Stephen J.LurieMD, PhDIndividualAuthor
Copyright 2002 American Medical Association. All Rights Reserved.
Applicable FARS/DFARS Restrictions Apply to Government Use.2002
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.
Maisel WH, Stevenson WG, Epstein LM. Safety of Implantable Cardiac Devices—Reply. JAMA. 2002;287(7):839-840. doi:10.1001/jama.287.7.839