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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Spacing between zig-zag wire and insulation is too long (10mm instead of 2mm). the defects affects the proper placement of zig-zag into the heart wall and subsequent electrical contact might be compromised.