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Guidant Notifies Doctors About Flaw in Defibrillators

Source: Business Wire
Published: May 25, 2005

A defibrillator implanted in 24,000 people worldwide contains a design flaw that has caused some units to malfunction and short-circuit, Guidant Corp., a medical device maker, said in its May 23, 2005, letter to physicians. There have been 26 reports of failure including one death regarding these devices, the company said.

The problem is in Guidant�s VENTAK PRIZM 2 DR implantable defibrillators manufactured prior to November 2002. Devices manufactured after this date are not affected, the company said.

On May 24, 2005, the New York Times reported that Guidant sent the letter to doctors only after learning that it was preparing an article about the device. In addition, the New York Times said Guidant acknowledged that it had waited 3 years to tell patients and their doctors about the electrical problem found in the devices--because the �failure rate was very low and replacing the devices might pose greater patient risks.�

Patients with a VENTAK PRIZM 2 DR should consult with their physician if they have questions regarding their device, particularly if they have recently received a defibrillation shock. Guidant recommends that physicians continue monitoring patients every three months as described in the labeling. Guidant does not recommend early replacement of these devices. The company believes the overall device reliability remains high.

In December, Johnson & Johnson announced it plans to buy Guidant for 25.4 billion. On Tuesday, Johnson & Johnson, in a statement, reaffirmed its confidence in its decision to acquire Guidant and said it anticipates a closing of the transaction in the third quarter of 2005.

Read Full Story at Business Wire

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