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 is updating the model 8870 software application card (to version bbuo1) as well as the synchromed infusion system labeling to address the unintended delivery of drug during the priming bolus function. the synchromed priming bolus function is intended to quickly advance drug from the pump reservoir to the catheter tip to allow for therapy initiation while the patient remains under medical supervision. the updated 8870 software card mitigates the potential for clinically relevant effects of over-delivery of unintended drug such as respiratory depression loss of consciousness or death during the full system priming bolus procedure. the therapy applications on the software card for deep brain stimulation and spinal cord stimulation remain unchanged. this recall affects all 8870 software application cards which are used in the 8840 n'vision clinical programmers. the 8870 software application card is listed under multiple licence numbers which pertain to specific sets of devices that work together.
“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.