Events

Field Safety Notices about Pacemakers

According to Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), this field safety notices involved a device in Slovenia that was produced by Boston Scientific.

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
    Field Safety Notice
  • Event Country
    Slovenia
  • Event Source
    AMPMDRS
  • Notes / Alerts
    Data from Slovenia is current through February 2019. All of the data comes from the Agency for Medicinal Products and Medical Devices of the Republic of Slovenia (via FOI), 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 Slovenia.
  • Extra notes in the data
  • Reason
    Boston scientific has received reports of occasional over-sensitivity of the minute ventilation (mv) sensor signal at certain boston scientific pacemakers and pacemaker systems for cardiac resynchronization therapy (pacemakers). excessive sensitivity of the mv sensor signal may lead to pre-collapse or collapse due to periods of inhibition. this mv behavior can occur with any manufacturer's pacemaker buses, but boston scientific pacemakers using medtronic or abbott / st. pacemakers are more likely. jude (abbott) guides implanted in right atrium (da) or right ventricle (dp). boston scientific is actively developing a software update that will automatically detect and eliminate the over-sensitivity of the mv sensor signal. we plan to send the software update to regulatory agencies in march 2018, and with their approval, we plan to release it in october 2018. until the software update is available, boston scientific has additional recommendations to prevent this risk in affected pacemaker systems.

Device

Pacemakers

Manufacturer

Boston Scientific
  • 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.”
  • Source
    AMPMDRS