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Guidant Pacemaker | Defibrillator Recall News Article
 
August 1, 2005
The New York Times, "New Report of Problems at Guidant"
          About two weeks before a college student with a flawed heart device died in March, another heart patient implanted with the same model that also failed almost died, according to a government filing by the device's maker, the Guidant Corporation.
          The filing, which was first publicly disclosed earlier this month when the Food and Drug Administration posted it in a database, shows that a heart patient implanted with a specific type of Guidant unit "presented to a hospital" around the beginning of March after suffering cardiac arrest, an often fatal condition that the device known as a defibrillator is intended to prevent. (Doctors often use the term "presented" to describe a patient's condition upon arrival at an emergency room.)
          It was determined by Guidant that the patient's device, known as a Ventak Prizm DR 2, had failed because it had short-circuited at some point, the filing shows, though it is not clear when Guidant made that determination. The patient was revived, possibly by the type of rescue defibrillator used by paramedics. Two weeks later, a 21-year-old college student, Joshua Oukrop, died of cardiac arrest. Guidant has previously said that his Prizm DR 2 had also short-circuited, though it said it was not known when it failed.
          After Mr. Oukrop's death, it was disclosed by The New York Times in late May that Guidant officials had known for three years that the same model had repeatedly short-circuited but had decided not to alert doctors. Ever since, Guidant, which is based in Indianapolis, has found itself under intense scrutiny and has recalled tens of thousand of defibrillators and pacemakers, including some versions of the Prizm DR 2.
          Yesterday, a spokesman for Guidant declined to respond to questions in an e-mail message seeking added information about the details of the incident.

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