New Problems with Cardiac Defibrillator Leads Reported

Today’s edition of the NY Times provides insight to a problem most healthcare professionals believed had been solved after a slew of civil lawsuits against the manufacturer of the Guidant defibrillator leads had been resolved. One of the keys to resolution of the failed Guidant defibrillator leads was a promise made by defibrillator lead manufacturers concerning monitoring and reporting of safety concerns concerning the proper functioning of the leads.
Now, however, the Times article notes that new concerns have arisen over St. Jude Medical’s Riatta defibrillator leads.
The Times reports, “Last month, an outside researcher, Dr. Robert Hauser of Minneapolis, released a study indicating that short-circuits and other failures of the St. Jude lead might have played a role in some 20 patient deaths.
His report followed several studies showing that the lead, called the Riata, was also prone to another malfunction, a tendency for internal wires to break through the protective outer coating and cause electrical problems like unintended shocks in some patients. An estimated 128,000 patients worldwide still use the Riata lead, which the company stopped selling in late 2010.
St. Jude executives, including the chief executive, Daniel J. Starks, quickly reacted to Dr. Hauser’s report by unleashing a public relations campaign aimed at discrediting the study’s accuracy and Dr. Hauser. But left unanswered amid the noise was the question: how closely had St. Jude been examining those deaths for signs pointing to a broader problem involving the Riata lead?
“Someone in the company should have been watching this,” said Dr. Robert J, Myerburg, who led an independent investigation into Guidant’s decision not to warn doctors that some of its defibrillators could short-circuit. A defibrillator emits an electrical jolt to interrupt a potentially fatal heart rhythm and restore the normal heartbeat. ”