| |
replaced. An estimated 28,000 of the pacemakers
remain implanted in patients worldwide, with about 18,000 of those in U.S.
patients. This warning was issued just one month after the company recalled
almost 109,000 of its defibrillators.
According to Guidant Corp., a sealing component in the pacemakers had degraded
in some cases, resulting in higher-than-normal moisture in the devices that
could cause a malfunction. Because of this, several patients had lost
consciousness or developed possible heart failure. The company reported the
death of one person whose pacemaker might have failed.
The pacemakers affected by the notification
were:
- PRIZM 2 DR, Model 1861, manufactured on or
before April 16, 2002
- CONTAK RENEWAL, Model H135, manufactured
on or before August 26, 2004
- CONTAK RENEWAL 2, Model H155, manufactured
on or before August 26, 2004
Guidant told physicians to consider replacing
the affected pacemakers in patients who depend on them for survival, or roughly
20 to 40 percent of pacemaker patients. The company said it would pay for the
replacements at no charge through the end of 2005, whether or not the warranty
has expired. Guidant stated it would also reimburse patients up to $2,500 for
medical expenses.
The company said it had identified 69 failures
among the pacemakers after each had been used for at least 44 months. The models
are: Pulsar Max, Pulsar, Discovery, Meridian, Pulsar Max II, Discovery II,
Virtus Plus II, Intelis II and Contak TR.
Guidant also informed the Food and Drug
Administration that it is recalling another set of defibrillator devices called
PRIZM AVT, VITALITY AVT, RENEWAL 3 AVT and RENEWAL 4 AVT. The company has said
the devices are subject to a memory error, which may affect device performance.
The Guidant defibrillators are implanted into
the chest cavity of patients and are intended to monitor irregularities in heart
rhythm (arrhythmia). When functioning properly the units can detect when the
heart is beating out of rhythm, and deliver a series of electrical shocks to
correct the arrhythmia.
Guidant Corp. has said that the devices have
malfunctioned at least 45 times, causing two deaths. The malfunction that is the
subject of the recall causes damage to the device’s circuitry, potentially
resulting in the inability to deliver the required shock during episodes of
arrhythmia. This malfunction could lead to a serious, life-threatening event.
Importantly, the device does not give any sign of impending failure, and there
is no test that predicts whether any particular device will fail. Guidant
recently conceded that it waited three years before telling doctors and patients
about the electrical defect.
If you have one of the recalled Guidant
defibrillators or pacemakers, contact your doctor immediately to discuss your
medical options. The FDA is not making a recommendation on whether individual
patients who have one of the Guidant devices should have it removed and
replaced. This is a decision that should be made by a patient in consultation
with his or her physician, based on the specific medical situation of the
patient. Removal and replacement of the device may pose some risk, so it is
important that patients and physicians carefully discuss this matter before
making a decision.
Hardison & Associates is representing patients and
families who have been harmed by a malfunction of Guidant defibrillators and
pacemakers. If you feel you have been harmed due to use of Guidant medical
devices, contact our firm today at 1-800-434-8399 or through our
online
form.
CLICK
HERE FOR A FREE CASE REVIEW |
