St. Jude Medical Cardiac Rhythm Managment Division || St. Jude Medical Operations || St. Jude Medical Puerto Rico Llc

What is this?

Description

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NIDFSINVIMA
  • 1 Event

One device in the database

  • Model / Serial
    Accent / Anthem , Accent MRI / Accent ST , Assurity / Allure
  • Product Description
    Patients with alterations in the generation and / or conduction of the cardiac electrical impulse. Pulse generators or pacemakers with magnetic resonance imaging (MRI) are conditionally safe in the MRI environment (magnetic resonance imaging) if a complete MRI system is used and in accordance with the instructions for use