Events

Recall of Medtronic DBS Extension Kit for

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
    71016
  • Event Risk Class
    Class 2
  • Event Number
    Z-1617-2015
  • Event Initiated Date
    2015-04-16
  • Event Date Posted
    2015-05-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-07-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135848
  • 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, electrical, implanted, for parkinsonian tremor - Product Code MHY
  • Reason
    Medtronic is providing important information regarding extension handling during implant procedure after receiving reports of high impedances. this applies to extension models 37085 and 37086 which can be used with the following implantable neurostimulators: activa¿ pc (model 37601), activa¿ rc (model 37612), and the activa¿ sc (model 37603).
  • Action
    Medtronic began notifying consignees with an Urgent Medical Device Safety Notification letter beginning April 16, 2015. Consignees will be notified by mail and/or in person, by visit of a Medtronic field representative. The letter described the issue and provided recommendations of following the instructions defined within the Neurostimulator implant manual. A Physician Reply Form was asked to be returned via fax at 800-897-3899 or email to neuro.quality@medtronic.com. Consignees with questions can contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7am - 6pm CST.

Device

Medtronic DBS Extension Kit for
  • Model / Serial
    all Serial numbers
  • Product Classification
    Neurological Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    worldwide
  • Product Description
    Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
  • 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