Canadian data is current through March 2018. All of the data comes from Health Canada, except for the categories Manufacturer Parent Company and Product Classification.
The Parent Company and the Product Classification were added by ICIJ.
The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Canada.
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Sorin is notifying users of the overestimation of residual longevity displayed by orchestra and orchestra plus programmers during follow-up exams of patients implanted with reply and esprit rate responsive pacemakers. because of the incorrect information the follow-up dates might not have been adjusted when nearing the eri (elective replacement indicator). when the device approaches the eri this overestimation could result in eri or eol (end of life) being reached between two follow-up visits.