Guidant Defibrillator Attorneys
Guidant Announce Known Design Flaws
It is alleged that despite knowing that the device contained a flaw that
could cause a short-circuit, Guidant did not tell doctors or the 24,000
people implanted with its defibrillator about the problem for three years.
The defibrillator, a Ventak Prizm 2 Model 1861, has reportedly been linked
to at least 26 short-circuiting incidences, including the death of a 21-year-old
cardiac patient. Doctors say that if they had been notified of the flaw
earlier, they would have replaced the patient's device, possibly saving
his life.
Similarly, Medtronic Inc. informed doctors that a battery
used in one of its models was draining much faster than it should have,
affecting about 87,000 devices. No deaths or injuries have been associated
with Medtronic's devices, but Medtronic warned that the battery problem
could get worse over time, causing concern in .2 percent to 1.5 percent
of its units. Since Medtronic's announcement, the company has said doctors
worldwide have replaced 13,000 of one of its models.
The short-circuit in the Guidant defibrillator can occur when the device
builds an electrical charge used to shock a heart that is beating irregularly.
In three reported cases, when doctors induced abnormal heart rhythms in
patients with the device, it did not work, forcing doctors to use external
defibrillators to restore a normal heart beat. According to Guidant, the
electrical malfunction in the Ventak Prizm 2 Model 1861 is unique to units
produced from mid-2000 through mid-2002. Since Guidant fixed the flaw,
no other electrical problems have been reported.
While Guidant informed the FDA of the malfunction in its August 2003
annual report, it has been asserted that the company made no move to alert
doctors or heart patients of the malfunction until after it was told that
the New York Times was preparing an article on May 23, 2005 about the
faulty devices. On their website, Guidant claims their product is reliable
and performs correctly under most circumstances, and does not recommend
the defibrillators be replaced.
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