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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As of december 31 2012 sorin has confirmed 30 instances out of 13500 units implanted worldwide (0.222%) where the analysis of the returned leads identified internal insulation breach under the right ventricular (rv) and/or superior vena cava (svc) defibrillation coil electrode resulting in low pacing impedance and/or ventricular oversensing and/or inappropriate therapies. no permanent serious injury or death has been reported as a result of the confirmed malfunction.