Events

Field Safety Notices about INOGEN CRT-D

According to Swiss Agency for Therapeutic Products, this field safety notices involved a device in Switzerland that was produced by Cardiac Pacemaker Inc.

What is this?

Field safety notices are communications sent out by medical device manufacturers or their representatives in relation to actions that they may be taking in relation to their product that is on the market. These are mainly for health workers, but also for users. They can include recalls and alerts.

Learn more about the data here
  • Type of Event
    Field Safety Notice
  • Event ID
    Vk_20171213_13
  • Event Date Posted
    2017-12-20
  • Event Status
    2017-12-20
  • Event Country
    Switzerland
  • Event Source
    SATP
  • Event Source URL
    https://fsca.swissmedic.ch/mep/#?q=Vk_20171213_13
  • Notes / Alerts
    The data from Switzerland is current through March 2018. All of the data comes from Swiss Agency for Therapeutic Products, 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 Switzerland.
  • Extra notes in the data

Device

INOGEN CRT-D
  • Model / Serial
    G140, G141, G146, G148 | All
  • Product Description
    AIMD: Cardiac resynchronization therapy implantable defibrillator
  • Manufacturer
    Cardiac Pacemaker Inc

Manufacturer

Cardiac Pacemaker Inc
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    SATP