LYCOS RETRIEVER 
Guidant: Guidant Defibrillator
built 267 days ago
Guidant is communicating to physicians about a failure in its CONTAK RENEWAL (Model H135) and CONTAK RENEWAL 2 (Model H155) cardiac resynchronization therapy defibrillators manufactured on or before August 26, 2004. The failure involves deterioration in a wire insulator within the lead connector block that, in conjunction with other factors, results in a short to the active titanium case and results in the device’s inability to deliver therapy. Fifteen reports of this failure mode have been confirmed in devices built on or before August 26, 2004 from approximately 16,000 devices implanted worldwide. This includes a patient death on May 30, 2005 involving a device returned earlier this week. The device is still being tested but it appears to have experienced this failure in conjunction with attempted delivery of at least one high-voltage therapy. Approximately 11,900 devices built on or before August 26, 2004 remain in service, including approximately 6,700 in the United States.
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Guidant is a large manufacturer and distributor of implantable cardioverter defibrillators (ICD), cardiac pacemakers and devices for cardiac resynchronization therapy (CRT). These ICD, pacemaker and CRT devices are used to treat abnormalities in heart rate and heart rhythm in patients who have heart disease or heart failure. The devices are implanted in the chest area and monitor heart function. If an irregularity is detected, then an electrical impulse (shock) or a series of impulses is/are delivered to the heart to restart normal function. Normally, defibrillators and pacemakers are implanted in older patients who have developed heart disease during the later stages of life. Due to improvements in pacemaker technology, these devices are now being widely implanted and used in younger patients who have congenital (at birth) heart problems.
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Some newer Guidant defibrillator models have a switch that can stick in the “off” position, making them unable to treat abnormally fast heart rhythms. Over 46,000 patients have already been implanted with these devices. Because the flawed Guidant devices can cause health problems in some patients, they are part of a Class 2 recall. Doctors have been told not to continue implanting these Guidant models:
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Guidant defibrillators have caused numerous problems. Guidant, a medical device company, is under fire for not telling patients that problems exist with implanted heart defibrillators. Which are devices that aid in regulation of heart rate and heart functions related to heart disease. They are commonly known as Implantable Cardioverter Defibrillators or ICD. It’s possible that as many as 50,000 of the
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Guidant medical reports show 45 defibrillator malfunctions, resulting in at least two deaths since May 30, 2005. More than 38,000 patients throughout the United States rely on the Guidant debibrillators. The first signs of the Guidant malfunction began in 2002, when officials detected a potential problem with the wiring of the VENTAK PRIZM 2 DR (model 1861), and short circuiting. Guidant stated that this flaw would be corrected in future models, so they only began to notify doctors of this potential malfunction in May 2005. Two months later, the FDA issued a voluntary recall.
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Guidant Corp. has recalled several models of its cardiac defibrillators due to defects in the devices and numerous reports of device failure and death. The defibrillator recall and its follow-up advisory combined affect approximately 74,900 devices worldwide. The implantable cardioverter defibrillators, or ICDs, are intended to sense irregular heart rhythms and to send an electrical pulse to the heart to shock it into beating properly. The Guidant defibrillator defects include short circuiting, problems with the magnetic switch and computer memory problems. The defect that causes short circuiting of the device has caused two deaths to date, including the sudden death in March 2005 of a 21-year-old college student. Following are details of the models affected by the recall and the follow-up advisory:
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