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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On a subset of platimium icd or crt-d df4 models a component of the df4 connector was identified as potentially defective leading to intermittent loss of contact. as a consequence high values of continuity measures on the defibrillation coils or noise on the right ventricular channel may be observed. this issue can also lead to absence of ventricular pacing therapy and/or inappropriate shock. delivery of defibrillation shock is unaffected.