“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.
The MEDTRONIC model 6416 temporary transvenous stimulation cable system has a bipolar active fixation cable and a lubri- cated lubricant guide catheter. This system has been designed for temporary intracardiac stimulation and the recording of electrocardiograms. It is a disposable system, for temporary use with only one patient, with an estimated implant duration of 7 days or less.