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1、IfYou'veExposedYourParadigmPumptoanMRI,YouNeedtoReadThisLindavonWartburgJul20,2007IfyourParadigmpumphasbeennotbeenexposedtopowerfulmagneticfields,suchasthosefoundnearMRImachines,youhavenothingtoworryabout.Goaboutyourmerrywayandkeepupthegoodwork.Intheunl
2、ikelyeventthatsuchexposurehasoccurred,however,youneedtobeawarethatitmaycausethepump'smotortomalfunctionandsignificantlyover-deliverinsulin,causingseverehypoglycemia.Asaresultofthispotential,theFDAhas,baseduponMedtronic'svoluntaryreport,identifiedcertain
3、ParadigmpumpsassubjecttoaClassIIrecall.(TheactionisdescribedbyMedtronicasaClassIIfieldcorrectionratherthanarecallbecausenopumpneedbereturnedunlessithasbeenactuallydamagedbymagneticexposure.)MedtronicreportsthatonApril24,2007,thecompanysentawarningletter
4、,enclosedinaredenvelope,to200,000Paradigmpumppurchasers,aswellto30,000healthcarepractitioners,includingeveryprescriberoftheirpumps,andeveryoneoftheover14,000MRIfacilitiesintheUnitedStates.Thepatientletterreadasfollows:Recently,wehavebecomeawareofcaseswh
5、ereexposuretoMagneticResonanceImaging(MRI)hasresultedindamagetothecomponentthatmonitorsandcontrolsthemovementofthemotorusedinMedtronicMiniMedParadigminsulininfusionpumps.Althoughtheinsulinpumpsexhibitedalarmsasaresultofthisdamage,insomecases,usershavecl
6、earedthesealarmsandcontinuedtousethepump.Undertheseconditions,theinsulinpumpwillexhibitsignificantover-deliveryofinsulin,potentiallycausingseverehypoglycemia.MedtronicMiniMed(alongwithotherinsulininfusionpumpmanufacturers)hasalwayscautioneduserstoavoide
7、xposingtheirinfusionpumptostrongmagneticfields,suchasthoseassociatedwithMRImachines.Untilrecently,alltestinghasindicatedthisexposurewouldcausesignificantpumpdamageandpreventMiniMedParadigminsulinpumpsfromdeliveringanyinsulinfollowingthisexposure.However
8、,wenowknowthatsignificantover-deliveryofinsulincanoccurfollowingthisexposure.Inlightofthisnewinformation,weareremindinginsulinpumpusersnottoexposeyourinsulinpumptostrongmagneticfieldssuchasthosegeneratedbyMRIequipment.YOURINSULIN
