St. Jude Promises Improvements To Correct Defibrillator Lead Problems
St. Jude Medical has acknowledged that there were manufacturing deficiencies involving its controversial defibrillator leads, and is promising federal regulators that it will make improvements to correct the problems.
In a letter sent in response to a recent FDA inspection, which was obtained by the Wall Street Journal, St. Jude admitted there were quality control problems and said it will address a number of deficiencies found by FDA inspectors.
The inspections occurred at a St. Jude’s production plant in Sylmar, California, coming in the wake of a a Riata and Riata ST defibrillator lead recall issued in late 2011.
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St. Jude Riata leads were removed from the market after repeated reports of problems where the small wires, which are used to connect implantable cardioverter defibrillators (ICD) to the heart, were poking through the insulating material, resulting in exposed wires inside of some patients. This may lead to unnecessary shocks or cause the ICD to fail to deliver a life-saving jolt when needed. As a result of the problems, a number of patients have had to undergo risky surgery to remove and replace the lead wires.
A growing number of individuals throughout the United States are now pursuing a St. Jude Riata product liability lawsuit, alleging that manufacturing defects made the insulation weaker at certain points, allowing the wire to penetrate and become exposed inside the body.
In 2006, St. Jude introduced a new line of leads, known as Riata ST Optim, with a redesigned insulating material. After concerns arose within the medical community over the original Riata design, the newer leads were renamed the St. Jude Durata in 2008.
Although St. Jude has tried to shield its Durata leads from the fallout surrounding its recall of Riata and Riata ST defibrillator leads, some concerns have been raised that suggest there may also be a risk of problems caused by the manufacturing processes with the Durata leads.
FDA Inspection Found Numerous Manufacturing Deficiencies
The original FDA investigation report, which was released by the agency in November 2012, outlined a number of concerns over manufacturing deficiencies where the St. Jude Durata defibrillator leads are made.
The inspection report found that St. Jude failed to adequately test design changes made to the Durata leads following the Riata recall. Among the 11 different deficiencies cited in the inspection, investigators found problems with design verification and validation, how the company responded to complaints, and noted that lead design elements were tested only once, even though the company’s own protocols called for five tests.
In the manufacturer’s response, the Wall Street Journal reports that St. Jude has committed to improving training and quality control procedures at its Sylmar facility, and says it will take specific steps to address FDA concerns.
Last month, a St. Jude class action lawsuit was filed by investors over the problems with the defibrillator leads, alleging that the company perpetrated fraud and misled investors about the safety of the Durata leads, resulting in inflated stock value.
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