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Guidant Pacemaker | Defibrillator Recall News Article |
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| June
2, 2005 |
The
New York Times, "Heart Device
Sold Despite Flaw, Data Shows" |
When
the Guidant Corporation told doctors last week
that a popular implantable heart defibrillator
had failed in a small number of cases because
of an electrical flaw, it also said that it
had fixed the flaw in devices produced after
mid-2002.
But now data provided
by Guidant to a Minnesota hospital suggests that the company continued to sell
the potentially flawed devices for months after it changed the way it made the
device and had begun selling the new ones.
The Guidant data, which
the company provided to doctors at Abbott Northwestern Hospital in Minneapolis,
indicates that from May to September 2002, nine patients there received implants
of defibrillators that were made before April 2002.
It was during that month
that the company first changed its manufacturing process to eliminate the risk
of short-circuiting. A senior company official has said that Guidant to date
has not received reports of such failures in units made after April 2002.
A defibrillator, which
is implanted under the skin in the chest, acts to shock a chaotically beating
heart back into normal rhythm. The device at issue is known as the Ventak Prizm
2 DR Model 1861, or alternatively as the Prizm 2 DR.
Last week, Guidant, which
is based in Indianapolis, told doctors and patients for the first time that the
defibrillator failed because of the short-circuiting problem seen in 26 known
cases, including one recent death. About 37,000 such units were made before Guidant
made the April 2002 fix. An estimated 24,000 people still use one of those units.
The apparent fact that
Guidant sold older devices with the potential flaw when improved ones were available
could pose a new round of problems for the company. The Food and Drug Administration
is reviewing how Guidant officials handled problems related to the device.
In addition, two plaintiffs'
law firms filed an action yesterday against Guidant in Federal District Court
in Indianapolis seeking damages in connection with the company's handling of
the device. Guidant has previously said that it did nothing wrong. |
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Heimann & Bernstein, LLP is an over-sixty-attorney
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