Bloomberg - January 13,
2006
...Guidant Corp. reduced training and emphasized production speed over
quality at its troubled factory making implantable heart devices in St.
Paul, Minnesota, according to a 14-year worker who trained others there.
Management set "unrealistic" goals for production of pacemakers and
defibrillators and offered incentives for meeting them...
New York Attorney General Sues Defibrillator Maker; Spitzer alleges defect
in Guidant's life-saving defibrillators
USA Today - November 3, 2005
Guidant (GDT) shares fell Thursday after New York Attorney
General Eliot Spitzer accused the company of failing to inform physicians
about a potentially fatal mechanical flaw in some of its surgically
implanted heart defibrillators. "We wouldn't permit this type of conduct in
connection with the sale of cars or washing machines," Spitzer said. "It is
simply unconscionable that it occurred with a critical medical device."
FDA: Defibrillator defects on the rise
CNN - September 16, 2005
Malfunctions in implanted heart defibrillators were on the rise even
before this summer's massive recall by Guidant Corp., government and Harvard
University scientists reported Friday. About 20 of every 1,000
defibrillators implanted are malfunctioning, and defects led to 31 deaths
between 1990 and 2002, concluded research sponsored by the Food and Drug
Administration.
F.D.A.
Expanding Inquiry Into Heart-Device Company
New York Times - August 25, 2005
The Food and Drug Administration said yesterday that it would conduct
an extensive inspection of the manufacturing facilities of the Guidant
Corporation, a maker of implantable heart devices that is under scrutiny for
the way it disclosed product problems.
Implant Recalls Heighten Anxiety
Pittsburgh Post-Gazette - August 21, 2005
... Guidant knew of risks ... But the scrutiny of Guidant and other
defibrillator makers may be just getting under way. In May, the New York
Times said the Indianapolis corporation sold a defibrillator model it knew
had a small risk of malfunctioning, but didn't issue warnings about it for
three years.
Guidant
braces for legal battle
Minneapolis Star-Tribune - August 16, 2005
... Many of these lawsuits were filed by patients like (Daniel) Flynn who
believe the Indianapolis-based company hid important safety information
about the devices. Others were filed on behalf of investors who saw the
value of their shares decline as the bad news continued to dribble out early
this summer.
Patients
with defibrillators face tough choice
USA Today - August 11, 2005
... Patients recently learned that their pager-sized ICDs had a rare flaw
that could cause them to short-circuit and fail just when they might need
them to save their lives.
Problems
with heart device raise questions
St. Petersburg Times - August 7, 2005
... A group is debating how soon doctors should be notified when flaws are
reported.
Heart
implants raise questions as their use soars
International Herald Tribune; New York Times - August
3, 2005
... A little-known heart device, an implantable defibrillator, has been
under the spotlight since a recent disclosure that a manufacturer, Guidant,
did not tell doctors for years that one of its models had a defect that
could render it useless.
Guidant
And FDA Could Face Senate Scrutiny
WCCO.COM - July 31, 2005
... Sen. Charles Grassley, R-Iowa, chairman of the Senate Finance Committee,
asked the FDA to provide documents relating to Guidant's series of recalls.
New
Report of Problems at Guidant
New York Times - July 30, 2005
... A filing, which was first publicly disclosed earlier this month, shows
that a heart patient implanted with a specific type of Guidant unit
"presented to a hospital" around the beginning of March after
suffering cardiac arrest, an often fatal condition that the device known as
a defibrillator is intended to prevent. This happened two weeks before a
college student with a flawed heart device died in March.
As Many As 69 Pacemaker Models May Have Failed; Two Deaths and Dozens of
Product Failures Led to Recalls
Consumer Reports - July 26, 2005
... On July 22, the Food and Drug Administration classified Guidant's recall
as Class I, the most serious kind. As many as 69 pacemakers may have failed
according to Guidant. All the reported failures occurred in devices that had
been implanted in patients for at least 44 months.
Guidant Says Defibrillator Recommendation May Be Harmful
HealthCentral.com - Jul 24, 2005
Guidant Corp. said Friday that one of its recommendations designed to
correct a problem with its implantable heart defibrillators may actually
increase risk to patients.
Warning issued for Guidant device fix
Indianapolis Star, United States - Jul
23, 2005
... revised one of its defibrillator recall
advisories Friday, saying the recommended fix actually could worsen risks
for some patients. ...
Guidant adds to heart-device alerts; 28,000 patients effected
USA Today - July 19, 2005
....The nine types of pacemakers, which correct irregular heartbeats, may
fail suddenly or cause a high rate for too long, Guidant says. It said a
sealing component can degrade, allowing body fluids into the device.
Update 6: Guidant Warns on 28,000 Pacemakers
Forbes - July 18, 2005
... Guidant Corp., already under fire for
problems with its implantable defibrillators, on Monday warned physicians
replacements might be needed for nine pacemaker models made between 1997 and
2000.
Guidant Says 28,000 Pacemakers May Need Replacement
Guidant Corp. say doctors should consider replacing cardiac pacemakers
implanted in the chests of 28,000 people worldwide ...
Defibrillator industry accelerating the pace of change
Due to continuing pressure and demand by patients, doctors and the FDA,
Guidant and other defibrillator companies are increasingly releasing more
information sooner about the possible defects of the devices ...
Guidant Issues Warning on 28,000 Pacemakers
Guidant Corp. on Monday warned physicians that replacements might be needed
for nine pacemaker models made between 1997 and 2000, of which some 28,000
remain implanted in patients worldwide ...
Defibrillator recall sends patients scrambling
Nervous patients called their doctors Monday to have potentially faulty
implanted heart devices checked out after the company offered to replace
thousands of them because of flaws ...
FDA Gives Highest Warning About Certain Guidant Defibrillators
The government says a malfunction in some of the Guidant Corporation
defibrillators recalled recently could cause serious injury or death ...
Guidant defibrillators recalled
A series of failures in Guidant Corp. defibrillators that resulted in two
deaths prompted the company to issue warnings to doctors ...
FDA halts expansion of network to monitor medical device safety
North Reading medical technology consulting firm, said data from more
hospitals might have led to earlier detection of problems with Guidant's
defibrillators ...
Lawsuit claims faulty implanted defibrillator caused death
The lawsuit, filed Wednesday in Duval Circuit Court, claims Guidant, of
Indianapolis, was aware of problems with its defibrillators for about three
years, but ...
FDA: Some Guidant Defibrillators Recalled
The FDA says Guidant Corp. is recalling certain implantable defibrillators
and cardiac resynchronization defibrillators ...
New worry for heart patients as Guidant defibrillators are ...
The latest Guidant safety announcement affects the Contak Renewal 3 model,
Contak ... At least 74,900 defibrillators worldwide are now under a safety
warning, with ...
