan parameters that clinicians can use, allowing them to offer patients with InterStim devices a wider array of MRI procedures. It is also about being aware of the proper way to conduct your exams and to ensure the safety of everyone involved. 0000005846 00000 n 1.5T and 3T upper and lower extremity MRI scans. Between NBV133037H and NBV133063H ? The Interstim system contains the aforementioned smart programmer, as well as a subcutaneous pulse generator (SPG) threaded through the S3 neural foramen. If using an MRI SureScan device, see the MRI SureScan technical manual before performing an MRI. 0000010599 00000 n "As we celebrate 25 years of InterStim this year, we're bullish about our next chapter in patient-focused therapy innovation. 0000028899 00000 n However, several studies have shown no serious adverse outcomes. Due to increased risk of neurostimulator damage, patients implanted with InterStim Model 3023 Neurostimulators with the following serial numbers should not have MRI scans. 0000007383 00000 n REFERENCE www.medtronic.com/mri. 0000010275 00000 n hb```b``^d(31 PCAed a2(m``_XA -cMt8{}*[e%A*AN)O0!!6FIIeAaRE#,XMtabX;'1wjg t7eD,zorsaR; ;@xR+ %%EOF "; 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:"?? +yLKxN5F`W82r Impact of overactive bladder on women in the United States: results of anational survey. 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Medtronic at 1-800-328-0810 and/or consult Medtronics website at www.medtronic.com II device manuals by product name or number...
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