MRI Guidelines for InterStim Therapy neurostimulation systems
Contents
1. Clinician Programmer cannot be used to change or verify neurostimulator settings Use the Model 3037 Patient Programmer to turn the neurostimulator off and reduce the amplitude to 0 0 V If the magnet switch is enabled the patient may experience uncomfortable or unintended stimulation during the MRI scan If an active program with bipolar electrode settings is used bipolar mode the likelihood of uncomfortable stimulation during an MRI scan will be reduced The patient should be instructed to see the implanting physician or managing physician to verify neurostimulator function after the MRI head scan 9 Ensure that the head coil is a transmit receive head coil Note If you are unsure if your MRI system has RF transmit receive head coil capability check with the MRI equipment manufacturer Do not use a receive only head coil or an RF transmit body coil because of the risk of heating and potential nerve and tissue damage during MRI scans 10 Instruct the patient to immediately inform the MRI operator if any discomfort unexpected stimulation shocking or heating occurs during the examination 11 Verify that all proposed MRI examination parameters comply with the MR scanning conditions on page 5 of this manual If these conditions cannot be met do not proceed with the MRI examination During an MRI head scan Conduct the MRI head scan in Normal operating mode only Do not scan in First level controlled operating mode because2. amp Medtronic MRI Guidelines for InterStim Therapy neurostimulation systems Instructions for use 1USA Rx only Explanation of symbols on product or package labeling Refer to the appropriate product for symbols that apply Conformit Europ enne European Conformity This symbol means that the device fully complies with AIMD Directive 90 385 EEC NB 0123 and R amp TTE Directive oN MA 0123 1999 5 EC EC REP Authorized representative in the European community Manufacturer For USA audiences only e gE Magnetic Resonance MR Conditional Magnetic Resonance MR Unsafe 2012 02 MRI Guidelines for InterStim Therapy neurostimulation systems English 1 Medtronic InterStim InterStim iCon N Vision and SoftStart Stop are trademarks of Medtronic Inc registered in the U S and other countries 2 English MRI Guidelines for InterStim Therapy neurostimulation systems 2012 02 Table of contents Description 5 MR scanning conditions 5 MRI and InterStim Therapy 5 Information for prescribers 5 Warnings 5 Precautions 7 MRI head scan using an RF transmit receive head coil 8 Preparing for an MRI head scan 8 During an MRI head scan 10 After an MRI head scan 11 Patient programmer instructions for MRI technicians 11 InterStim iCon Model 3037 Patient Programmer instructions 11 Refer to the Indications Insert for indications and related information Refer to the appropri
3. and the risk of uncomfortable unintended stimulation often described as shocking or jolting sensation is justified Ensure that the electrodes remain off during the MRI scan by turning the neurostimulator off If the neurostimulator cannot be turned off eg because the battery is depleted which may occur in an abandoned or unused system and the neurostimulator programmed in a unipolar configuration ie the case is programmed as a positive electrode is on during the MRI examination the likelihood of undesired MRI induced effects eg shocking and jolting increases dramatically Patient interaction during MRI If possible do not sedate the patient so that the patient can provide feedback of any problems during the examination Monitor the patient during the MRI examination Verify that the patient is feeling normal and is responsive between each individual scan sequence of the MRI examination Discontinue the MRI immediately if the patient experiences any heating pain shocking sensations uncomfortable stimulation or unusual sensations 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 Less than NBV132955H Between NBV133037H and NBV133063H Between NBV628045S and NBV628263S Control magnet function after MRI Model 3023 Neurostimulator
4. only Do not conduct an MRI scan if the patient can only use a control magnet to turn the neurostimulator on or off An MRI scan may permanently damage the magnet switch in the neurostimulator If the magnet switch in the neurostimulator is damaged the patient will require a patient programmer to turn the neurostimulator on or off MRI head scan using an RF transmit receive head coil Ae all of the instructions stated in this manual are followed MRI examinations of the head only using a 1 5 T horizontal closed bore MRI system with an RF transmit receive head coil may be safely performed Preparing for an MRI head scan Prior to performing an MRI head scan on a Medtronic InterStim Therapy patient 1 Determine whether the patient has any other implants or conditions that would prohibit or contraindicate an MRI examination The most restrictive MRI exposure requirements must be used if the patient has multiple active medical device implants Contact the appropriate device manufacturers if you have questions If the following requirements cannot be met do not proceed with the MRI examination 8 English MRI Guidelines for InterStim Therapy neurostimulation systems 2012 02 2 Verify the implant location of the InterStim Therapy system and ensure that the InterStim Therapy system will not be inside the transmit receive head coil Do not use the RF transmit body coil Note When implanted per approved indications InterStim Therapy components
5. 00 Germany Medtronic GmbH Tel 02159 81490 Fax 02159 8149100 Greece Medtronic Hellas S A Tel 210 67 79 099 Fax 210 67 79 399 Hungary Medtronic Hungaria Kft Tel 1 889 06 00 Fax 1 889 06 99 Ireland Medtronic Ireland Ltd Tel 01 890 6522 Fax 01 890 7220 Italy Medtronic Italia SpA Tel 02 241371 Fax 02 241381 Tel 06 328141 Fax 06 3215812 Japan Medtronic Japan Tel 03 6430 2016 Fax 03 6430 7110 Latin America Medtronic Inc Tel 1305 500 9328 Fax 1786 709 4244 Norway Medtronic Norge AS Tel 067 10 32 00 Fax 067 10 32 10 Poland Medtronic Poland Sp z o o Tel 022 465 69 00 Fax 022 465 69 17 Portugal Medtronic Portugal Lda Tel 21 724 5100 Fax 21 724 5199 Russia Medtronic Russia Tel 8495 580 7377 Fax 8495 580 7378 Slovakia Medtronic Slovakia o z Tel 0268 206 911 Fax 0268 206 999 Spain Medtronic Ib rica S A Tel 91 625 0400 Fax 91 650 7410 Sweden Medtronic AB Tel 08 568 585 00 Fax 08 568 585 01 Switzerland Medtronic Schweiz AG Tel 031 868 0100 Fax 031 868 0199 The Netherlands Medtronic B V Tel 045 566 8000 Fax 045 566 8668 U K Medtronic U K Ltd Tel 01923 212213 Fax 01923 241004 USA Medtronic Inc Tel 1763 505 5000 Fax 1763 505 1000 Toll free 1 800 328 0810 Medtronic Alleviating Pain Restoring Health Extending Life Manufacturer asal Me
6. 012 02 MRI Guidelines for InterStim Therapy neurostimulation systems English 5 contains ferromagnetic material which can be affected by the MRI magnet and is unsafe in the MRI environment MRI RF transmit body coil Do not use an RF transmit body coil or a receive only head coil Serious patient injury could result MRI transmit receive head coil An MRI examination of the head only no other part of the body has been tested can be conducted safely using an RF transmit receive head coil when all instructions in this manual are followed Limitations These instructions apply only to Medtronic InterStim Therapy neurostimulation systems for approved indications listed as eligible for an MRI head scan Prior to an MRI head scan determine whether the patient has multiple active medical device implants such as deep brain stimulation systems implantable cardiac defibrillators and others The most restrictive MRI exposure requirements must be used if the patient has multiple active medical device implants Contact the appropriate device manufacturers if you have questions If you are unclear what implants may be present perform an x ray to determine implant type and location Scans must be limited to 1 5 T horizontal closed bore MRI systems Use of different MRI systems such as open bore or 3 0 T MRI is not permitted because it may expose the patient to unacceptable or unknown risks Do not place any part of the implanted system w
7. are outside of the head coil 3 Inform the patient of the risks of undergoing an MRI Note Patients should always inform healthcare personnel that they have an implanted neurostimulation system before any medical procedure begins 4 If possible do not sedate the patient so that the patient can provide feedback of any problems during the examination 5 If the patient does not use a Model 3037 Patient Programmer instruct the patient to see the implanting physician or managing physician to confirm MRI head scan eligibility refer to Table 1 and neurostimulator settings for MRI refer to Table 2 using the Model 8840 Clinician Programmer 6 Determine the implanted neurostimulator model Check the current Patient ID card or use the InterStim iCon Model 3037 Patient Programmer or N Vision Model 8840 Clinician Programmer Note Refer to the InterStim iCon Model 3037 Patient Programmer instructions on page 11 or the appropriate programmer manual for additional instructions for use 7 Review Table 1 and use the implanted neurostimulator model to determine MRI head scan eligibility Eligibility for an MRI head scan is limited to specific neurostimulator models and serial number series Table 1 MRI head scan eligibility by neurostimulator model Model Description Eligibility details 3058 InterStim II All Model 3058 Neurostimulators serial numbers be ginning with NJY are eligible for head coil only MRI scans 3023 InterStim Chec
8. ate Information for Prescribers booklet for contraindications warnings precautions adverse events summary individualization of treatment patient selection use in specific populations resterilization and component disposal Refer to System Eligibility Battery Longevity Specifications reference manual for neurostimulator selection battery longevity calculations and specific neurostimulator specifications 2012 02 MRI Guidelines for InterStim Therapy neurostimulation systems English 3 4 English MRI Guidelines for InterStim Therapy neurostimulation systems 2012 02 Description MR scanning conditions MR Conditional Non clinical testing has demonstrated that InterStim Therapy systems have been found to be MR Conditional If this patient is implanted with an InterStim Il 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 1 5 Tesla T horizontal closed bore a 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 If possible do not sedate the patient Model 3058 and eligible Model 3023 Neurostimulators Turn the neurostim
9. conducting an MRI head scan Scans conducted using other modes eg First level controlled operating mode may increase the risk of shocking sensations uncomfortable stimulation or unusual sensations during MRI scans Gradient limitation Limit the gradient slew rate to 200 T m s or less Exposure to gradient systems with a gradient slew rate exceeding 200 T m s may result in overstimulation or shocking particularly for unipolar capable devices Scanning frequency of approximately 64 MHz only Do not conduct MRI scans with nonproton scanning frequencies such as 13C 23Na or 31P Frequencies other than 64 MHz have not been tested RF transmit receive head coil only Use a transmit receive head coil to limit RF exposure to the head only and ensure that the neurostimulator is well outside of the RF field Do not use a receive only head coil because it increases the risk of heating and potential nerve and tissue damage during MRI scans Neurostimulator settings during the MRI examination Before conducting an MRI scan turn the neurostimulator off For the Model 3023 Neurostimulator disable the Magnet 2012 02 MRI Guidelines for InterStim Therapy neurostimulation systems English 7 Switch Failure to use these settings could result in uncomfortable unintended stimulation during the MRI examination If the neurostimulator is not turned off or cannot be confirmed to be off the scan should not be performed unless it is a medical emergency
10. dtronic Inc 710 Medtronic Parkway Minneapolis MN 55432 5604 USA www medtronic com Tel 1 763 505 5000 Fax 1 763 505 1000 EC REP Authorized Representative in the European Community Medtronic B V Earl Bakkenstraat 10 6422 PJ Heerlen The Netherlands Tel 31 45 566 8000 Fax 31 45 566 8668 Europe Africa Middle East Headquarters Medtronic International Trading S rl Route du Molliau 31 Case Postale 84 CH 1131 Tolochenaz Switzerland www medtronic eu Tel 41 21 802 7000 Fax 41 21 802 7900 Asia Pacific Medtronic International Ltd Suite 1106 11 11 F Tower 1 The Gateway 25 Canton Road Tsimshatsui Kowloon Hong Kong Tel 852 2919 1362 Fax 852 2907 3998 Contacts for specific countries are listed inside this cover 9 4 002 M947945A All Rights Reserved M947945A002 Medtronic Inc 2012 0
11. higher SAR and gradient levels are permitted 10 English MRI Guidelines for InterStim Therapy neurostimulation systems 2012 02 Monitor the patient both visually and audibly Check the patient between each imaging sequence Discontinue the MRI examination immediately if the patient reports any problems or has any discomfort During the MRI head scan the patient may feel tugging and or vibration of the neurostimulator If the tugging or vibration causes the patient considerable discomfort stop the MRI head scan After an MRI head scan Verify that the patient has not experienced adverse effects as a result of the MRI head scan Contact Medtronic to report any adverse effects Restore the neurostimulator settings to pre MRI head scan values Instruct the patient to see the implanting physician or managing physician if the patient has any questions about neurostimulator function if assistance is required to return program parameters to pre MRI head scan settings if the patient programmer displays a power on reset POR screen Patient programmer instructions for MRI technicians These instructions are for the use of the InterStim iCon Model 3037 Patient Programmer at the patient s MRI appointment For additional instructions refer to the Model 3037 Patient Programmer user manual InterStim iCon Model 3037 Patient Programmer instructions Decrease Increase Neurostimulator on Neurostimulator off Sync Navigat
12. ithin the RF transmit receive head coil Excessive heating can cause tissue damage and result in serious or permanent patient injury Ifthe system is removed remove all portions of the neurostimulation system to allow for future MRI scans Even partial systems can have MRI interactions such as RF heating Excessive heating can cause tissue damage and result in serious or permanent patient injury Risks associated with MRI examination Exposing a patient with an implanted neurostimulation system or component to MRI settings other than those listed in this manual may potentially injure the patient or damage the neurostimulator The known potential risks are as follows Induced electrical currents from the MRI to the neurostimulation system or component may cause heating especially at the lead electrode site resulting in tissue damage Note This warning applies even if only a lead or extension is implanted Factors that increase the risks of heating and tissue damage include but are not limited to the following Higher MRI Specific Absorption Rate SAR RF power levels MRI RF transmit receive coil that is near or extends over the implanted lead including abandoned leads or portions of leads 6 English MRI Guidelines for InterStim Therapy neurostimulation systems 2012 02 Induced electrical currents may also stimulate or shock the patient depending on the potential circuit paths the exposure to the pulsed gradient magnetic field
13. k the serial number No MRI scans if the serial number is Less than NBV132955H Between NBV133037H and NBV133063H Between NBV628045S and NBV628263S 7427T InterStim Twin No MRI scans a If a programmer is used to check the neurostimulator serial number the letter suffix H or S may not appear 8 Using the eligible neurostimulator model review Table 2 and use the appropriate programmer to change or verify the program settings to comply with neurostimulator settings for an MRI head scan 2012 02 MRI Guidelines for InterStim Therapy neurostimulation systems English 9 Note Before changing a neurostimulator program setting record the current setting so that the neurostimulator can be programmed to pre MRI program settings following the MRI examination Table 2 Recommended neurostimulator settings for an MRI head scan Model Programmer Settings 3058 Model 3037 Patient Programmer Turn the neurostimulator off 3023 Model 8840 Clinician Programmer Turn the neurostimulator off and disable the magnet switch a For the Model 3023 Neurostimulator the Model 8840 Clinician Programmer is required to disable the magnet switch If you have verified that the magnet switch has been disabled the Model 3037 Patient Programmer may be used to turn the neurostimulator off Note For an emergency MRI head scan on a patient implanted with the Model 3023 Neurostimulator If an emergency MRI head scan is required and the Model 8840
14. lect a program 3 Synchronize the programmer and neurostimulator 4 Verify that the program is active M Figure 4 Programmer screen showing an active program Increasing or decreasing amplitude 1 Synchronize the programmer and neurostimulator 2 While holding the programmer over the neurostimulator Press the Decrease key to decrease amplitude Press the Neurostimulator on key and then press the Increase key to increase amplitude all Amplitude Figure 5 Programmer screen showing an amplitude of 2 0 V 2012 02 MRI Guidelines for InterStim Therapy neurostimulation systems English 13 Contacts Asia Medtronic International Ltd Tel 02919 1362 Fax 02907 3998 Medtronic Asia Ltd Tel 02 548 1148 Fax 02 518 4786 Australia Medtronic Australasia Pty Ltd 97 Waterloo Road North Ryde NSW 2113 Australia Tel 61 2 9857 9000 Fax 61 2 9878 5100 Toll free 1 800 668 6700 Austria Medtronic Osterreich GmbH Tel 01 240440 Fax 01 24044 100 Belgium Medtronic Belgium S A Tel 02 456 0900 Fax 02 460 2667 Canada Medtronic of Canada Ltd Tel 1 905 460 3800 Fax 1905 826 6620 Czech Republic Medtronic Czechia s r o Tel 2 965 795 80 Fax 2 965 795 89 Denmark Medtronic Danmark A S Tel 45 32 48 18 00 Fax 45 32 48 18 01 Finland Medtronic Finland Oy LTD Tel 09 755 2500 Fax 09 755 25018 France Medtronic France S A S Tel 01 5538 1700 Fax 01 5538 18
15. or Figure 1 Model 3037 Patient Programmer keys 2012 02 MRI Guidelines for InterStim Therapy neurostimulation systems English 11 Synchronizing the programmer and neurostimulator Hold the programmer over the neurostimulator and press the Sync key Viewing the neurostimulator model and serial number To view the neurostimulator model IM and serial number IS information screens 1 Synchronize the programmer and neurostimulator 2 If using the patient s Model 3037 Patient Programmer press the Up arrow on the Navigator key 3 Press the Left arrow on the Navigator key once to select information screens 4 Press the Down arrow on the Navigator key 5 Press the Left or Right arrows on the Navigator key to scroll through each information screen until the neurostimulator model IM or serial number IS screens appear Figure 2 Figure 2 Neurostimulator model and serial number information screens Note Refer to Table 1 for information about using the neurostimulator model and serial number when determining MRI head scan eligibility Turning the neurostimulator on or off To turn the neurostimulator on or off hold the programmer over the neurostimulator and press the Neurostimulator on or off key Figure 3 Figure 3 Neurostimulator on and off keys 12 English MRI Guidelines for InterStim Therapy neurostimulation systems 2012 02 Changing a program 41 Synchronize the programmer and neurostimulator 2 Se
16. s and the pulsed RF field The static magnetic field pulsed gradient magnetic field and or the pulsed RF field generated by MRI may permanently damage the neurostimulator requiring explant or replacement MRI may affect the operation of the neurostimulator MRI may also reset the parameters to power on reset POR settings requiring reprogramming with the clinician programmer The neurostimulator may move within the implant pocket and align itself with the MRI field which may cause patient discomfort Precautions Obtain the latest MRI guidelines Always obtain the latest MRI guidelines Refer to the contact information on the last page of this manual or go to www medtronic com mri Enter the neurostimulator model on the website www medtronic com mri to obtain the latest version of the manual containing these guidelines Copies of these MRI guidelines may not be the most up to date version if not received directly from the website or in another manner from Medtronic at the time of the patient s MRI appointment N External devices are MR Unsafe in the MRI environment Do not bring any of the following Medtronic external control devices into the MRI scanner room Patient programmer Clinician programmer Control magnet These devices contain ferromagnetic material which can be affected by the MRI magnet and are unsafe in the MRI environment Normal operating mode MRI scans Use only Normal operating mode when
17. ulator off Eligible Model 3023 Neurostimulators only Disable the magnet switch Scanning under different conditions may result in severe patient injury or device malfunction 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 These instructions do not apply to other implantable products or other devices products or items Contact Medtronic at the appropriate address or phone number listed at the back of this manual if you have any questions MRI systems generate powerful electromagnetic fields that can produce a number of interactions with implanted components of the neurostimulation system Some of these interactions especially heating are potentially hazardous and can lead to serious or permanent patient injury The following information describes the potential interactions and control measures that should be taken to minimize the risks from these interactions Information for prescribers Warnings MRI during test stimulation Explant all test stimulation components if an MRI scan is required Physicians should not prescribe MRI for patients undergoing test stimulation or who have any neurostimulation system components that are not fully implanted MRI has not been evaluated with test stimulation components The external neurostimulator 2
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