FYI...

Somebody let Don Foreman know about this posting as he may find it of
interest...I think he might have me killfiled yet as a dangerous
liberal minded threat. ;)

TMT

March 14, 2009
Medtronic Links Device for Heart to 13 Deaths
By BARRY MEIER

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.