Events

Avis De Sécurité sur Ellipse VR/DR ICD

Selon Swedish Medical Products Agency, ce/cet/cette avis de sécurité concerne un dispositif en/au/aux/à Sweden qui a été fabriqué par St. Jude Medical CRMD.

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
    Field Safety Notice
  • ID de l'événement
    6.6.4-2014-66557
  • Pays de l'événement
    Sweden
  • Source de l'événement
    SMPA
  • URL de la source de l'événement
    https://lakemedelsverket.se/malgrupp/Halso---sjukvard/Medicinteknisk-sakerhetsinformation/fran-tillverkare/FSN2014/Aktiva-implantat--Ellipse-VRDR-ICD--St-Jude-Medical-CRMD/#
  • Notes / Alertes
    Swedish data is current through 2018. All of the data comes from the Swedish Medical Products 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 data from the U.S. and Sweden.
  • Notes supplémentaires dans les données
    OQLUM4861
  • Action
    Information on the risk of use. Products should be revoked. Follow-up patient.

Device

Ellipse VR/DR ICD
  • Modèle / numéro de série
  • Dispositif implanté ?
    Yes
  • Description du dispositif
    Active implant
  • Manufacturer
    St. Jude Medical CRMD

Manufacturer

St. Jude Medical CRMD
  • 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
    SMPA