Events

Safety Alert for COCHLEAR IMPLANT. . Cochlear implants are medical devices that convert sound signals into electrical signals, which allow direct stimulation of the auditory nerve fibers through an electrode implanted in the cochlea.

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by N/A.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event ID
    664
  • Date
    2002-08-01
  • Event Country
    Brazil
  • Event Source
    ANVISA
  • Event Source URL
    http://www.anvisa.gov.br/sistec/alerta/consultaralerta.asp
  • Notes / Alerts
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Extra notes in the data
    Following these events, one of the cochlear implant manufacturers of ADVANCED BIONICS CORPORATION voluntarily suspended the commercialization of the AB-5100 H11 (Hifocus I electrode) and AB-5100 H12 (HiFocus II electrode) of the CLARION brand. BRAZIL - August 23, 2002 - The National Agency of Sanitary Surveillance / ANVISA, has detected the existence of a similar product registered in Brazil and is investigating if there is any relation of this with the aforementioned product.
  • Reason
    The national institute of pharmacy and medicines (infarmed) was aware of the occurrence of 25 reports worldwide (with a higher incidence in europe) of bacterial meningitis potentially associated with the use of this product.
  • Action
    In order to safeguard Public Health and to prevent the occurrence of bacterial meningitis in individuals with cochlear implants, INFARMED recommends that: "Centers responsible for implanting this type should inform individuals with cochlear implants (or their parents, in the case of of the main signs and symptoms of meningitis and that the same individuals are urged that if they detect the presence of the same signs or symptoms, urgently contact their attending physician and also that the history of vaccination for pneumococci and Haemophilus influenzae serotype B and that, if it has not been done, the hypothesis of vaccination of the individuals with cochlear implants, as well as the candidates to carry out this type of intervention be considered "

Device

COCHLEAR IMPLANT. . Cochlear implants are medical devices that convert sound signals into electri...
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    ANVSANVISA