Events

Field Safety Notices about Cochlear Nucleus 5 System Implant

According to ALIMS (Agencija za lekove i medicinska sredstva), this field safety notices involved a device in Serbia that was produced by Cochlear Limited.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Date
    2011-11-09
  • Event Date Posted
    2011-12-10
  • Event Country
    Serbia
  • Event Source
    ALIMSA
  • Event Source URL
    https://www.alims.gov.rs/latin/2011/10/12/obavestenje-povlacenje-cochlear-nucleus/
  • Notes / Alerts
    Serbian data is current through February 2018. All of the data comes from ALIMS (Agencija za lekove i medicinska sredstva), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and Serbia.
  • Extra notes in the data
  • Reason
    Since a recent increase in the number of nucleus ci512 implant failures was identified, and for precautionary reasons, the manufacturer decided to withdraw these implants from the market until it determined the causes of the problem. in case of implant failure, the recipients can be re-implanted with nucleus freedom series implants. an external device of the series 5, or any series of this manufacturer, is not subject to adverse drug reactions, nor is it subject to market recall.

Device

Cochlear Nucleus 5 System Implant

Manufacturer

Cochlear Limited