Events

Field Safety Notices about Orsiro, Sirulismus Eluting Coronary Stent System

According to Bundesinstitut für Arzneimittel und Medizinprodukte, this field safety notices involved a device in Germany that was produced by Biotronik AG.

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
    03984/15
  • Date
    2015-06-25
  • Event Country
    Germany
  • Event Source
    BAM
  • Event Source URL
    https://www.bfarm.de/SharedDocs/Kundeninfos/EN/11/2015/03984-15_kundeninfo_en.html
  • Notes / Alerts
    German data is current through October 2018. All of the data comes from Bundesinstitut für Arzneimittel und Medizinprodukte, 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 Germany.
  • Extra notes in the data

Device

Orsiro, Sirulismus Eluting Coronary Stent System
  • Model / Serial
  • Implanted device?
    Yes
  • Product Description
    Non-active implants - special implants
  • Manufacturer
    Biotronik AG

Manufacturer

Biotronik AG
  • Manufacturer Parent Company (2017)
    Ms Holding Ii Se
  • Manufacturer comment
    Biotronik told ICIJ that, when it identifies the need to issue a recall, the company immediately informs physicians of all potentially affected patients. It also noted that product recalls for all manufactures are publically available on the relevant national authorities’ websites. “As soon as an event is deemed serious either by a hospital or a manufacturer, it is reported inter alia to the regulatory authority in the country in which the incidence has occurred, as well as to the FDA for US-approved devices, even if the event has occurred outside of the US,” the company said.
  • Source
    BAM