Guidant Pacemaker Warning

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 Warning Explained

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.

Lieff Cabraser represents persons across America injured by defective Guidant and Ancure heart devices. Our firm was one of the first law firms in the U.S. to file a Guidant defibrillator recall lawsuit.

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.

Earlier Guidant Recall of Heart Defibrillators

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.

Legal Rights of the Injured

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.

For persons who have died, family members can bring a wrongful death action.

	Our Guidant defect lawyers have years of experience successfully representing patients with faulty or defective medical implants.
	There is no charge or obligation for our review of your case.
	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.
	To assist our clients with their claims, we have on staff nurses with cardiac training and have retained physicians to provide expert advice.

About Lieff Cabraser

Founded in 1972, Lieff Cabraser Heimann & Bernstein, LLP is a 50-plus attorney law firm with offices in San Francisco, New York and Nashville. For each of the last four years, the National Law Journal has recognized Lieff Cabraser as one of the top plaintiffs’ 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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