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Safety of Implantable Cardiac Devices
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To the Editor: Dr Maisel and colleagues1 called into question the safety of pacemakers and implantable cardiac defibrillators (ICDs) and caused undue alarm among device recipients and physicians. They reported that during the past 11 years, 52 advisories affected more than 500 000 patients. This led to stories in the lay press that each of these devices poses significant risk to patients, which may have caused unfounded concern among patients and physicians.
Medtronic's primary concern during the design, manufacturing, and evaluation of these devices is patient safety and well-being. When a potential problem is detected, we perform a Health Hazard Analysis, which predicts the risk to patients and the number of affected devices. Because it is impossible to predict which specific devices will develop the potential problem, advisories include all people with devices that potentially are affected. Today's sophisticated devices offer a number of corrective solutions, such as simple reprogramming, downloadable . . . [Full Text of this Article]
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