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 St. Jude Medical 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 002 04 12 000
  • Event Initiated Date
    2012-04-03
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=1633
  • 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
    St. jude medical received reports of therapy degradation associated with a small number of brio ipgs at a very limited number of hospitals. an analysis of returned devices found that fluid had intruded into the ipg header assembly leading to diminished or loss of therapy. septum damage, which can occur during implant, was found in a majority of the explanted devices and can contribute to fluid intrusion into the ipg header assembly. we are taking a proactive approach by issuing a voluntarily field corrective action for the brio ipg and implementing improvements to the product.

Device

Implants, active, stimulators, neuro, BRIO IPG (MODEL 6788)
  • Model / Serial
    MODEL 6788
  • Product Description
    Implants, active, stimulators, neuro, Implantable Pulse Generators (Spinal Cord Stimulator) & (Deep Brain Stimulator).
  • Manufacturer
    St. Jude Medical Inc.

Manufacturer

St. Jude Medical Inc.
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Manufacturers representative
    Al-Jeel Medical & Trading Co. LTD
  • Source
    SFDA