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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The purpose of this action is inform physicians who have implanted or follow patients implanted with dual chamber pacemakers about a rare approximately 1 in 18000 devices measurement lock-up condition that may inappropriately trigger eri/rrt in specific medtronic dual chamber pacemakers. in rare instances these devices exhibit a condition in which the hardware component of the measurement system may lock up resulting in the device declaring eri (elective replacement indicator)/rrt (recommended replacement time). this device then inappropriately defaults to an eri state. when devices exhibit this condition they do not actually have a depleted battery but rather the device displays eri due to the erroneous voltage measurement. when the false eri occurs the device is reverted to a defined set of parameters (vvi mode at 65 beats per minute). a device exhibiting thiscondition can be resolved through the use of a specially configured programmer and software reset application to clear the eri/rrt condition. the ipg is not modified but simply returned to its previous settings. it should be noted that this issue does not shorten the actual device longevity after a reset.
“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.