Events

Safety Alert for Commercial Name: Bravo pH Monitoring System / Bravo pH Capsule with Application Device. ANVISA registration number: 10349000438. (Bravo pH Monitoring System) and Capsula Bravo pH with Application Device (10349000435). Risk class: 2. Model (s) affected; and Lot (s) / Serial number (s) affected :. FGS-0312 Bravo® ph capsule delivery device, package with 5. FGS-0313 Bravo® ph capsule delivery device, unit pack

According to Agência Nacional de Vigilância Sanitária (ANVISA), this safety alert involved a device in Brazil that was produced by MEDTRONIC COMERCIAL LTDA.; GIVEN IMAGIN, 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
    1889
  • Date
    2016-04-28
  • 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
    Recommendations to users and patients: The Bravo capsule contains a trocar needle made of stainless steel. Be careful of patients with known sensitivities or allergies to the metals contained, including chromium, nickel, copper, cobalt and iron. The Bravo pH test takes between 48-96 hours.
  • Reason
    Medtronic received three reports from clients related to patients who had allergic reactions to the nickel content contained in the stainless steel trocar needle, which fixed the bravo capsule on the esophageal mucosa. allergic reactions may include hives, itching, or oral numbness. there are no reports of serious injury related to this safety notice.
  • Action
    Action code FA Bravo® pH monitoring. Recommendations for users and patients /// Manual change of instructions

Device

Commercial Name: Bravo pH Monitoring System / Bravo pH Capsule with Application Device. ANVISA re...

Manufacturer

MEDTRONIC COMERCIAL LTDA.; GIVEN IMAGIN, INC.
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    ANVSANVISA