Medtronic “Dear Doctor” Letter Impacts 37,000 Kappa/Sigma Pacemakers
This article was originally published in The Gray Sheet
Executive Summary
Medtronic is advising physicians to consider replacing certain Kappa and Sigma pacemakers after the devices were shown to fail at a higher-than-expected rate
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Firm's May 18 "Dear Doctor" letter advising of potential wire separations in certain Kappa and Sigma pacemakers is deemed a Class I recall by FDA, the most serious category, the agency announces June 11. Medtronic had warned that wire separations in certain models could cause a loss of rate response, premature battery depletion, loss of telemetry or no output. Therefore, the firm advised that physicians consider device replacement for patients who are pacemaker-dependent. Medtronic has made no new recommendations as a result of the recall classification (1"The Gray Sheet" May 25, 2009, p. 15)
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