“The hazard of [Sprint] Fidelis lead fracture is increasing exponentially with time and, based on our data, occurring at a higher rate than the latest manufacturer’s performance update,” doctors at the University of Rochester concluded in findings published in the January 2010 issue of the American Journal of Cardiology [abstract only]. The study found that the three-year survival rate of 426 Medtronic leads inserted in the hospital’s patients was 90.8%, meaning 9.2% failed. This follows a report from December 2009 which estimated the failure rate of the Sprint Fidelis lead may eventually reach 30% of all patients.
On February 4, 2010, the Wall Street Journal noted that the FDA database includes at least 12 additional deaths allegedly linked to the recalled device [login required].
I think in order for these death rates to go down, these big medical device companies need to be held liable for the problems they are causing not only to these people but their families also. It can not be that hard to do a good quality check and ensure all devices are working properly, so they are not causing people more health problems or killing them.
It is time for the government to put their foot down pass this bill so these companies can be held liable for their mistakes. Vote Yes, to pass this fabulous bill!
We agree —Please pass the bill making Medtronic responsible for their mistakes
Thank you!!!! 1000 times!!!
The info is greatly aprreciated. It is sometimes hard to keep up with all the recalls out there. Your website is another good source that I will add and check from now on for updates. Keep up the good work.
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