Events

Field Safety Notices about InSync® III Cardiac Resynchronization Therapy Pacemakers (CRT-P)

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 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
    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
    Through 27 october 2015, medtronic has confirmed 30 devices (0.03%) worldwide have been impacted by this issue, for which the root cause is unexpected high battery impedance. medtronic records indicate that insync iii devices were shipped to your facility and you may be following one or more patients with an insync iii crt-pacemaker. unexpected high battery impedance can result in the battery’s inability to supply sufficient electrical current, impacting device function. twelve (12) of the 30 devices had reports of unexpected loss of pacing capture. the other 18 devices experienced some form of erratic behavior, including early elective replacement indication (eri), significant fluctuations in remaining longevity estimates, and inaccurate lead impedances. through 27 october 2015, events associated with this issue have occurred in devices with implant durations of 53 months or more. medtronic has received one report of a patient death, where it is possible, but unconfirmed, that this issue was a contributing factor. .

Device

InSync® III Cardiac Resynchronization Therapy Pacemakers (CRT-P)

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.
  • Source
    AMPMDRS