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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During the use of some atar extension cables the cable was seperating from the connector at the proximal end. analysis revealed that the connector and wire separation was attributed to a fracture of the conductor cable malfunction causing interruption of the pacing system. the cause for the failure are attributed to a combination of manufacturing process and field misuse of the cables.