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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In rare instances a system diagnostic test using model 250 programming software (v 7.1 and earlier) may report "lead impedance: ok" when in fact normal wear and trauma has resulted in a short-circuit condition that prevents the lead from delivering therapy to the vagus nerve.
Model Catalog: 250 (VERSIONS 6.1 AND LESS) (Lot serial: ALL VERSIONS AND LOT NUMBERS); Model Catalog: 250 V7.1.4 (Lot serial: ALL VERSIONS AND LOT NUMBERS); Model Catalog: 250 (Lot serial: ALL VERSIONS AND LOT NUMBERS)