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RECENT CASES |
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GENERAL INFORMATION |
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Guidant Pacemaker Warning |
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| On July 18, 2005, Guidant
Corporation 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. Pacemakers send
electrical pulses to the heart to accelerate
a slow heart beat, and have a seven- to 10-year
life span before they must be replaced. |
| Several patients implanted
with its pacemakers have lost consciousness
or developed possible heart failure, Guidant
said, and one patient may have died due to
a faulty pacemaker. |
| On September 22, 2005,
Guidant issued a recall for some of its Insignia
and Nexus implantable pacemakers because of
failures, including nine cases requiring emergency
hospitalization. Guidant said that as of September
6, 36 out of 49,500 devices experienced loss
of pacing output, while 16 out of 341,000 devices
suffered a telemetry failures. |
| The recall expanded in
June 2006 when Boston Scientific, which bought
Guidant in 2006, announced in the recall of
more defibrillators and pacemakers. The recalled
devices include Insignia and Nexus brand pacemakers,
Contak Renewal TR/TR2 cardiac resynchronization
pacemakers. On June 23, 2006 Guidant issued
a warning letter to physicians, informing them
of the recall expansion and urging patient
exams and possible removal of the defective
devices. |
| Guidant’s warning
states that a sealing component in the pacemakers
has degraded in some cases, resulting in higher-than-normal
moisture in the devices and possible malfunction. |
| Guidant said it has identified
69 failures among the pacemakers -- all after
they had been used for at least three years.
The models include the following pacemakers:
Pulsar Max, Pulsar, Discovery, Meridian, Pulsar
Max II, Discovery II, Virtus Plus II, Intelis
II, Insignia, Nexus, Contak TR, and Contak
Renewal TR/TR2. |
| Guidant has confirmed
twenty reports of loss of pacing output associated
with this failure, including five patients
experiencing syncope. Loss of pacing output
has also been associated with reports of presyncope
requiring hospitalization. Guidant has received
two reports of sustained Maximum Sensor Rate
("MSR") pacing in which heart failure
may have developed in association with sustained
high rate pacing. |
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Our Guidant
defect lawyers have years of experience
successfully representing patients
with faulty or defective medical implants. |
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There is no
charge or obligation for our review
of your case. |
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We are pleased
to visit Guidant patients, or families
of loved ones who died, at or near
where you live and at no cost, to discuss
your legal rights and answer your questions. |
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To assist
our clients with their claims, we have
on staff nurses with cardiac training
and have retained physicians to provide
expert advice. |
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| According to Guidant,
physicians should consider replacing the devices
for patients who are dependent on the devices.
Patients should seek medical attention immediately
if they notice shortness of breath, dizziness,
lightheadedness or a prolonged fast heart rate. |
| To read copies of "Urgent
Medical Device Safety Information" letters
sent to physicians and Guidant patients regarding
Guidant defibrillators and pacemakers, click
here. |
| In July 2005, Guidant recalled almost 109,000 heart defibrillators. Defibrillators, three times the size of pacemakers, are also implanted; they shock the heart back into rhythm when it beats too quickly. To learn more about this recall, click here. |
| The law in most states provides
individuals with legal claims and the right to
compensation for injuries they suffer as a result
of a defective product or the negligence of another.
The injured person may file a lawsuit seeking compensation
for his or her pain and suffering, medical expenses,
lost past and future wages and punitive damages. |
| Damages sought against manufacturers
of an allegedly defective medical device typically
include: |
- Physical pain and suffering, mental anguish
and physical impairment;
- Medical expenses associated with the allegedly
defective product; and
- Loss of earnings and/or earning capacity.
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| For persons who have died,
family members can bring a wrongful death action. |
| Founded in 1972, Lieff Cabraser Heimann & Bernstein,
LLP is an over fifty attorney
law firm with offices in San Francisco, New York and Nashville. For the last seven years,
the National Law Journal has recognized Lieff Cabraser
as one of the top 20 plaintiff law firms in America. |
| For our personal injury cases, we bring a team of experienced
lawyers. Each client is assigned an individual lawyer. In addition, we have
on staff multiple nurses, legal assistants, scientific analysts and case
clerks to assist the attorneys. To learn more about our firm, click
here. |
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| Copyright © 2010 Lieff Cabraser Heimann & Bernstein, LLP |
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