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 model 5392 epgs could experience a performance issue when used with specific aa-sized (lr6) batteries. medtronic has received six (6) reports (out of approximately 6000 model 5392 epgs distributed globally) where the negative terminal of a commercially available aa (lr6) battery did not maintain a sufficient connection with the battery drawer electrical contact. this issue could prevent the epg from powering on or cause the epg to abruptly lose primary battery power potentially stopping delivery of pacing therapy. there have been no reports of patient harm as a result of any occurrence of this issue.
“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.