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Lawsuit Alleges PTSD Due to Recall

admin — Wed, 20 Feb 2008 15:13:02 +0000

In a lawsuit filed in Marshall, Texas, a man alleges the anxiety he experienced after the recall of Sprint Fidelis leads by Medtronic lead him to have Post Traumatic Stress Disorder (PTSD) and to seek a psychiatrist. He also claims that he has experienced multiple unnecessary shocks from his defibrillator that can only be attributable to the leads.

The man underwent emergency surgery to replace the defective leads in his defibrillator but has still experienced stress. He feels that he is at a heightened risk of cardiovascular events or even death. He also believes that he will continue to undergo severe physical injuries and or death, sever emotional distress, economic losses, and consequential damages, even after the defective leads were replaced.

If you or someone you know has experienced unnecessary shocks from a Medtronic defibrillator that has Sprint Fidelis leads, contact the Medtronic lawsuit attorneys of Williams Kherkher at 1-866-950-9000 to discuss your case and to schedule an initial consultation.

Medtronic Sparks Congressional Inquiry

admin — Wed, 07 Nov 2007 19:29:47 +0000

The Medtronic recall of their Sprint Fidelis leads has sparked an investigation by Congress into the processes the FDA uses to approve implantable medical devices. It is being undertaken by the House of Representatives Oversight and Government Reform Committee.

Last month, Medtronic recalled their defibrillators feature Sprint Fidelis leads after they determined the leads had broken and lead to death in 5 patients. The company had apparently known about the problem of breaking leads for months and done nothing about it prior to October.

Congress feels the inquiry is necessary once it was reviewed that the FDA does not require extensive testing of the vital defibrillator component before goes on the market. The FDA had required that Medtronic test extensively a previous edition of their leads but not on this one as it was just an improvement of a prior product and not a brand new product. The FDA’s tests only required that the leads undergo stress tests that imitate pressures that are similar to those the body would place on the leads. These tests mainly are there to catch design flaws. The FDA is confused as to why the stress tests did not catch the problem of breaking leads.

If you or someone you know has been implanted with a Medtronic defibrillator, contact the Medtronic Lawyers of Williams Kherkher at 1-866-950-9000 to set up a consultation.

Medtronic Shown to Drag Feet on Removing Product from Market

admin — Tue, 30 Oct 2007 21:48:25 +0000

Medtronic was shown to have known for months that its Spirit Fidelis Defibrillator Leads were fracturing at higher-than-normal rates for months and yet took their own sweet time pulling the product from the market. They even went so far as to blame physicians for the defects rather than accept responsibility. The FDA, which did not require the device to undergo clinical testing, was clueless as this went on for months as well.

When a lead (which is a sensor that extends into the heart) breaks, it can emit a massive and painful shock that can cause death. According to the WallStreet Journal, 286,000 defective Sprint Fidelis Leads have been implanted worldwide since the product went on the market in 2004 to replace the Sprint Quattro leads.

If you or someone you know has been impacted by the Sprint Fidelis Leads by Medtronic, contact the medtronic lawyers of Williams Kherkher in Houston.