Events

Safety Alert Or Field Safety Notices for Implantable pulse generators (IPGs) neurostimulators

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
  • Event Number
    MDA/2011/079
  • Date
    2011-07-13
  • Event Date Posted
    2014-12-17
  • Event Country
    United Kingdom
  • Event Source
    MHRA
  • Event Source URL
    https://www.gov.uk//drug-device-alerts/medical-device-alert-implantable-pulse-generators-ipgs-neurostimulators-confirm-actions-from-field-safety-notice
  • 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
    Faulty battery components have resulted in some IPGs losing the ability to communicate with the programmer or recharge. In the cases reported, the duration between recharges became progressively shorter until the IPG failed to charge or there was a sudden loss of power, which resulted in the need for device replacement. The time from manufacture of affected devices to explant has so far ranged from eight months to two years.
  • Reason
    (st jude medical) manufacturer not received sufficient confirmation of action after a field safety notice was sent out on the faulty battery components that could result loss in ability to communicate with the programmer or recharge in some ipgs. (mda/2011/079).
  • Action
    Read the manufacturer’s Field Safety Notice (FSN) (226Kb) Identify affected patients using the list of serial numbers within the FSN Review affected patients and advise them to contact their clinician immediately in the event of a sudden loss of device power Patients fitted with devices that are noted to have a shorter duration between recharges should be considered for a replacement device on an individual

Device

Implantable pulse generators (IPGs) neurostimulators
  • Model / Serial
  • Product Description
    Implantable Pulse Generators (IPGs) – Neurostimulators. Eon Mini™ (Model 65-3788) and Brio™ (Model 65-6788).Manufactured by St Jude Medical.
  • Manufacturer
    St Jude Medical

Manufacturer

St Jude Medical
  • Manufacturer Address
    Sean Hogarth St Jude Medical UK Ltd Capulet House Stratford Business and Technology Park Stratford Upon Avon CV37 7GX Tel: 01789 207 611 Fax: 01789 207 601Email: SHogarth@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