Medical Device Daily

In a clear attempt at public relations back-and-fill, Boston Scientific (Natick, Massachusetts) has garnered statements from both the FDA and the Heart Rhythm Society (Washington) supporting the handling of its most recent recall of several models of pacemakers and implantable defibrillators.

Boston Scientific late last month issued a statement concerning problems with the safety of devices implanted in more than 27,000 patients and recalled 23,000 unused devices made by its Cardiac Rhythm Management business, formerly Guidant (Medical Device Daily, June 27, 2006), which was acquired by Boston Sci this past spring.

The recalls served to bring to nearly 140,000 the number of devices made by Guidant that have been recalled over the past year.

The FDA yesterday placed on its web site a statement saying that it “fully supports“ the company's recommendation that physicians perform follow-up exams of patients with devices that may be susceptible to this malfunction.

The agency said that it is “closely monitoring the situation“ and that it met with Boston Scientific last week to discuss plans for investigating the problem, inform physicians and resolve the problem as quickly as possible.

While the statement supports Boston Scientific's actions, it also seemed to serve the purposes of the FDA, which has come under recent fire for lacking the grit to pursue necessary enforcement actions and a decline in those actions (MDD, June 29, 2006).

Thus, Daniel Schultz, MD, director of the agency's Center for Devices and Radiological Health, said, “While information about the problem with these devices is still very preliminary, FDA is committed to keeping the public informed. We support Guidant's decision to notify physicians and hospitals early in the investigation, and we believe that retrieval of non-implanted devices is a prudent first step.“

He added: “Analysis of returned devices may uncover clues that will allow Guidant to make further recommendations to physicians regarding patient care. Early public notification was one of the important recommendations that emerged from last fall's meeting of the Heart Rhythm Society.“

Anne Curtis, MD, immediate past president of the Heart Rhythm Society, said that the society “applauds this proactive, collaborative effort to inform patients and physicians about the most recent device notifications. This is a monumental step in providing optimal patient care …“

Curtis also put in a plug for the society, saying that Boston Scientific's action was based “on the Society's draft recommendations released in April [MDD, April 27, 2006]. We believe the most important step is for patients to contact their heart rhythm specialist to determine the best course of action.“

In issuing its safety alert last month, Boston Scientific said that the problems with the devices included “intermittent or permanent loss of therapy, premature battery depletion or other malfunctions.“

At the time, the company confirmed five reports of device malfunction among some 27,200 patients implanted with the devices, worldwide. One malfunction, it said, occurred at the time of implantation. In four cases, the patients needed to have the device replaced. The patients lost consciousness in two of these cases.

There have been no reported deaths.

The company said it has identified certain lots of a supplier's low-voltage capacitor as the likely source of the problem, and in a follow-up conference call company executives suggested that there may be other such problems, yet to be revealed, about these devices.

The affected products include certain models of the Insignia and Nexus pacemakers, Contak Renewal TR/TR2 cardiac resynchronization pacemakers, and Ventak Prizm 2, Vitality and Vitality 2 implantable cardioverter defibrillators. These devices were manufactured by Guidant and implanted in patients between December 2005 and June 2006.

Boston Scientific said it is “actively investigating“ the capacitor failure to determine the cause, the rate of occurrence and the time to failure.

“Over the next 60 days, the company's engineers will be testing the retrieved devices and analyzing the results. The company will communicate its findings to the FDA and physicians as soon as they are available,“ it said.

As a “cautionary step,“ Boston Scientific said it has notified physicians to schedule appointments with patients implanted with affected devices to examine the patient to identify any problems and to obtain information concerning when and under what circumstances these devices may fail.

“We encourage patients who have been contacted by their physicians because they may have one of the affected devices to follow their recommendation and make an appointment to have the device checked as soon as possible,“ the CDRH's Schultz said.