Events

Field Safety Notices about VALITUDE™ CRT-P, RESONATE™ CRT-D, MOMENTUM™ CRT-D, AUTOGEN™ CRT-D, INOGEN™ CRT-D, VISIONIST™ CRT-P, VIGILANT™ CRT-D, CHARISMA™ CRT-D, DYNAGEN™ CRT-D, ORIGEN™ CRT-D

According to Ministry of Health, State Institute for Drug Control, Coordination Center for Departmental Medical Information Systems, this field safety notices involved a device in Czechia that was produced by Cardiac Pacemaker Inc – A wholly owned subsidiary of Guidant Corporation – A wholly owned subsidiary of Boston Scientific Corporation.

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
    1572
  • Date
    2018-06-11
  • Event Country
    Czechia
  • Event Source
    MHSIDCCCDMIS
  • Event Source URL
    https://eregpublicsecure.ksrzis.cz/Registr/RZPRO/FSN
  • Notes / Alerts
    Czech data is current through July 2018. All of the data comes from the Czech Public Registry of Medical Devices, 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 the Czech Republic.
  • Extra notes in the data

Device

VALITUDE™ CRT-P, RESONATE™ CRT-D, MOMENTUM™ CRT-D, AUTOGEN™ CRT-D, INOGEN™ CRT-D, VISIONIST™ CRT-...

Manufacturer

Cardiac Pacemaker Inc – A wholly owned subsidiary of Guidant Corporation – A wholly owned subsidi...
  • 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
    MHSIDCCCDMIS