Recent reports have raised concerns about St. Jude Medical Inc.s Durata Lead Wire which have caused serious health complications in at least one patient due to the fraying of the Durata Lead Wire. Used as a connective device for the internal defibrillator and the heart, the fraying of the Durata Lead Wire those who have received the device are warned to be aware of any injuries that could be related to the defective product. Reports indicate that the fraying of the Durata Lead Wire occurred due to exposure through its insulation.
As of today only one patient have reportedly suffered due to the defect, however, it is important for all Arizona residents who have received this device to exercise extreme caution. While a number of risks are hazardous if fraying occurs, the most notable include failure to emit shocks when they are needed from the implantable defibrillator or the emission of shocks at inappropriate times. Both of these reactions are incredibly dangerous for any patient who has a Durata Lead Wire implanted. Patients who experience any problems with the Durata Lead Wire are at risk of serious health complications, even death.
Phillips Law Group represents Arizona residents throughout the country who have suffered due to a defective medical device. Patients trust that the manufacturers of these products are meticulous and thorough in the development of these devices. When they fail or maintain some type of defect, the manufacturer must be held liable. If you or a loved one has suffered due to an error or failure of the defective St. Jude Durata Lead Wire, our Phoenix defective device attorneys are here to help.
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St. Jude Durata Lead Wire Update
St. Just Medical Inc. first brought the Durata Lead Wire to market to replace the controversial Riata Leads, which had sustained severe backlash from the public and the FDA. In December 2010, the sale of Riata Leads had stopped and the product was recalled a year later due to the penetration of wires in the insulation. Durata Lead Wire was then introduced as an alternative that contrasted to Riata with their use of Optim, a special insulation coating that was supposed to prevent fraying.
In June 2012, the U.S. Food and Drug Administration (FDA) were given notice that the Durata Lead Wire had frayed in at least one patient. The FDA report revealed this statement, 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 patient experienced health issues due to the fraying of the device on April 18, 2012, which highlighted the connection between the Durata Lead Wire and the recalled Riata Leads. Even further, the smaller diameter of the St. Judes leads raised additional concerns, as the reliability of these leads was questioned when compared to similar leads on the market.
Following an inspection of St. Judes manufacturing plants; the FDA raised 11 issues related to the Durata Lead Wire. St. Judes replies to 5 of these 11 issues were deemed inadequate. Finally, it was revealed that St. Jude had tested the devices only once, while the requirement states that all leads should be tested at least five times.
Contact a Knowledgeable Defective Medical Device Attorney Today
Patients place an abundance of trust in the physicians that care for them. In turn, the physicians that care for these patients trust that the manufacturers of medical devices are developed with the most optimal detail and compliance. Unfortunately, many medical devices released to the public today are not thoroughly tested and therefore dangerous to those who are treated with them.
Phillips Law Group has years of experience in defective product litigation. Our experienced Phoenix personal injury lawyers understand what it takes to build a successful case that awards our clients the compensation that they deserve. If you or a loved one has suffered following the use of a Durata Lead Wire, our St. Jude Durata Lead Injury lawyers are here for you.
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