LEAD kit for DBS stimulation


  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “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.
  • Manufacturers representative
    Tamer Frères S.A.L.
  • Source

One device with a similar name

Learn more about the data here

  • Model / Serial
    lots: VA15GPJ, VA15K3N, VA15K7K
  • Product Classification
  • Device Class
  • Implanted device?
  • Distribution
    US: AR, CA, FL, IL MD, MO, NE, NY, OH, TN WI.
  • Product Description
    Medtronic, Lead Kit for DBS Stimulation. Model Numbers 3387S-40 (p/n 3387S0007V) & 3389S-40 (p/n 3389S0008V).
  • Manufacturer