St. Jude Medical Inc.’s Durata Lead Wire has reportedly caused serious health complications due to the fraying of the Durata Lead in at least one patient thus far. The Durata Lead is used as a connection device for the internal defibrillator and the heart. The St. Jude Durata Lead frayed due to the exposure of the wire through its insulation. While only one patient has suffered as of today, if other Durata Leads undergo a comparable fraying defect, there is great risk in the exposure of wiring that may cause shocks to be emitted at inappropriate times or fail to emit shocks when needed from the implantable defibrillator.
Any patients who experienced an inappropriate emission of shock or lacks emission when necessary are subject to a number of serious health risks. Patients who have had Durata Leads implanted in addition to the internal defibrillator are at risk of death due to this defective product.
The Eichholz Law Firm is currently taking all cases for those patients who have experienced health issues after receiving Durata Leads. If you or a loved one has experienced a error or failure of an internal defibrillator that may be linked to the defective St. Jude Durata Lead Wire, our defective product attorneys are here for you.
To learn more about your legal options, please complete a Free Case Review form on this page.
St. Jude Durata Lead Wire Information
St. Jude first introduced the Durata Lead Wire to replace Riata Leads, another controversial product. When they ceased the sale of Riata Leads in December of 2010 they recalled them just a year later following reports indicating a penetration of their wires in the insulation. As a result, the Durata Lead was introduced which used a special insulation coating, Optim, to supposedly prevent this fraying from occurring.
The U.S. Food and Drug Administration (FDA) then received notice in June of 2012 that a physician reportedly found fraying in a patient who had a Durata Lead Wire. The report to the FDA stated the following, “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.”
Following this report, which was outlined the incident which had taken place on April 18, 2012, concerns were raised regarding the similarities in product defects between the recalled Riata Leads and the newly released Durata Lead Wire. In addition, concerns were raised regarding the smaller diameter of the St. Jude’s leads compared to other available leads that may have been more reliable.
The FDA’s inspection of St. Jude’s manufacturing plants revealed 11 issues connected to the Durata Lead Wire. The FDA has stated that St. Jude’s response to 5 of these 11 problems were inadequate. More specifically, the FDA discovered that they leads were all only tested once, contrary to the testing requirement which states that they should have been tested at least five times.
Contact an Experienced Defective Product Lawyer Today
The Eichholz Law Firm is currently seeking to help those patients who have received St. Jude Durata Lead Wires. With years of experience in defective product litigation, our Georgia Durata Lead Wire attorneys are prepared to fight for the compensation that these suffering patients deserve.
Combining years of legal work, an extensive knowledge of the law, and a compassion for people, the legal staff of the Eichholz Law Firm has helped countless individuals seek the compensation that they deserve. If you or a loved one has suffered due to the Durata Lead Wire, our GA defective product lawyers are prepared to take your case today.
For more information, please fill out a Free Case Review form above.