{"id":31091,"date":"2012-08-16T16:32:27","date_gmt":"2012-08-16T20:32:27","guid":{"rendered":"http:\/\/blogs.nejm.org\/cardioexchange\/?post_type=news&#038;p=31091"},"modified":"2012-08-16T16:33:06","modified_gmt":"2012-08-16T20:33:06","slug":"fda-calls-for-imaging-of-implantable-cardiac-devices-with-riata-leads","status":"publish","type":"post","link":"https:\/\/blogs.nejm.org\/cardioexchange\/2012\/08\/16\/fda-calls-for-imaging-of-implantable-cardiac-devices-with-riata-leads\/","title":{"rendered":"FDA Calls for Imaging of Implantable Cardiac Devices with Riata Leads"},"content":{"rendered":"<p>The <a href=\"http:\/\/www.fda.gov\/Safety\/MedWatch\/SafetyInformation\/SafetyAlertsforHumanMedicalProducts\/ucm315718.htm\">FDA is recommending imaging studies<\/a> for patients whose implantable cardioverter\/defibrillator or cardiac resynchronization therapy defibrillator has Riata or Riata ST leads.<\/p>\n<p>The studies are to check for abnormalities in the leads&#8217; insulation, which can cause the devices to deliver inappropriate or no shock therapy. The abnormalities may be detected with two-view chest X-ray or fluoroscopy. The leads are manufactured by St. Jude Medical, which reported that there are some 79,000 Riata leads implanted in the U.S.<\/p>\n<p>The agency recommends close monitoring of affected patients, who should be notified of the risk. Patients who&#8217;ve not had a recent evaluation should get one, and their devices should be checked for electrical abnormalities. The FDA also advises that clinicians consider remote monitoring of patients.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>The FDA is recommending imaging studies for patients whose implantable cardioverter\/defibrillator or cardiac resynchronization therapy defibrillator has Riata or Riata ST leads. The studies are to check for abnormalities in the leads&#8217; insulation, which can cause the devices to deliver inappropriate or no shock therapy. The abnormalities may be detected with two-view chest X-ray or [&hellip;]<\/p>\n","protected":false},"author":494,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[11,13],"tags":[],"class_list":["post-31091","post","type-post","status-publish","format-standard","hentry","category-cardiac-imaging","category-electrophysiology"],"_links":{"self":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/31091","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/users\/494"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/comments?post=31091"}],"version-history":[{"count":0,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/posts\/31091\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/media?parent=31091"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/categories?post=31091"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.nejm.org\/cardioexchange\/wp-json\/wp\/v2\/tags?post=31091"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}