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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Purpose of this recall is to provide important safety information regarding the use of the depth stop accessory provided in all medtronic deep brain stimulation (des) lead kits. this notification provides information regarding a product performance issue that has been identified with this component potential risk to patients and actions to take regarding use of the medtronic depth stop. the threaded area of the depth stop does not extend c lose enough to the handle thus preventing it from securing firmly onto the dbs lead during implant. this deficiency may result in the lead being implanted beyond the intended target location which could lead to significant patient consequences.
“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.