Events

Alerte Ou Avis De Sécurité sur Dual Chamber Pacemakers

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 Medtronic Ltd.

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
  • Numéro de l'événement
    MDA/2011/060
  • Date
    2011-06-02
  • Date de publication de l'événement
    2014-12-17
  • 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/medical-device-alert-dual-chamber-pacemakers-confirm-actions-with-manufacturer-after-receipt-of-field-safety-notices
  • 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
    The manufacturer issued a Field Safety Notice (FSN) – Medtronic Reference: FA507 (675Kb) – for these devices on 4 April 2011, but has not had sufficient confirmation from users that they have received and acted on this information.A copy of the FSN is in the appendix of this Alert, and it is also available on the MHRA website.
  • Cause
    (medtronic ltd); manufacturer has not had sufficient confirmation from users that they have received and acted on field safety notice (reference: fa507). (mda/2011/060).
  • Action
    Carry out the actions described in the manufacturer’s FSN, including sending any confirmation requests.

Device

Dual Chamber Pacemakers
  • Modèle / numéro de série
  • Description du dispositif
    Dual Chamber Pacemakers.Medtronic models: Kappa 600, 700, 800 and 900; EnPulse; Adapta; Versa; Sensia; Relia.Vitatron models: E50A1, E60A1 and G70A1.
  • Manufacturer
    Medtronic Ltd

Manufacturer

Medtronic Ltd
  • Adresse du fabricant
    Lezlie Bridge Medtronic Ltd Building 9 Croxley Green Business Park Hatters Lane Watford WD18 8WW Tel: 07740 899 216 Fax: 01923 225 273Email: lezlie.j.bridge@medtronic.com
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “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
    MHRA