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.
데이터 추가 비고
원인
The version 11 software is unable to detect a catheter fault that occurs due to either an intermittent resistive connection or a thermocouple short proximal to an electrode. when this fault is not effectively detected the displayed temperature will be lower than the actual tissue temperature. if the actual tissue temperature becomes excessive it may result in coagulum and/or char formation during an ablation procedure. formation of coagulum/char is considered a hazardous situation which could lead to patient harm (thrombo-embolic complications).
“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.