Events

Alerte Ou Avis De Sécurité sur Four Bipolar QuickSite and QuickFlex lead models

Selon Medicines and Healthcare products Regulatory Agency, ce/cet/cette alerte ou avis de sécurité concerne un dispositif en/au/aux/à United Kingdom qui a été fabriqué par St Jude Medical.

Qu'est-ce que c'est?

Les avis de sécurité sont des communications que les fabricants de dispositifs médicaux ou leurs représentants font parvenir en particulier aux travailleurs du secteur médical, mais aussi aux utilisateurs de ces dispositifs. Les avis de sécurité concernent les actions entreprises quant aux dispositifs présents sur le marché et peuvent inclure des rappels et des alertes.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert / Field Safety Notice
  • Date
    2012-06-21
  • Date de publication de l'événement
    2016-06-21
  • Pays de l'événement
    United Kingdom
  • Source de l'événement
    MHRA
  • URL de la source de l'événement
    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 / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Adresse du fabricant
    St Jude Medical UK Ltd Tel: 01789 207637 Email: rback@sjm.com
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “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