Louisiana Guidant Defibrillator Information

Guidant defibrillators are used as a method of treatment for Ventricular Tachycardia (VT) and Ventricular fibrillation (VF), two heart conditions involving the rhythm of the heart (arrhythmia). Both conditions have the potential to be fatal. Using medicines and surgery, Tachyarrhythmias can sometimes be treated without the use of an implant. The purpose of non-implant methods of treatment is to eliminate the heart tissue causing the arrhythmia. When this method of treatment fails, an implanted electronic device such as a Guidant defibrillator may be used to treat the condition. An implant device delivers electrical current to the heart in order to slow it to a more normal rhythm. In the event of an emergency, an arrhythmia can be treated by on-site medical personnel using a traditional external defibrillator. However, the long-term treatment of a patient suffering from one of these two types of arrhythmias requires a special solution, such as a Guidant defibrillator.

On June 17, 2005, Guidant Corporation recalled nearly 50,000 of its Guidant defibrillators already implanted in patients worldwide due to malfunctions with the device, many of which could lead to serious injury or death. The Guidant defibrillator recall includes several Guidant defibrillator models. According to Guidant, the recalled Guidant defibrillators have reportedly failed at least 45 times and have caused at least two deaths as of May 30, 2005.

On May 23, 2005, Guidant issued a safety advisory concerning its Guidant defibrillators to physicians, reportedly after the company learned the New York Times was preparing an article. The Times later reported Guidant had delayed telling doctors or patients that the Guidant defibrillators contain a flaw for three years. The flaw has caused a small number of Guidant defibrillators to short-circuit and stop working.

Guidant advised physicians to halt use of five models of Guidant defibrillators. Guidant said it is advising doctors about safety problems with its Contak Renewal 3 and 4, Renewal 3 and 4 AVT, and Renewal RF implantable cardioverter Guidant defibrillators, or ICDs. The Renewal 3 and 4 AVT models were also included in the Guidant defibrillator recall. Guidant said in a statement: “As a precautionary measure, physicians should discontinue implants of these devices pending further notice.”

On July 1, 2005 the FDA urged users of Guidant defibrillators to consult with their doctors. On January 21, 2006, additional models were placed on the list of Guidant defibrillator models placed under the Guidant defibrillator recall.

Your physician may recommend a Guidant defibrillator-type device for one or more of the following reasons:

• You have experienced at least one episode of VT or VF.
• You have passed out due to an irregular heartbeat.
• You have noticed an especially fast, reoccurring heartbeat.
• Medicinal or surgery-based treatments for your heart condition in the past have failed to yield acceptable results.
• You have incurred serious side effects from drug therapies.
• You have suffered a heart attack and your ejection fraction is relatively low.

A Guidant defibrillator can use multiple types of energy to restart a failing heart, including:

• Defibrillation – For highly irregular, very fast heart rhythms, the Guidant defibrillators can deliver a high energy shock to restore the heart to a normal rhythm.
• Cardioversion – If the arrhythmia is especially fast, the Guidant defibrillator can deliver a one-time, low energy shock to align the heart to a normal rhythm.
• Anti-tachycardia pacing (ATP) – For fast rhythms within a semi-normal range, the Guidant defibrillator sends a series of rapid, small pacing pulses to interrupt the arrhythmia.

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