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St. Jude Durata Lead Injury

St. Jude Durata Lead Injury Lawyer |St. Jude Defibrillator Side Effects Lawsuits | Side Effects: Cardiac Tamponade Perforates Heart Tissue, Heart Damage, Irregular Beating | Defective Lead Wires, Perforation Problems
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St. Jude Durata Lead Injury Lawsuit Lawyer

St. Jude Durata Lead Injury 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).


St. Jude Durata Lead InjuryRSS Feed

St. Jude Medical's Riata Lead Externalization Linked to Electrical Failures, Study Finds

Aug 13, 2014
The findings of a Danish study suggest that “lead externalizations” with St. Jude Medical’s recalled Riata and Riata ST defibrillator leads are associated with electrical failures and gets worse over time. Lead externalization is a problem where the lead wires of the device pokes through the insulation; this defect is what prompted the recall in the first place, according to Mass Device. Heart Rhythm published the study, titled "Prospective Nationwide Fluoroscopic and...

FDA Issues Stronger St. Jude Durata Warning

Jan 16, 2013
The U.S. Food & Drug Administration just issued an even stronger warning to St. Jude Medical about its Durata electrical heart lead. The stern warning, issued yesterday, threatened to either impose a fine or take other actions against St. Jude Medical for neglecting to respond to the federal regulator’s concerns about the heart device, said The New York Times. In 2011, St. Jude issued a Class I recall on its Riata and Riata ST cardiac defibrillator leads after they were associated...

Leading cardiologist urges caution with new leadless defibrillator devices

Jan 3, 2013
A leading and outspoken cardiologist is again urging caution on the use of a new implanted cardiac defibrillator device. According to a Reuters report this week, Dr. Robert Hauser writes in the most recent edition of Journal of the American College of Cardiology that Boston Scientific's new cardiac defibrillator device that does not use lead wire technologies to deliver shocks to a recipient's heart, a device known as a subcutaneous implantable cardioverter-defibrillator (S-ICD). Boston...

St. Jude Medical's reputation in the balance amid Riata, Durata scandals

Nov 27, 2012
What is the name of the medical device blacked out in a recent federal report made public by St. Jude Medical, one of the leading companies in the industry. Speculation abounds, according to a New York Times report, on which product is redacted from a recent federal report on the medical device company. It could be one of its embattled implanted cardiac defibrillator lead wires, the Riata or the Durata, or it could be another device altogether. Whichever it is, the damage is already underway...

Speculation over Durata lead safety grows following inspection report, new study

Nov 26, 2012
A newly-released inspection report at St. Jude Medical along with the results of a new study funded in large part by the company's chief competition has raised more speculation over the safety of the St. Jude Durata cardiac defibrillator leads. According to a New York Times report this week, Medtronic Inc. has released the results of a new study it conducted on the material St. Jude uses as an allegedly new and improved insulated coating that protects the conductive end of the delicate medical...

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