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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Livanova is notifying customers that certain model 105 aspirehc and model 106 aspiresr vns therapy generators are subject to the potential for reduced battery longevity associated with the manufacturing process used to assemble the circuit board. physicians of patients with implanted devices are being notified to monitor their impacted patient(s) frequently to check battery status. only model 105 devices were imported and distributed in canada.