Events

Recall of Titan Anchor Accessory Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medtronic Neuromodulation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    53689
  • Event Risk Class
    Class 2
  • Event Number
    Z-0500-2010
  • Event Initiated Date
    2009-10-27
  • Event Date Posted
    2009-12-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2011-12-24
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86328
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    stimulator, spinal-cord, totally implanted for pain relief - Product Code LGW
  • Reason
    Medtronic is issuing a medical device correction for the model 3550-39 titan¿ anchor due to the potential for lead migration as a result of insert separation within the anchor. the medtronic model 3550-39 titan¿ anchor accessory kit is designed for use with medtronic percutaneous in-line connector spinal cord stimulation leads. medtronic has received reports of separation of the titanium insert.
  • Action
    Consignees were sent a Medtronic "Urgent: Medical Device Correction" letter on 10/27/09. The letter was addressed to "Dear Healthcare Professional" and was dated October 2009. The letter described the problem and the product as well as the Scope and Potential Severity and gave Recommendations. Enclosures with the letter included: Use By Date (UBD) location on the Titan anchor accessory kit product packaging, Titan anchor patient letter, Reply card and Return envelope. Questions are direct to Medtronic via email at rs.neuroqa1a@medtronic.com.

Device

Titan Anchor Accessory Kit
  • Model / Serial
  • Product Classification
    Neurological Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    All states in the United States including Puerto Rico. Australia, New Zealand, Canada, Andurra, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Netherlands, Ireland, Israel, Italy, Kuwait, Lebanon, Luxembourg, Norway, Portugal, South Africa, Spain, Sweden, Switzerland, Tukey, United Kingdom.
  • Product Description
    Medtronic Accessory Kit , Titan¿ Anchor Accessory Kit, 3550-39, Single Use, RX Only, Contents of the inner package are STERILE., Medtronic, Inc, Minneapolis, MN 55432-5604
  • Manufacturer
    Medtronic Neuromodulation

Manufacturer

Medtronic Neuromodulation
  • Manufacturer Address
    Medtronic Neuromodulation, 7000 Central Ave NE, Minneapolis MN 55432-3568
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • 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.
  • Source
    USFDA