AN UPDATED REPORT 2009 ABOUTPROBLEMS WITH THE MEDTRONIC SPRINT FIDELIS IMPLANTABLE DEFIBRILLATOR AND A VIDEO UPDATE WHAT IS IT

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Watch a Video About Medtronic Implantable Defibrillator

Here is an update and elaboration (in 2009) to a story about problems with the Medtronic Implantable Heart Defibrillator which were originally announced in 2007. "Medtronic said Friday that at least 13 people might have died in connection with a heart device that it recalled in 2007 but was still in widespread use, including four patients whose deaths were related to efforts by doctors to surgically remove the product". The defibrillators are tiny impanted devices that can monitor the heart rhythm. When they detect a dangerous heart rhythm that could cause cardiac arrest the defibrillator delivers a jolt of electricty to correct the problem.




The scientific marvel, implantable defibrillators are helping many ( former Vice President Cheney has one). But like many things in life, problems can arise. It's been a while 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.



"Along with fatalities, the F.D.A. has received about 2,200 reports of serious injuries related to the leads. Medtronic officials said they believed that reflected the number of people who had undergone surgery to have a failed lead replaced with a new one. Dr. David Steinhaus, Medtronic’s medical director, said the updated figures, which the company distributed Friday to doctors, was based on a review of available data by company officials and a panel of five outside physicians".

Medtronic Links Device For Heart To 13 Deaths
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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