Events

Safety Alert Or Field Safety Notices for Four Bipolar QuickSite and QuickFlex lead models

According to Medicines and Healthcare products Regulatory Agency, this safety alert or field safety notices involved a device in United Kingdom that was produced by St Jude Medical.

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
    Safety alert / Field Safety Notice
  • Date
    2012-06-21
  • Event Date Posted
    2016-06-21
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/four-bipolar-quicksite-and-quickflex-lead-models-risk-of-worsening-heart-failure-symptoms-due-to-wear-and-or-abrasion-of-lead-insulation-after-implantation
  • Notes / Alerts
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, 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 the United Kingdom.
  • Extra notes in the data
  • Reason
    Change to 2012 advice – current data supports the withdrawal of mda/2012/021 and reversion to normal 6-monthly patient follow-up, combined with the remaining advice already given, listed under action.
  • Action
    Return patient follow-up to the standard practice of reviewing lead performance at 6-monthly intervals, following your own standard procedures. Prophylactic replacement of these devices is not recommended except in exceptional circumstances. Ensure all patients are enrolled on remote monitoring where possible, in discussion with St Jude Medical.

Device

Four Bipolar QuickSite and QuickFlex lead models

Manufacturer

St Jude Medical
  • Manufacturer Address
    St Jude Medical UK Ltd Tel: 01789 207637 Email: rback@sjm.com
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    MHRA