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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Medtronic has identified a compliance issue with model 6416 temporary transvenous pacing lead system. the product is not compliant with section 8.5.2.3 of iec 60601-1 and corresponding provisions of fda 21 cfr 898 which relate to design standards to prevent connecting a patient's lead to a possible hazardous voltage. through 02-jun-2016 medtronic has received zero (0) reports of adverse patient effects from misuse of the 6416 lead by connecting it to a potentially hazardous voltage. this recall is being taken to prevent this unlikely potential misuse of the 6416 lead.
“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.