St. Jude Durata Lead Injury
St. Jude Durata Lead Injury Lawsuit Lawyer
St. Jude Medical Inc.'s Durata Lead Wire, which is used to connect an internal defibrillator to the heart, is raising concerns following a report that a Durata Lead frayed in at least one patient. The fraying of the St. Jude Durata Lead resulted in the wire becoming exposed through its insulation. If other Durata Leads suffer from a similar fraying defect, there is a risk that exposed wires could cause an implantable defibrillator to emit shocks at inappropriate times, or fail to do so when necessary. Either scenario could result in serious injury or death of patients who have had Durata Leads implanted along with an internal defibrillator.
The defective medical device lawyers at Parker Waichman LLP are investigating possible fraying defects associated with the St. Jude Durata Lead. If you or someone you love experienced a malfunction of an internal defibrillator that could be associated with a defective Durata Lead Wire, we would like to hear from you. For a free, no obligation Durata Lead lawsuit evaluation with one of our experienced medical device attorneys, please call 1 800 YOURLAWYER (1-800-968-7529) today.
St. Jude Durata Lead Fraying Report
The Durata Lead Wire was introduced by St. Jude as a replacement for its controversial Riata Leads. St. Jude stopped selling Riata Leads in December 2010, and recalled them a year later, after the company received reports of the wires penetrating their the insulation. When the Riata Leads were officially recalled in December 2011, at least two patient deaths had been attributed to the defect. The Durata Lead was made with a new type of insulation coating, called Optim, which was supposed to prevent fraying.
In June 2012, it was learned that a physician had reported to the U.S. Food & Drug Administration that a Durata Lead Wire had frayed in a patient. "Non invasive programmed stimulation of ICD, revealed undersensing of ventricular fibrillation after induction," the report stated. "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." According to the report, the incident occurred on April 18, 2012. No other details were given.
The report has sparked concern that the Durata Lead Wire could suffer from the same problems that resulted in the Riata Lead recall. It also raised questions about the use of St. Jude’s smaller diameter leads should be used when other more reliable leads are available.
Legal Help for Victims of the St. Jude Durata Defibrillator Lead Wires
If you or a loved one sustained an injury that could be related to a frayed St. Jude Durata Lead Wire, you may have valuable legal rights. For a free, no obligation lawsuit evaluation with one of the experienced medical device lawyers at Parker Waichman LLP, please fill out our online form, or call 1-800-YOURLAWYER (1-800-968-7529).