Events

translation missing: en.activerecord.attributes.event.titles.recall_field_safety_notice

According to Saudi Food & Drug Authority, this translation missing: en.activerecord.attributes.event.types.recall_field_safety_notice involved a device in Saudi Arabia that was produced by Cyberonics 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
    Recall / Field Safety Notice
  • Event ID
    mdprc 096 12 15 000
  • Event Initiated Date
    2015-12-23
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=8668
  • Notes / Alerts
    Saudi data is current through January 2019. All of the data comes from the Saudi Food & Drug Authority, 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 Saudi Arabia.
  • Extra notes in the data
    Report Source: NCMDR
    SFDA urges all hospitals that have devices subjected to recall, to contact the company.
  • Reason
    Due to unintended behavior in the model 106 aspiresr generator software, the generator can stop delivering stimulation unexpectedly. this event can only occur when a rare combination of circumstances are present, one of which is when the autostim output current is programmed greater than or equal to the magnet output current. stimulation can be reinitiated at the next office visit by programming stimulation output current on.

Device

Model 106 AspireSR® VNS Therapy® generator
  • Model / Serial
    Error message displayed upon interrogation of M106 Generator after event
  • Product Description
    VNS Therapy
  • Manufacturer
    Cyberonics Inc

Manufacturer

Cyberonics Inc
  • Manufacturer Parent Company (2017)
    LivaNova PLC
  • Manufacturers representative
    Gulf Medical Co.
  • Source
    SFDA