Events

Recall of Device Recall Medtronic Kinetra Implantable Neurostimulator

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

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
    35967
  • Event Risk Class
    Class 2
  • Event Number
    Z-0290-2007
  • Event Initiated Date
    2006-07-19
  • Event Date Posted
    2006-12-19
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-04-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=47276
  • 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
    neurostimulator - Product Code MHY
  • Reason
    A subset of kinetra implantable neurostimulators may experience a failure of wire connections between the electronic hybrid circuit and battery which may lead to sudden cessation of therapy. sudden cessation of therapy can result in the immediate return or worsening of underlying symptoms due to the progression of the disease state.
  • Action
    Letter dated July 2006. Recommendations were made to Health Care Providers of the following: 1.Consider the potential for this anomaly if your patient present with a device in a POR state. 2. Consider informing your patients of this risk and advise them to seek attention immediately if they experience a return of pre-implant or more advanced symptoms. 3. Determine whether device replacement is warranted based upon consultation with your patient, review of the patient''s medical history and consideration of the relative risks of abrupt cessation of stimulation versus the risk of a device replacement surgical procedure. 4. Report any malfunction, removal and replacement to Medtronic and FDA suing the medical device reporting system. 5. Acknowledge this communication using the reply form enclosed.

Device

Device Recall Medtronic Kinetra Implantable Neurostimulator
  • Model / Serial
    serial numbers in the following ranges:   ¿ NFD100006 - NFD100325H ¿ NFD620017S - NFD625737S ¿ NFD200201K - NFD201303K
  • Product Classification
    Neurological Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    Worldwide, including USA, Puerto Rico, Australia, Austria, Belgium, Canada, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Iceland, India, Israel, Italy, Jordan, Lebanon, Luxembourg, Netherlands, Norway, Poland, Portugal, Russia, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom.
  • Product Description
    Medtronic Kinetra Dual Program Neurostimulator for Deep Brain Stimulation, model 7428. Rx only. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. The dual program model 7428 Kinetra Neurostimulator generates electrical signals that are transmitted to the brain. These signals are delivered from the neurostimulator to the brain via DBS extension or DBS leads. The neurostimulator consists of electronic circuitry and a battery, which are hermetically sealed in a titanium case. The operation of the neurostimulator is supported by a clinician programmer, a therapy controller, and a control magnet.
  • Manufacturer
    Medtronic Neurological

Manufacturer

Medtronic Neurological
  • Manufacturer Address
    Medtronic Neurological, 800 53rd Ave NE, PO Box 1250, Minneapolis MN 55440-1250
  • Source
    USFDA