“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 computer-assisted surgery system and its associated applications were designed to help locate anatomical structures and plan surgical trajectories in open and percutaneous interventions. Its use is indicated for any clinical disorder for which it is considered appropriate to use stereotactic surgery and where it can establish a reference to a rigid anatomical structure in relation to diagnostic images of the anatomy.