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 Cardiovascular Revascularization & Surgical Therap.

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 057 05 16 000
  • Event Initiated Date
    2016-05-09
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=9332
  • 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 has confirmed four (4) instances of loss of therapy during recharging of a restoresensor implantable neurostimulator, for a rate of 0.007% (4 / 54.516) of devices distributed worldwide. by design, stimulation therapy turns off when battery voltage depletes below 3.575 volts. in the reported occurrences, a charging session was terminated prior to obtaining a recharge threshold voltage of 3.615, which triggered a rapid battery depletion state. as a result of the rapid battery discharge state, the implanted neurostimulators depleted to 1.925 volts (a state of overdischarge) in one to two days rather than the typical 30 days. insufficient coupling (charging efficiency) between the recharger and the implanted neurostimulator during the recharge session was found to be a key factor in the reported events. note that once a device is in the over discharge state, therapy is interrupted with return of patient symptoms and can only be restored using the physician recharge mode of the recharger. as described in labeling, if three occurrences of overdischarge occur, the neurostimulator will trigger end of life, and must be replaced to resume therapy.

Device

Neurostimulator system for pain therapy

Manufacturer

Medtronic Cardiovascular Revascularization & Surgical Therap
  • 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
    Gulf Medical Co.
  • Source
    SFDA