MEDTRONIC SPRINT FIDELIS IMPLANTABLE DEFIBRILLATOR VIDEO UPDATE AND WHAT IS IT
Watch a Video About Medtronic Implantable Defibrillator
The scientific marvel, implantable defibrillators are helping many (Vice President Cheney has one). But like many things in life, problems can arise. It's now been six months since Medtronic's recall of their 7-French Model 6949 Sprint Fidelis defibrillator lead in October 2007. Medtronic had announced that "We have found that there is a small chance of fractures in particular locations on the Sprint Fidelis lead" of the Medtronic defibrillator. What is the lead? "The wire that connects the heart to a defibrillator, a device that shocks faltering hearts back into normal rhythm. The company urged all of the estimated 235,000 patients with the Fidelis, to see their doctors to make sure it has not developed a fracture that can make the device to misread heart-rhythm data.
Video from the FDA About Sprint Fidelis Recall Click the Arrow to Start
According to the blog of a prominent cardiologist "The first update of the Sprint Fidelis lead performance arrived in my office this week, dated 7 May 2008 . With this letter came the first trending data of the failure rates as determined by evaluation of Medtronic's Carelink follow-up database and Returned Product Analysis reports as well".
"While the number of lead failures remains relatively small and current follow-up recommendations have not changed, the failure trends, albeit early, remain concerning. It appears that a continued number of failures throughout the life of the lead can be expected. By Medtronic's analysis of a typical 1,000-patient ICD clinic, over the next 12 months, nine (9) patients can be expected to have an anode or cathode failure and half of those patient's will have little warning of an impending fracture".
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