FDA Backs Follow-Up Exams for Implantable Defibrillators
Patients with certain pacemakers and defibrillators urged to undergo follow-up exams
THURSDAY, July 13 (HealthDay News) -- The U.S. Food and Drug Administration announced that it fully supports Boston Scientific/Guidant's recommendation that physicians perform immediate follow-up exams on all patients who received pacemakers and defibrillators that are at risk for malfunction. The FDA will closely monitor the situation.
In late June, Boston Scientific Corporation recalled a subset of cardiac devices including Insignia and Nexus pacemakers, Contak Renewal TR/TR2 cardiac resynchronization pacemakers and Ventak Prizm 2, Vitality and Vitality 2 implantable cardioverter defibrillators, due to suboptimal performance of a supplier's low-voltage capacitor. Devices could malfunction, resulting in premature battery depletion or even loss of therapy.
Of the 27,200 devices in this group, there have been five confirmed events so far, of which four were detected after implantation. Two patients experienced syncope due to loss of pacing output. There have been no reported deaths thus far.
As a result, the company urged physicians to schedule appointments with patients implanted with affected devices as soon as possible. The company's engineers will be testing the retrieved devices and analyzing the results during the next two months. They plan to communicate the findings to the FDA and physicians as soon as they become available.