Events

Field Safety Notices about OVATIO / PARADYM / PARADYM 2 / PARADYM RF / INTENSIA devices

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 Sorin Group Italia S.r.l..

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
    1075
  • Date
    2017-04-28
  • 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

OVATIO / PARADYM / PARADYM 2 / PARADYM RF / INTENSIA devices
  • Model / Serial
    Model Number: Model number OVATIO family is constituted by the following models:  OVATIO VR 6250  OVATIO DR 6550  OVATIO CRT 6750 PARADYM ICD/CRT-D family is constituted by the following models: • PARADYM VR 8250 • PARADYM DR 8550 • PARADYM CRT-D 8750 • PARADYM SonR 8770 • PARADYM SonR TriV 8970 PARADYM 2 ICD/CRT-D family is constituted by the following models: • PARADYM 2 VR 8252 • PARADYM 2 DR 8552 • PARADYM 2 CRT-D 8752 • PARADYM 2 SonR CRT-D 8772 PARADYM RF ICD family is constituted by the following models: • PARADYM RF VR 9250 • PARADYM RF DR 9550 • PARADYM RF CRT-D 9750 • PARADYM RF SonR 9770 INTENSIA ICD family is constituted by the following models: • INTENSIA VR 124 • INTENSIA DR 154 • INTENSIA CRT-D 174 • INTENSIA SonR CRT-D 184 Serial Number: All distributed OVATIO / PARADYM/ PARADYM 2 /PARADYM RF/ INTENSIA devices, of which approximately 67,183 have been distributed as of December 31st, 2016.
  • Product Description
    Active implantable medical devices
  • Manufacturer
    Sorin Group Italia S.r.l.

Manufacturer

Sorin Group Italia S.r.l.