Defect First Identified in 2002

Over a period of 2 years, between November 2000 and November 2002, Guidant made and sold 37,000 of the affected devices, and 24,000 patients worldwide still have the implants. To date, the company has identified 26 cases of device failure due to the defect (an overall failure rate of 0.07%), and no other deaths have been reported.

The company first detected the shorting problem early in 2002, after a few defective devices had been explanted from patients and returned to the company for analysis. Guidant subsequently made manufacturing and device design changes to correct the defect and began shipping the revised models in November 2002. Although the corrective modifications were reported to the FDA, no notification was made directly to physicians at that time, Richard Fogoros, MD, Medical Advisor in Guidant's R&D department, told Medscape CRM.

The shorting defect is related to the design of the header where the leads are plugged in, a design that was unique to these particular device models, Fogoros explained. Under certain circumstances (and, he pointed out, there are actually 4 things that need to go wrong for this to happen), the wires can short out when the ICD is preparing to deliver a shock. As a result, the device becomes nonfunctional and the shock is ineffective.

This event is extremely rare, Fogoros said, occurring at a rate of only 0.002% per month, regardless of the age of the device. And comparatively, it is a much smaller risk than the industry average rate of ICD device failure due to random component failure, which is 0.01% per month. According to Fogoros, there is no chance that this problem could show up in any other models of Guidant ICDs on the market, as the flawed header design was unique to that particular model of ICD and has not been used since.

What is at issue for many doctors is Guidant's decision not to inform them of the device flaw until 3 years after it was initially identified. Fogoros told Medscape CRM that the company had no plans to directly communicate with doctors about the problem until recent publicity surrounding the college student's death brought it to the forefront (in addition to the New York Times article, the young man's case reportedly has been submitted for publication in an upcoming issue of the medical journal Heart Rhythm).

But Fogoros vigorously defended the company's course of action. "The risk of failure [with this device] is an order of magnitude less than one would expect from random component failure." Thus, replacing the device would not yield any benefits statistically. In fact, he said, "the FDA was made aware of each event as it occurred from the beginning... those reports are published in a public database on the Web by the FDA that anybody can access. This data's been out there in public the whole time."

According to Fogoros, the notification letter was issued to inform physicians of the data and does not encourage them to take any special action beyond the continued routine monitoring of their patients. "We are not advising them to replace these devices. Obviously, they need to consider what they see as their risk and their patients' individually, but based on the information that we have, we feel that this is pretty solid information; these devices are as safe as any [ICD] that's out there today," he said.

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