Stephen J.LurieMD, PhDIndividualAuthor
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.
Eagle KA. Safety of Implantable Cardiac Devices—Reply. JAMA. 2002;287(7):839–840. doi:10.1001/jama.287.7.839
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