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 communicates recent results from returned product analysis of medtronic neuromodulation deep brain stimulation (dbs) system pocket adaptors with reports of high impedances and reinforces device labeling specific to the handling of pocket adaptors and system integrity checking during implant procedures. medtronic has identified sixteen (16) dbs pocket adaptors that were returned for high impedance measurements and where subsequent medtronic analysis identified conductor wire fractures in close proximity to the location where the adaptor wire exits the neurostimulator connector block. notification raises awareness of current product labeling that could reduce potential for pocket adaptor conductor wire fractures or increase detection of an issue during the implant procedure.
“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.