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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: We found that more than 500 000 pacemakers and ICDs were affected by recalls and safety alerts in the United States between 1990 and 2000, and that the annual rate of recall is increasing. Dr Stanton's criticism that our article reporting these data generated "unfounded" concern among patients and physicians is misdirected. The device advisory rates, malfunction rates, and explantation rates of the manufacturers should be readily available to patients and health care professionals; to this point they have not been. We commend Stanton for reporting Medtronic's rates in his letter. To our knowledge, this is the first time a device company has reported their rates in a medical journal despite more than 30 years of device manufacturing and tens of millions of implants worldwide.

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