Events

Recall of 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
    35110
  • Event Risk Class
    Class 3
  • Event Number
    Z-0861-06
  • Event Initiated Date
    2006-04-04
  • Event Date Posted
    2006-05-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-12-26
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=45370
  • 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
    A specific subset of model 7428 kinetra implantable neurostimulators may fail due to lifted wirebonds between the hybrid circuit and battery. this failure mechanism may present clinically as loss of functionality and a return of the patient's underlying medical conditions.
  • Action
    An Urgent Device Recall Important Patient Management Information letter was sent to implanting and following physicians of patients who have received the device. The letter describes the issue and provides recommendations.

Device

Kinetra Implantable Neurostimulator
  • Model / Serial
    NFD621879S, NFD621891S, NFD621901S, NFD621981S, NFD621976S, NFD622170S, NFD622185S, NFD622189S, NFD622201S, NFD622247S, NFD622279S, NFD623035S, NFD622345S, NFD622349S, NFD622372S, NFD622382S, NFD622387S, NFD622400S, NFD622414S, NFD622466S,  NFD622542S, NFD622564S, NFD622629S, NFD622664S
  • Product Classification
    Neurological Devices
  • Device Class
    3
  • Implanted device?
    Yes
  • Distribution
    USA--States of CA, OR, PA. Internationally -Belgium, France, Germany, Italy, Spain, Switzerland, United Kingdom
  • Product Description
    Medtronic Kinetra 7428. Dual Program Neurostimulator for Deep Brain Stimulation. Rx only. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. Kinetra neurostimulator is a component of the Activa System. The Medtronic Activa System is an implantable, multiprogrammable system that delivers electrical stimulation to selected areas of the brain. The dual program Model 7428 Kinetra Neurostimulator generates electrical signals that are transmitted to the brain. The neurostimulator consists of electronic circuitry and a battery, which are hermetically sealed in a titanium case.
  • Manufacturer
    Medtronic Neurological

Manufacturer

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