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February 20, 2002

Safety of Implantable Cardiac Devices—Reply

Author Affiliations

Stephen J.LurieMD, PhDIndividualAuthor

JAMA. 2002;287(7):839-840. doi:10.1001/jama.287.7.839

In Reply: While Dr Stanton states that a very small percentage of Medtronic devices implanted between 1990-2000 required explantation, the psychological and financial implications of advisories involving more than 125 000 patients are not insignificant. Furthermore, I pointed out in my Editorial that the number of advisories surrounding pacemakers—a far more mature technology than internal cardioverter-defibrillators—exhibited a surprising peak in the late 1990s. This suggests that while the clinical capabilities of device therapy steadily improved, perhaps the systems for quality assessment and monitoring remained entrenched in the past. It would be reassuring if the steadily advancing functionality of device therapy were accompanied by a system that reduced safety recalls.