DBS Lead Depth Stop

Manufacturer

  • 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
    Medtronic Saudi Arabia
  • Source
    SFDA

7 devices with a similar name

Learn more about the data here

  • Model / Serial
  • Product Classification
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide Distribution - US including AL, AR, AZ, CA,CO, CT, DC, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN,M MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, and WV. Foreign Distribution: India, ANZ, Taiwan, Hong Kong, Canada, China, Japan, Korea, Malaysia, Philippines, Singapore, Thailand, Indonesia, Vietnam, Albania, Algeria, Austria, Belarus, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, India, Iran, Iraq, Israel, Italy, Jordan, Kazakhstan, Kuwait, Latvia, Lebanon, Libya, Lithuania, Luxembourg, Malta, Morocco, Netherlands, Norway, Pakistan, Poland, Portugal, Romania, Russian Federation, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, Ukraine, United Arab Emirates, United Kingdom, Argentina, Brazil, Chile, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Mexico, Panama, Peru, Puerto Rico, Uruguay, and Venezuela.
  • Product Description
    DBS Lead Depth Stop contained in Medtronic Deep Brain Stimulation (DBS) lead kits, models 3387/3387S, 3389/3389S, and 3391/3391S, The lead kit contains one DBS lead in addition to multiple accessories used in DBS lead implant procedures. Among these accessories is the DBS lead holder, also referred to as the lead depth stop. || The lead holder affixes to the DBS lead during the lead implant procedure, marking the distance to the lead tip and providing control of DBS lead depth during implant by interfacing with the stereotactic system
  • Manufacturer
  • Model / Serial
  • Product Description
    DBS LEAD DEPTH STOP FOR MEDTRONIC DBS LEAD KIT FOR STIMULATION OF THE BRAIN, Medtronic Inc.
  • Manufacturer
  • Model / Serial
    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
  • Product Classification
  • Manufacturer
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