The fraying of the Durata Lead in St. Jude Medical Inc.’s Durata Lead Wire has raised serious concerns over the health complications related to this defect that has injured one patient so far. Used as a connection device for the internal defibrillator and the heart, the Durata Lead has reportedly been deemed potentially dangerous for those who have received the implant. The exposure of the wire through its insulation is what has led to the fraying of the Durata Lead.
As of today only one patient has suffered as a direct result of the medical device defect, however, if the fraying continues for other patients, they are at risk due to the exposure of the wiring. This exposure may cause the implantable defibrillator to emit shocks at inappropriate times or even fail to emit necessary shocks.
Serious health complications may ensure for any patients who have experienced shock emission failure or emission of shocks at inappropriate times. Any patient who has received the Durata Lead implant as well as the internal defibrillator is at risk of death caused by the defective device.
Mike Lewis Attorneys is currently taking on Durata Lead cases throughout the state of North Carolina. Any patient who has experienced any health complications as a direct result of this product may be entitled to compensation for their suffering. If you or a loved one has endured any health issues from the a failure or error of the internal defibrillator linked to the St. Jude Durata Lead, our class action lawyers are prepared to take your case today.
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St. Jude Durata Lead Wire Information
Originally introduced to replace the Riata Leads, the St. Jude was thought to be the device of choice today. Riata Leads stopped selling their devices in December of 2010 and recalled the product entirely following reports that indicates a penetration of the wires in the insulation. To address this issue, the Durata Leads were produced to prevent this fraying with a special insulation coating called Optim.
In June of 2012, the U.S. Food and Drug Administration (FDA) were informed that a patient found fraying of the Durata Lead Wire. According to the report, “Noninvasive programmed stimulation of ICD, revealed undersensing of ventricular fibrillation after induction. Fluoroscopy of lead revealed externalization of conductors. The externalization was confirmed at lead extraction. The externalization was adjacent to the distal coil of the lead.”
The FDA report was filed on April 18, 2012 and raised widespread concerns over the clear similarities between the newly released Durata Lead Wire and the previously recalled Riata Leads. On top of these concerns, these reports highlighted the smaller diameter of St. Jude’s Lead Wires compared to more reliable leads that were on the market.
Following an FDA inspection of St. Jude manufacturing plants, 11 issues were raised concerning the risks linked to Durata Lead Wires. Of the 11 issues, the FDA stated that 5 of the company’s responses were inadequate. The FDA quickly discovered that the products were tested only once, while the testing requirements clearly outline a requirement of at least 5 tests.
Contact a Knowledgeable Class Action Attorney Now
With office locations in Greensboro and Winston-Salem, NC our class action lawyers can provide many years of combined legal experience to our clients, and have a consistent, proven record of excellence. We have the knowledge and resources to handle your class action lawsuit, and can help to guide you through the entire litigation process.
Mike Lewis Attorneys has dedicated their practice to helping North Carolina residents to achieve justice. When the wrongdoings of a company produce an unsafe product, the manufacturer of the medical device must be held liable for the negligence. If you or a loved one has been injured due to the St. Jude Durata Lead, our defective device lawyers are here for you.
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