July 11, 2006 -- As part of the agency's continued commitment to keep the public informed of product safety issues, the Food and Drug Administration (FDA) today is providing this update on pacemakers and implantable defibrillators made by Guidant, a Boston Scientific company.

FDA Supports Boston Scientific/Guidant's Recommendation for Physicians to Conduct Follow-up Exams of Patients

FDA met last week with Boston Scientific/Guidant to discuss the firm's recent announcement that several models of pacemakers and implantable defibrillators should be removed from hospital inventories because they have the potential to malfunction due to failure of the capacitor, which controls how the device holds its power supply. FDA fully supports the company's recommendation that physicians perform follow-up exams of patients with devices that may be susceptible to this malfunction. Problems may include intermittent or permanent loss of therapy, premature battery depletion or other malfunctions. FDA is closely monitoring the situation and met with Boston Scientific/Guidant to discuss their plans to investigation the problem, inform physicians and resolve the problem as quickly as possible.


"While information about the problem with these devices is still very preliminary, FDA is committed to keeping the public informed," said Daniel Schultz, M.D., Director, Center for Devices and Radiological Health, FDA. "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. 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."

Boston Scientific/Guidant has confirmed five reports of device malfunction among some 27,200 patients worldwide in whom these devices were implanted. One malfunction 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 are no reported deaths.

Boston Scientific/Guidant has identified certain lots of a supplier's low-voltage capacitor as the likely source of the problem. 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 the company's Cardiac Rhythm Management Group, formerly Boston Scientific/Guidant's CRM business, and implanted in patients between December 2005 and June 2006. For more information, a letter to both patients and physicians regarding this notification is available at www.guidant.com/physician_communications/ .

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