Guidant Heart Defibrillators
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Guidant Heart Defibrillator News
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June 2nd, 2005
"Guidant could face legal and regulatory problems for flawed heart aid"
The New York Times and Wall Street Journal reported Guidant Corp. continued to sell potentially flawed implantable heart defibrillators for months after making changes to the device to fix an electrical problem. Reports indicate Guidant could face legal and regulatory problems for selling older devices with a possible flaw while improved ones were available.
The device is called the Ventak Prizm 2 DR Model 1861, and it is implanted under the skin in the chest to shock a chaotically beating heart back into a normal rhythm. According to reports, the company told doctors last week that it had fixed the flaw in devices produced after mid-2002, but the Times said data provided by Guidant to a Minnesota hospital suggests old versions continued to sell.
At Abbott Northwestern Hospital in Minneapolis, nine patients received implants of defibrillators made before April 2002 from May to September 2002. A 21-year old college student died after receiving the device –which the company identified as one of the 26 cases of malfunction.
Guidant urged doctors last week not to replace older units because the risks of replacing them outweighed dangers of the actual device. The company issued a statement to the Times saying it believed reliability data showed that even with improved devices, older versions were still reliable.
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