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 SA.

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 058 12 16 001
  • Event Initiated Date
    2017-05-16
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=11034
  • 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
    Medtronic identified an issue that may occur with all models of claria mri™ crt-d surescan™ and amplia mri™ crt-d surescan™ devices. the issue is a loss of lv pacing that occurs following a specific device programming sequence. whenever a patient with adaptivcrt* enabled (shipped setting) is subsequently programmed to mvp (managed ventricular pacing) mode and then re-programmed back to ddd or dddr, adaptivcrt is not re-enabled. when this programming sequence occurs, lv pacing is not delivered, despite parameters indicating adaptivcrt is enabled. this will result in rv only pacing which may be undesirable for the patient. lv pacing will remain disabled until a specific programming sequence is manually completed. * this feature adjusts crt parameter values automatically while the patient is ambulatory. if adaptivcrt is programmed to adaptive bi-v and lv, the feature can switch automatically between biventricular pacing and lv-only pacing.

Device

Claria MRI™ CRT-D SureScan™ and Amplia MRI™ CRT-D SureScan™
  • Model / Serial
    Model Name: Product Model - Amplia MRI™ CRT-D SureScan™: ( DTMB2D1, DTMB1D4, DTMB2D4 ) - Amplia MRI™ Quad CRT-D SureScan™: ( DTMB2Q1, DTMB1QQ, DTMB2QQ) - Claria MRI™ CRT-D SureScan™: ( DTMA2D1, DTMA2D4) - Claria MRI™ Quad CRT-D SureScan™: (DTMA2Q1, DTMA2QQ )
  • Product Description
    Cardiac resynchronization therapy implantable defibrillator
  • Manufacturer
    Medtronic SA

Manufacturer

Medtronic SA
  • 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