Trade name: DBS ELETRODE FOR DEEP BRAIN STIMULATION; DEEP BRAIN STIMULATION ELECTRODE; KIT CATETER DBS ELECTRODE FOR DEEP BRAIN STIMULATION Technical name: DBS ELETRODE FOR DEEP BRAIN STIMULATION; DEEP BRAIN STIMULATION ELECTRODE; KIT CATETER DBS ELECTRODE FOR DEEP BRAIN STIMULATION ANVISA registration number: 10339190484; 10339190549; 10339190339 Hazard Class: IV Affected Model: 3387S-40, 3389S-28, 3389S-40 and 3391S-40
“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.