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 Medtronic.

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 098 06 18 000
  • Event Initiated Date
    2018-06-27
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=12806
  • 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
    There is a potential for loss of high voltage and anti-tachycardia pacing therapy in entrust and escudo implantable cardioverter defibrillators (icds) as they near elective replacement indicator (eri) voltage. under certain circumstances, the device may display an immediate end of life (eol) observation with no prior eri alert. though no eri alert is triggered, there may not be enough remaining battery capacity to charge the high voltage circuits, resulting in an excessive charge time eol observation (refer to image 1 in appendix a in the attached fsn), leading to a loss of high voltage and anti-tachycardia pacing therapy. bradycardia therapies will continue to operate as expected.

Device

EnTrust and Escudo VR/DR/AT ICDs
  • Model / Serial
    EnTrust and Escudo VR/DR/AT ICDs
  • Product Description
    implantable cardioverter defibrillators (ICDs)
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • Manufacturer Parent Company (2017)
    Medtronic plc
  • Manufacturer comment
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Manufacturers representative
    Medtronic Saudi Arabia
  • Source
    SFDA