Important Safety Information on Medtronic Sigma Series pacemakers… — recall 24146
Health Canada — Marketed Health Products · Canada · 2005-11-30
As described by Health Canada — Marketed Health Products: Important Safety Information on Medtronic Sigma Series pacemakers- Medtronic of Canada Ltd. - For Health Professionals
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Reported risk: In accordance with Medtronic's commitment to keeping you informed about the performance of our products, we write to advise you about an issue with a specific subset of Sigma ® series pacemakers that may fail due to separation of interconnect wires from the hybrid circuit. This failure mechanism may present clinically as loss of rate response, premature battery depletion, intermittent or total loss of telemetry, or no output. There have been no reported patient injuries or deaths due to this issue.
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