Pacemaker/Defibrillator FAQ

Should I get a pacemaker or a defibrillator?
When the heart’s natural pacemaker malfunctions, it may send out erratic signals—too slow, too fast or too irregular to stimulate sufficient contractions of the chambers of the heart. An erratic heartbeat, also known as an arrhythmia, can cause it to pump less effectively.

Arrhythmias can cause problems with contractions of the heart chambers by not allowing the chambers to fill with an adequate amount of blood because the electrical signal is causing the heart to pump too fast. Arrhythmias also do not allow enough blood to be pumped out to the body because the electrical signal is causing the heart to pump too slow or too irregularly.

What are the components of a pacemaker or defibrillator?
To put it simply, pacemakers and defibrillators are made up of three parts:
• A pulse generator, which has a sealed lithium battery and an
electronic circuitry package. The pulse generator produces
the electrical signals that make the heart beat. Many pulse
generators can also receive and respond to signals that are
sent by the heart itself.
• One or two wires (also called leads). Leads are insulated,
flexible wires that conduct electrical signals from the pulse
generator to the heart. The leads may also relay signals from
the heart back to the pulse generator.
• Electrodes on each lead.

The procedure for implanting either pacemakers or defibrillators is very similar. It takes about two to three hours, from start to finish.

Did the manufacturers mishandle critical information?

There is some controversy regarding Medtronic’s, Guidant’s and St. Jude Medical’s handling of information about some of their implantable pacemaker or defibrillator models.

Various pacemaker or defibrillator lawsuit allegations against Medtronic, Guidant and St. Jude Medical indicate that in filings made with the Food and Drug Administration, rather than disclosing defects, the companies attempted what might be called a silent recall—merely saying that they were making “enhancements” or “improvements” to a perfectly good device. Instead of coming out and revealing the problems with their implantable pacemakers and defibrillators, Medtronic, Guidant and St. Jude Medical sought to keep the damaging information as a “trade secret.”

Can I file a product liability lawsuit for having a faulty Medtronic, Guidant or St. Jude Medical pacemaker or defibrillator?
Yes. More than 300 Guidant class action lawsuits and individual suits had been filed as of June 2006. In some cases, the problem was insulation damage that would cause the devices to fail within five years of implantation. Others may have faulty low-voltage capacitors. Guidant has recalled or issued safety warnings for 200,000 pacemakers and 88,000 defibrillators.

Medtronic has recalled 13,000 defibrillators as of May 2005. An internal short may occur in Medtronic’s devices, causing battery depletion within days or even hours.

St. Jude Medical revealed in September 2005 that 26,000 of its heart devices may be affected by cosmic radiation. Others have a software problem that can potentially cause them to malfunction.

What financial compensation can I recover in a Medtronic, Guidant or St. Jude Medical pacemaker or defibrillator claim?
You can recover for these factors:
• The cost of past and future medical care, including removal and
replacement of the defective device
• The cost of necessary rehabilitation
• Loss of past and future wages
• Loss of earning capacity and related fringe benefits
• Emotional trauma
• Mental disability
• Pain and suffering associated with the failure of the device

Can everyone who has a Medtronic, Guidant or St. Jude Medical pacemaker or defibrillator bring a lawsuit?
Not necessarily. In order to recover damages in a Medtronic, Guidant or St. Jude Medical defective pacemaker or defibrillator lawsuit, it is not enough to establish that you have a Medtronic, Guidant or St. Jude Medical device. It must also be shown that the product is defective and either has malfunctioned or is likely to do so.

Are there time limits for seeking compensation for defective products?
As with all civil lawsuits, pacemaker and defribrillator recall litigation is subject to statutes of limitations—that is, a specific time period in which legal action must be taken. If your claim has not been resolved by settlement, it is important that your lawsuit be filed before expiration of the statute of limitations.

No matter how valid or how strong your claim might be, when the statute of limitations expires your claim will expire with it, and you will be forever barred from obtaining financial compensation. Statutes of limitations vary in length from state to state, so it is important that you contact a Medtronic, Guidant or St. Jude Medical pacemaker and defribrillator recall attorney.

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