Events

Recall of Model 5348 Single-Chamber External Pulse Generator

According to Department of Health, Therapeutic Goods Administration, this recall involved a device in Australia that was produced by Medtronic Australasia Pty Ltd.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    RC-2014-RN-00495-1
  • Event Risk Class
    Class I
  • Event Initiated Date
    2014-05-08
  • Event Country
    Australia
  • Event Source
    DHTGA
  • Event Source URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2014-RN-00495-1
  • Notes / Alerts
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Extra notes in the data
  • Reason
    Medtronic has identified the development of high resistance on internal electrical connector contacts due to oxidation over time. due to the unpredictable nature of the oxidation process on multiple electrical contacts, this issue may result in one or more of the following: • pacing rate outside of the intended setting, potentially including a sudden increase in pacing rate up to the maximum setting of 180 ppm. • output amplitude or sensitivity outside of intended setting. • pace, sense, or low battery led indicators not lighting during power on or reset functions. • rapid atrial pacing (rap) display with intermittent functionality. • intermittent functionality of the on/off and rap control buttons.
  • Action
    Medtronic recommends that the following actions be taken when using a potentially affected Model 5348 EPG: • Monitor the EPG function and patient’s heart rhythm continuously while the EPG is in use to ensure it is operating properly and delivering appropriate therapy to the patient. • If any malfunction is observed with a 5348 EPG, ensure the patient’s condition is stabilized, discontinue use of the Model 5348 device and contact your Medtronic representative. During the design and development of new models, Medtronic identified that a service life of five years is most appropriate for an External Pulse Generator. Therfore, Medtronic is advising customers that they will no longer provide standard servicing of EPGs (calibration, physical inspection or repair) that are more than five years old including these potentially affected 5348 EPGs. Continued use of the device will require end users to perform the relevant maintenance procedures to ensure safe and effective operation of the devices.

Device

Model 5348 Single-Chamber External Pulse Generator

Manufacturer

Medtronic Australasia Pty Ltd
  • 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
    DHTGA