Medtronic said Friday that at least 13 people might have died in connection with a heart device that it recalled in 2007 but was still in widespread use, including four patients whose deaths were related to efforts by doctors to surgically remove the product.
The new data reflect the first fatality update by Medtronic since October 2007, when it recalled the device — a thin electrical cable that connects an implanted defibrillator to a patient’s heart. The company cited five deaths when it recalled the product, saying fractures in the cable could cause a defibrillator to fail to deliver a lifesaving shock to an erratically beating heart, or to fire for no reason.
Separately, a previously undisclosed Food and Drug Administration report indicates that Medtronic began receiving reports soon after the device reached the market in late 2004 that the cable, known as the Sprint Fidelis, was fracturing. The company also revised its manufacturing process in the months before withdrawing the Sprint Fidelis from the market, according to the F.D.A. report, which was provided to The New York Times by lawyers suing Medtronic.
A top Medtronic official said in an interview on Friday that the manufacturing change in question was unrelated to the reasons for the recall and that even at the time of the recall internal data did not suggest it was fracturing at a significantly higher rate than other company leads.
When Medtronic may have known the Sprint Fidelis posed safety problems, and how it responded to that information, could be significant factors if patient lawsuits over the product were to start moving forward again. This month, top Democratic lawmakers introduced legislation that would effectively nullify a Supreme Court decision last year that has blocked lawsuits against medical device makers like Medtronic. The company recently said that about 2,000 legal claims involving the Sprint Fidelis had been filed against it.
The death statistics Medtronic released Friday underscore both the scope of the Sprint Fidelis problem and the difficult choices that doctors and patients face in deciding what to do about it. About 150,000 people in this country still have the Sprint Fidelis leads in their bodies.
Along with fatalities, the F.D.A. has received about 2,200 reports of serious injuries related to the leads. Medtronic officials said they believed that reflected the number of people who had undergone surgery to have a failed lead replaced with a new one.
Dr. David Steinhaus, Medtronic’s medical director, said the updated figures, which the company distributed Friday to doctors, was based on a review of available data by company officials and a panel of five outside physicians.
He said that the outside panel was particularly concerned with the four deaths related to surgical efforts to remove the lead.
Doctors often choose to leave a fractured heart device lead in place when implanting a new one. In the advisory to physicians on Friday, the panel urged that doctors who think a patient would benefit from having a failed lead extracted have the procedure performed by a physician skilled in doing so.
“If you are going to have it done, you ought to go to a place where they are doing a lot of them,” Dr. Steinhaus said.
Besides the deaths related to the surgeries, the panel appears to have concluded that the nine other deaths may have been tied to the device’s failure to function properly.
The F.D.A. report is based on a visit by regulators to a Medtronic facility in Mounds View, Minn., soon after the device was removed from the market, where the officials interviewed executives and inspected records.
The report shows that by late 2005 the company had received 30 complaints about device fractures and had identified several possible ways in which the lead might be failing. About that time, the company opened an internal investigation into the problem, according to the report.
What happened next is not clear, because the F.D.A. redacted portions of the report before releasing it. But the document indicates that Medtronic engineers met often about the problem throughout 2006 and that they performed a “statistical analysis of the three failure modes” of the lead in October of that year, the report states.
It was in February 2007 that Dr. Robert G. Hauser, a cardiologist at the Minneapolis Heart Institute, met with Medtronic officials and informed them that his database of heart patients showed that the Sprint Fidelis was fracturing at a troubling rate. In a telephone interview this week, Dr. Hauser said Medtronic officials said nothing to him then about the company’s internal investigation.
Asked to respond Friday, Medtronic issued a statement saying that fractures of heart device leads were not unusual and that at the time of the Hauser meeting it “had no data to demonstrate that there was a statistically significance difference” in failure rates between the Sprint Fidelis and the company’s other leads.
Soon after meeting with Dr. Hauser, Medtronic sent a letter in March 2007 to doctors informing them of his data and saying it was investigating the issue. Two months later, Medtronic took steps to change how it manufactured the Sprint Fidelis, the F.D.A. report shows.
Tim Samsel, the company’s vice president for quality and regulatory, said in a telephone interview that the manufacturing change was intended to address “acute” lead fractures at the time of implant, not the chronic fractures that eventually led Medtronic to recall the device.
Between the company’s meeting with Dr. Hauser and its recall of the Sprint Fidelis, it is estimated that tens of thousands of additional patients received the device.
Asked this week to review the F.D.A. report, Dr. William H. Maisel, a cardiologist at Beth Israel Deaconess Medical Center in Boston, said it suggested that Medtronic long knew there were issues with the Sprint Fidelis.
“In 2006, the company recognized there was a problem,” said Dr. Maisel, who has been critical of Medtronic’s handling of the lead.
Source: New York Times