The Food and Drug Administration (FDA) has recently received a report of a St. Jude Durata cardiac defibrillator lead wire breaking free of its insulation, a potentially dangerous and life-threatening defect that had been the demise of previous models of these medical devices.
According to a Bloomberg report this week, a physician anonymously reported the defect to the FDA and not St. Jude Medical Inc. on April 17. Although the means by which this defect was reported is being questioned by some, if it is confirmed as fact it would be the first known event in which a conductive end on a Durata lead wire had broken free of its silicone housing, exposing the wire it contains.
The Durata is designed to connect an implanted cardiac defibrillator to the heart and delivers life-saving jolts that either keep a heart beating or regulate the heart rhythm.
St. Jude introduced the Durata lead after failings of its previous device, the Riata. The Riata model of leads were removed from the market after too many reports of defects associated with it. The Riata has been associated with a high rate of failure, specifically reports of the conductive ends breaking free and either not delivering shocks at the right time or failing to deliver shocks. The exposed ends have also been linked to internal injuries like lacerations.
An inferior housing on the Riata leads was eventually blamed for the large number of reported defects and it was changed to a silicone material known as Optim and released as the Durata lead.
In recent months, St. Jude involved itself in a bitter argument over the results of a study which linked the Riata leads to more patient deaths than the company believed it had caused and attempted to present its own data on the device’s safety.
The company was not notified of the adverse event report until it was posted on the FDA’s Maude database, the Bloomberg report indicates. Experts interviewed by the source say it is rare for an adverse event report with as many specific details as contained in this one to be submitted in this means and that the agency and medical device firm are both investigating it further.
The physician’s report to the database reportedly did not include details such as the Serial number of the device, the name of the physician, or the hospital where it was collected.
An analyst told Bloomberg that although this is an isolated incident, more reports of Durata failures could indicate deficiencies with thinner cardiac defibrillator leads compared to older models which were not associated with similar adverse event complaints.