Guidant Backs Defibrillator
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Medical device maker Guidant Corp. on Thursday stood by its decision to continue selling an implantable heart defibrillator for months after a potential flaw prompted a redesign, saying the original device was still reliable.
“The reliability data showed that the original Ventak Prizm 2 DR, like the enhanced version, was a highly reliable lifesaving product,” said Steve Tragash, Guidant’s director of corporate communications.
“Current data continues to support the reliability of this product.”
Last week, the Indianapolis-based company told doctors that the Prizm 2 DR defibrillator had failed in a small number of cases because of an electrical flaw. It also said that it had fixed the flaw in devices made after mid-2002.
But data provided by Guidant to a Minnesota hospital suggests that from May to September 2002, nine patients at Abbott Northwestern Hospital received implants of defibrillators that were made before April 2002, the New York Times reported Thursday.
Tragash said Guidant identified two instances of an electrical failure in the defibrillator in early 2002.
Neither instance resulted in injury to the recipient, he said.
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