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 information concerning potential lead damage due to the use of lead cap provided in the medtronic deep brain stimulation (dbs t) lead kits. medtronic has received reports of dbs leads being damaged at the connector end of the lead when the lead cap is used. the connector end of the lead is the end of the lead connected to the lead extension. tightening or loosening of the setscrew may twist the setscrew connector block and may damage the proximal connector end of the lead. if this happens the damage would most likely occur at lead contact #3 which could affect electrode contact #3 and it may also become difficult to loosen the screw and remove the lead from the lead cap. depending on the extent of lead damage and the need to use electrode #3 lead replacement may be required or optimal therapy may not be provided. lead damage due to setscrew connector block twisting has been reported with 0.25% of the dbs leads distributed however this incidence is lower than the expected actual rate of occurrence since every event is not likely to have been reported and the actual number of uses of lead caps is unknown. physicians should recognize that every use of the lead cap provides an opportunity for lead damage to occur. to date there have been no reports of permanent patient impairment life-threatening injury or death as a result 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.