DBS Lead Depth Stop DBS Lead Depth Stop supplied with Medtronic Models 3387, 3389 and 3391
모델명 / 제조번호(시리얼번호)
DBS Lead Depth StopDBS Lead Depth Stop supplied with Medtronic Models 3387, 3389 and 3391All leads with a use by date of 2021-03-01 or earlierARTG Numbers: 137374, 137138 and 174469 respectively
“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.