Events

Safety Alert for Deep brain stimulation electrode kits: (1) Model 3387, (2) Model 3389. all lot numbers

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

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
    330
  • Date
    2001-11-09
  • 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
    UNTIL THIS DATE DOES NOT CONSERT PRODUCT REGISTRATION IN BRAZIL
  • Reason
    Some electrodes in the above stimulation kits are not attached to a connector. the manufacturer commenced removal by letter dated january 16, 2001.
  • Action
    Check receipt of the letter dated January 16, 2001 from Medtronic. Identify and isolate all affected products in your inventory. The manufacturer states that all products that were not implanted were recovered and that all physicians who implanted the stimulators were notified. ECRI recommends that you determine if any of the above units have been deployed in your institution and by whom. Enter the name of the doctor who implanted the product that was removed. The implantologist must decide whether a medical intervention is necessary in patients who have already undergone the implant. Medtronic does not recommend withdrawal of an already implanted product. She states that the error can be controlled and does not recommend implant removal or re-intervention. For more information, contact your local representative or directly with Medtronic at 1 (612) 514-5000 in the United States. Notify any occurrences associated with these products, to ANVISA, Technovigilance Unit, filling out the Health Product Associated Notifications Form available on the Internet http://www.anvisa.gov.br/tecnovigilancia and send directly online or save the file completed and send by e-mail tecnovigilância@anvisa.gov.br, or print it and send by fax 0xx61-4481257

Device

Deep brain stimulation electrode kits: (1) Model 3387, (2) Model 3389. all lot numbers

Manufacturer

Medtronic Inc
  • Source
    ANVSANVISA