Heart Disease :: Improve the safety of implantable cardiac devices

In its ongoing commitment to improve the safety monitoring of implantable cardiac devices and provide earlier notice to doctors and patients of potential problems, the U.S. Food and Drug Administration (FDA) released its retrospective review of malfunctions of implantable cardioverter defibrillators (ICD) and pacemakers occurring from 1990-2002. The findings were presented at the Heart Rhythm Society “Policy Conference on Pacemaker and ICD Performance,” in Washington, DC.

The study is part of the FDA device center’s continuing efforts to improve the medical information it makes available from routine surveillance reports that the agency receives as part of its post market safety monitoring.

The reasons for the increase in ICD malfunction rates have not been established, but potentially could relate to the increased complexity of these devices, manufacturing challenges posed by device complexity, or increased reporting by physicians.

The study also concluded that careful monitoring of device performance is needed, along with better ways for doctors to return explanted devices to companies for analysis and to report adverse events.

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