Events

Safety Alert for implantable pulse generator Barostim

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by CVRX 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
    I1602-40
  • Event Number
    2015DM-0014000
  • Date
    2016-02-03
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=158
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer reports that he has made a correction in the documentation of the device, referring to the risk of exposing the device to nuclear resonance imaging (mri), this situation can cause a permanent interruption of communication with the programmer, leading to potential adverse events for patients. .

Device

implantable pulse generator Barostim
  • Model / Serial
    2102 and 9010
  • Product Description
    Indicated for patients with heart failure or resistant hypertension that is defined as: arterial-systolic pressure of 140mmhg or higher, and maximum treatment resistance tolerated with a diuretic and two other antihypertensive drugs. Heart failure is defined as functional III according to the cardiological association of New York and with left ventricular ejection fraction (LVEF) 35% despite treatment in the manner indicated by the guideline for adequate heart failure.
  • Manufacturer
    CVRX Inc

Manufacturer

CVRX Inc
  • Manufacturer Parent Company (2017)
    CVRx Inc.
  • Source
    NIDFSINVIMA