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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The investigation report (ir) for synchromed ii pump corrosion defines the problem statement as the "degradation of synchromed ii motor components due to corrosion wear and a combination of corrosion and wear can result in temporary intermittent and/or permanent motor stall." the root cause of failure is identified as the depletion of lubricant at the shaft/jewel bearing interface which initiates mechanical wear on shaft ends resulting in wear particles that can mix with the remaining lubricant creating residue. shaft wear results in temporary or permanent motor stall.
“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.