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: Maryland Injury Lawyer Blog

New ICD Technologies

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In an article published Wednesday in the New England Journal of Medicine, the cardiologist who sounded an early alarm on the later recalled Medtronic Sprint Fidelis leads warns that a soon-to-be-approved electrical component for implantable heart devices may prove dangerous to patients.

Dr. Robert G. Hauser of the Minneapolis Heart Institute argues that manufacturers and federal regulators have not adequately tested the new defibrillator connections, or leads, for potential short-circuiting problems. Like the Medtronic Sprint Fidelis leads, this new technology is viewed by the FDA as a change of an existing product and so does not require the same degree of testing that is required for a new product.

Full post as published by Maryland Injury Lawyer Blog on December 12, 2008 (boomark / email).

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