FDA is investigating energy levels in external biphasic defibrillators with shocks less than or equal to 200 J. The agency has received reports of 14 events since 2006 in which a 200 J biphasic defibrillator was ineffective in providing defibrillation/cardioversion therapy to a patient, whereas a subsequent shock from a different 360 J biphasic defibrillator resulted in immediate defibrillation/cardioversion.

The majority of events occurred during attempts at cardioversion of atrial fibrillation, but there was at least one instance with defibrillation of a ventricular arrhythmia as well. FDA is seeking additional information in order to interpret the significance of these events, and to determine whether FDA activities are advised.

If you experience an event similar to those reported above, please report it to the FDA. Note that so far, no change in clinical practice has been announced.

Get all the details:
http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm189259.htm

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