Events

Safety Alert for CARDIOVERSOR DEFIBRILLADOR IMPLANTÁVEL TELIGEN 100, Model E102 (Anvisa registry n ° 10341350535); CARDIOVERSOR IMPLANTABLE DEFIBRILLATOR 100 OF DUAL CAMERA, Model E110 (Anvisa registry nº 10341350534); and COGNIS 100 IMPLANTABLE RESSINCRONIZER DESFIBRILLATOR, Model N119 (Anvisa registration n ° 10341350536).

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by Boston Scientific do Brasil Ltda..

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
    1106
  • Date
    2011-12-20
  • 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
    See details in attached file.
  • Reason
    Update of information regarding electrode shock impedance test.
  • Action
    Boston Scientific do Brasil Ltda has initiated field action to inform customers that, from now on, they should contact the Company's Technical Service to obtain the measured electrode impedance value (up to 200 ohms), in the event of an alert for electrode.

Device

CARDIOVERSOR DEFIBRILLADOR IMPLANTÁVEL TELIGEN 100, Model E102 (Anvisa registry n ° 10341350535);...

Manufacturer

Boston Scientific do Brasil Ltda.
  • Source
    ANVSANVISA