Boston Scientific/Guidant 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.

In the meantime, as a cautionary step, Boston Scientific/Guidant has notified physicians to schedule appointments with patients implanted with affected devices as soon as possible. Physicians should 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," Dr. Schultz said.

"The Heart Rhythm 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 and is based on the Society's draft recommendations released in April," said Anne B. Curtis, M.D., FHRS, Immediate Past President, Heart Rhythm Society. "We believe the most important step is for patients to contact their heart rhythm specialist to determine the best course of action."

FDA is interested in receiving information about problems with any devices and encourages hospitals and the public to submit reports directly to MedWatch, the FDA's voluntary reporting program. Reports may also be submitted by phone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857-9787; or online at http://www.fda.gov/medwatch/report.htm.

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