Today we are extracting our 13th Riata due to inside out abrasion which caused the lead to fail. Rep from STJ continues to say there is nothing wrong....disgusting.....FDA, when ever you would like to step in, that would be great!
Publish or post the pictures and evidence to back up your claims. If you're not in a position to get it published, contact someone who is.
Barry Meier at the New York Times published a significant article on Guidant before their 2005-2006 issues. You could contact him. You can also read his article at http://www.nytimes.com/2005/05/24/business/24heart.html?pagewanted=all as an example of what he wrote. You can also contact the FDA if your center's complaints aren't being taken seriously by STJ. Provide them a list of lead models, serial numbers, copies of the documentation of the issues, and then they'll be at STJ writing them 483s.
If you have evidence that the defect rate is as high as you claim it to be, then you and your center need to man-up, come forward publically, and do something about it. St. Jude's published failure rates (http://www.sjmprofessional.com/Resources/product-performance-reports/Product-Performance-Report.aspx) are much lower than you indicate. There are over 150,000 Durata and Riata leads implanted so a bunch of people could be impacted if what you say is true. If you have evidence that they are at a greater risk than reported, it's your duty to raise the flag.
If you don't have evidence and are just repeating what you read off cafepharma, stop alarming patients.