FDA Medtronic Recall Updates | Medtronics Lawsuit News
Following the latest court decision involving preemption in the 
Medtronics lawsuit for the recalled Sprint Fidelis leads it is interesting to see the increasing number of reports regarding the inner-workings at the Food and Drug Administration. According to a recent New York Times article, nine government scientists complained to the FDA commissioner regarding FDA managers and their lenient relationship with corporations seeking approval for medical devices.
Internal documents and medical reviews reveal that the agency scientists were critical of the medical device approval process that they felt lacked adequate testing of medical devices. In one specific example, the scientists alleged that an agency supervisor pressured them to change reviews of a breast imaging device among others. The increasing information regarding the inability of the FDA to adequately evaluate medical devices such as the recalled Medtronic Sprint Fidelis leads and drugs is especially disturbing considering that the medical device and pharmaceutical industry has been using the FDA approval process as a shield from any liability for products that turn out to be dangerous.
Sprint Fidelis leads are manufactured by Medtronic, the medical device manufacturer headquartered in Minnesota. Medtronics leads consist of cardiac electrodes which are thin wires. These electrodes connect an implantable cardioverter-defibrillator (ICD) or cardiac resynchronization therapy defibrillator (CRT-D) to the heart.
The Sprint Fidelis leads recall was due to the potential for lead fractures. After reports of fractured leads and at least 5 patient deaths, Medtronic recalled their Sprint Fidelis leads. Patients may be at an increased risk of having their leads fracture or break. If this happens the defibrillator could deliver painful shocks or jolts or fail to operate at all.
We represent all Medtronic recall clients on a contingency basis which means that there are never any legal fees unless we win compensation in your case. For a free no-obligation consultation please call toll free at 1-888-343-5375 or fill out our short online contact form and a Medtronics lawsuit attorney will contact you to answer any of your questions.
We are a law firm dedicated to helping those injured by Medtronic Sprint Fidelis Defibrillator Lead.
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U.S. Food & Drug Administration Statement On Medtronic Sprint Fidelis Defibrillator
Medtronic Suspends Sprint Fidelis Defibrillation Leads (PDF)
U.S. FDA Class 1 Recall Report
If you or a loved one have been injured by the Medtronic Sprint Fidelis lead please contact us immediately. You may be entitled to compensation.
Some people who have been harmed by defective Medtronic leads have filed lawsuits against the manufacturer. But, before filing a Medtronic lead lawsuit, there are several things that you should know.
Which product is defective?
Medtronic Sprint Fidelis defibrillator leads were more prone to fracturing than previous generation models of leads. Defibrillators are implanted heart devices that [...]
Medtronic manufactured a type of heart defibrillator lead that had defective wires. The defective wires were “leads,” which connected the defibrillator to the heart. The leads would fracture, or break, on numerous defibrillators. The Medtronic lead fracture was deadly in some patients.
Which defibrillators were defective?
The Medtronic lead fracture would occur in the Medtronic Sprint Fidelis [...]
Medtronic has been has been involved in litigation for defective Sprint Fidelis heart defibrillator leads. These Medtronics lawsuits were initiated because the “leads,” which are wires that connect the defibrillator device to the heart, could break, causing serious injury, and even death in some patients.
How many defective leads were produced?
More than 268,000 Medtronic Sprint Fidelis [...]
If you are seeking Medtronic lawsuit dismissed 2010 information and news about the recall related to your internal cardioverter defibrillator, we can provide the necessary background, facts and resources you need.
Medtronic Defibrillator
Medtronic is a manufacturer of a variety of medical products, notably of the Medtronic defibrillator. The internal cardioverter defibrillator is a small computer that [...]
Patients across the country continue to file Medtronic Sprint Fidelis lawsuit claims spurred by lead recall of the Sprint Fidelis wires. As patients face long-term side effects from the faulty defibrillator wires, they seek compensation from the company they believe knew of the wire problems long before the recall was issued.
A defibrillator is a life-saving [...]
