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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This action is being conducted due to the potential for a breach in the sterile packaging due to damage that may have occurred during transportation. this removal is intended to mitigate the risk for infection as a result of a potential breach in the sterile packaging. while the primary peripheral nerve evaluation (pne) lead and cable components have an additional sterile barrier separate from the tray additional kit components used during the pne lead implant procedure do not. through 12 february 2016 medtronic has not received any complaint reports related to this issue.
“If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.