{"id":1476,"date":"2017-05-01T07:02:38","date_gmt":"2017-05-01T12:02:38","guid":{"rendered":"https:\/\/www.masstortlawyerblog.com\/?p=1476"},"modified":"2018-04-12T12:36:18","modified_gmt":"2018-04-12T17:36:18","slug":"fda-issues-warning-letter-st-jude-medical-regarding-defective-defibrillator-batteries","status":"publish","type":"post","link":"https:\/\/www.molllawgroup.com\/blog\/fda-issues-warning-letter-st-jude-medical-regarding-defective-defibrillator-batteries\/","title":{"rendered":"FDA Issues Warning Letter to St. Jude Medical Regarding Defective Defibrillator Batteries"},"content":{"rendered":"<p>The U.S. Food and Drug Administration recently published a <a href=\"https:\/\/www.fda.gov\/ICECI\/EnforcementActions\/WarningLetters\/2017\/ucm552687.htm\" target=\"_blank\" rel=\"noopener noreferrer\">warning letter<\/a> that it sent to St. Jude Medical, stating that the company likely downplayed the risks associated with its defibrillator batteries last fall. A defibrillator is a device that provides an electric shock to the heart in the event it begins to beat irregularly or cease beating entirely. The device is implanted in the patient\u2019s chest and is battery powered.<\/p>\n<p>The letter also indicates that St. Jude may have failed to notify management officials within the company, in addition to its medical advisory board, that these battery-related issues resulted in the death of a patient.<\/p>\n<p>The letter also indicates that the agency has determined that St. Jude Medical has not taken sufficient or adequate measures to resolve the issue with the batteries. The company has 15 days to provide the FDA with a revised reporting plan.<\/p>\n<p> <a href=\"https:\/\/www.molllawgroup.com\/blog\/fda-issues-warning-letter-st-jude-medical-regarding-defective-defibrillator-batteries\/#more-1476\" class=\"more-link\">Continue reading \u2192<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>The U.S. Food and Drug Administration recently published a warning letter that it sent to St. Jude Medical, stating that the company likely downplayed the risks associated with its defibrillator batteries last fall. A defibrillator is a device that provides an electric shock to the heart in the event it begins to beat irregularly or [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[5],"tags":[],"class_list":["post-1476","post","type-post","status-publish","format-standard","hentry","category-medical-devices"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.4 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>FDA Issues Warning Letter to St. Jude Medical Regarding Defective Defibrillator Batteries &#8212; Illinois Injury and Mass Tort Lawyer Blog &#8212; May 1, 2017<\/title>\n<meta name=\"description\" content=\"The U.S. Food and Drug Administration recently published a warning letter that it sent to St. Jude Medical, stating that the company likely downplayed the &#8212; May 1, 2017\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.molllawgroup.com\/blog\/fda-issues-warning-letter-st-jude-medical-regarding-defective-defibrillator-batteries\/\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:title\" content=\"FDA Issues Warning Letter to St. Jude Medical Regarding Defective Defibrillator Batteries &#8212; 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