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  Guidant Says Defibrillator Recommendation May Be Harmful
Guidant Corp. said that one of its recommendations designed to correct a problem with its implantable heart defibrillators may actually increase risk to patients.

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  Guidant Recall Considered Top FDA Priority
The FDA has classified the defibrillator recall as Class I, its highest priority

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FDA: Some Guidant Defibrillators Recalled: Patients With Affected Models Should Consult Their Doctors, Says FDA

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How Defibrillators Work...

An implantable cardioverter defibrillator (ICD) is a device that monitors heart rhythms, and delivers shocks if dangerous rhythms are detected.

Many ICDs record the heart’s electrical patterns whenever an abnormal heart beat occurs. Doctors can review this record during regular check-ups to help plan future treatment options.

Implantable cardiac defibrillators (ICDs) are small devices, about the size of a pager, that are placed below the collarbone.

Like a pacemaker, an ICD consists of a battery and electrical circuitry (pulse generator) connected to one or more insulated wires. The pulse generator and batteries are sealed together and implanted under the skin, usually near the shoulder. The wires are threaded through blood vessels from the ICD to the heart muscle.

The ICD continuously checks the heart rate. When it detects a too-rapid or irregular heartbeat, it delivers a shock that resets the heart to a more normal rate and electrical pattern (cardioversion). Sometimes the ICD can be programmed to “pace” the heart to restore its natural rhythm and avoid the need for a shock from the ICD. Pacing signals from the ICD are not felt by the patient; shock signals are, and have been described as a kick in the chest.

Stopping the potentially fatal fibrillation is called defibrillation.

Implantable cardioverter defibrillators have been very useful in preventing sudden death in patients with known, sustained ventricular tachycardia or fibrillation. However, recalls linked to ICD's are not uncommon, and with heart disease still the number one cause of death in the United States, the safety of these medical devices is of great concern.

In some cases, these surgically implanted defibrillators can develop an internal short circuit without warning, resulting in failure to deliver a shock when needed. So, at the very moment when the patient's life depends on the reliability of the ICD, the device can malfunction.

Defibrillators that have a documented history of recalls and warnings from the FDA include:

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

VENTAK PRIZM AVT, VITALITY AVT, RENEWAL AVT Devices, CONTAK RENEWAL 3 and 4, RENEWAL 3 and 4 AVT, and RENEWAL RF- Class II - FDA has classified the previous actions taken by Guidant for these devices as a Class II recall. For a Class II recall, the malfunctioning product may cause temporary or medically reversible adverse health consequences, however the probability of serious adverse health consequences is remote.

FDA advises patients to take the following steps:

  • If you have not already been notified, contact your doctor to determine if you have an affected PRIZM 2, CONTAK RENEWAL, or CONTAK RENEWAL 2 device.
  • Continue to keep your regular doctor appointments.
  • If you feel an electrical shock from your device, immediately contact your doctor.
  • If there is an audible "beeping" from your CONTAK RENEWAL or RENEWAL 2 device, immediately contact your doctor or go to the nearest emergency room. Beeping may mean that your defibrillator is damaged.

If you have any questions about your legal rights, please contact us to speak with one of our lawyers. Recognized among the most distinguished law firms in the United States in the Martindale-Hubbell® Bar Register of Pre-eminent Lawyers,™ Janet, Jenner & Suggs, LLC has won record breaking verdicts and settlements through its aggressive advocacy.

Our in-house legal team consists of a physician, five registered nurses, 10 attorneys, and more than 30 staff-members. As one of the nation's premier pharmaceutical liability law firms, we represent consumers nationwide who have been victimized by defective pharmaceutical drugs and medical devices, including Guidant defibrillators.  We have the experience to protect your legal rights and to help you obtain the compensation you deserve.  If you or a loved one has suffered serious side effects from a defective defibrillator, please contact us for an immediate case evaluation.

Many law firms that advertise aggressively on the Internet are actually client brokers who refer virtually all clients to lawyers in other firms and other cities who do the actual work of representing the client. Janet, Jenner & Suggs, LLC, is a traditional law firm that actively represents all of our clients. Robert K. Jenner and Kenneth Suggs, leaders of the pharmaceutical department within the firm, will always be accessible to you. Mr. Jenner and Mr. Suggs, nationally recognized advocates on behalf of victims of defective pharmaceutical products, and their highly experienced team, will always be ready to answer your questions.


We encourage you to contact our lawyers today for an immediate free claim evaluation. You may be eligible to participate in a class action lawsuit on behalf of patients who have been injured, or who have died, due to the serious malfunction of Guidant ICDs. Call 1-888-4-MEDLAW or complete our online claim evaluation form.
 


 

 
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