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 Boston Scientific Cardiac Rhythm Management Group.

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 094 09 18 000
  • Event Initiated Date
    2018-09-20
  • Event Country
    Saudi Arabia
  • Event Source
    SFDA
  • Event Source URL
    https://ncmdr.sfda.gov.sa/Secure/CA/CaViewRecall.aspx?caid=4&rid=13203
  • 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
    The pacemaker manual describes how increases in pacing requirements or changes in programmed parameters may result in an expected longevity reduction and are considered normal battery depletion. however, hydrogen exposure within the pacemaker’s circuitry may compromise the electrical performance of low voltage capacitors causing current leakage and a moderate acceleration in the rate of battery depletion. because this accelerated depletion does not occur rapidly, a follow-up interval of no more than six months is recommended. boston scientific has determined a liner component to be the source of hydrogen and identified a subset of previously distributed pacemakers that have an elevated potential for exhibiting this behavior. boston scientific pacemakers include automated diagnostic tools, including battery status assessment and estimated longevity predictions, that dynamically adjust based on power consumption. it is important to emphasize that the accuracy of battery status and longevity estimates are not affected by this behavior.

Device

Cardiac Resynchronization Therapy pacemakers (VISIONIST™, ™,) and pacemakers (ACCOLADE™, PROPONE...
  • Model / Serial
    ACCOLADE™ & ACCOLADE™ MRI : L300, L301, L321 & L310, L311, L331 L200, L221 & L210, L211, L231 ESSENTIO™ & ESSENTIO™ MRI : L100, L101, L121 & L110, L111, L131 VISIONIST™ X4 : U228 VALITUDE™ X : 4 U128
  • Product Description
    pacemakers
  • Manufacturer
    Boston Scientific Cardiac Rhythm Management Group

Manufacturer

Boston Scientific Cardiac Rhythm Management Group
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Manufacturers representative
    FAROUK, MAAMOUN TAMER & COMPANY
  • Source
    SFDA