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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Notification regarding corrections to labeling related to the cycling feature in some neurostimulation devices used for deep brain stimulation and spinal cord stimulation (scs) therapy. current labeling indicates the use of cycling improves device longevity and recharge interval under all programming scenarios.
Model Catalog: 37612 (Lot serial: All Lots); Model Catalog: 37712 (Lot serial: All Lots); Model Catalog: 37702 (Lot serial: All Lots); Model Catalog: 37021 (Lot serial: All Lots); Model Catalog: 37711 (Lot serial: All Lots); Model Catalog: 37703 (Lot serial: All Lots); Model Catalog: 37704 (Lot serial: All Lots); Model Catalog: 97712 (Lot serial: All Lots); Model Catalog: 37603 (Lot serial: All Lots); Model Catalog: 37602 (Lot serial: All Lots); Model Catalog: 37022 (Lot serial: All Lots); Model Catalog: 97713 (Lot serial: All Lots); Model Catalog: 37713 (Lot serial: All Lots); Model Catalog: 97702 (Lot serial: All Lots); Model Catalog: 37714 (Lot serial: All Lots); Model Catalog: 97714 (Lot serial: All Lots); Model Catalog: 37601 (Lot serial: All Lots)
“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.