Events

Rappel de (1) Evera ICD series (EveraXT ICD DR IS 1 / DF 1 DDBB 2 D 1) (2) Evera ICD series (EveraXT ICD VR IS 1 / DF 4 DVBB 2 D 4) (3) Evera ICD series (Evera XT ICD DR IS 1 / DF 4 DDB B 2 D 4)

Selon Pharmaceuticals and Medical Devices Agency, Japan, ce/cet/cette rappel concerne un dispositif en/au/aux/à Japan qui a été fabriqué par Japan Medtronic Co., Ltd..

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    1-0957
  • Date
    2016-08-16
  • Pays de l'événement
    Japan
  • Source de l'événement
    PMDAJ
  • URL de la source de l'événement
    http://www.info.pmda.go.jp/rgo/MainServlet?recallno=1-0957
  • Notes / Alertes
    Japanese data is current through August 2018. All of the data comes from the Japanese Pharmaceuticals and Medical Devices 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 Japan.
  • Notes supplémentaires dans les données

Device

(1) Evera ICD series (EveraXT ICD DR IS 1 / DF 1 DDBB 2 D 1) (2) Evera ICD series (EveraXT ICD VR...
  • Modèle / numéro de série
  • Description du dispositif
    (1) - (3) Automatic implantable defibrillator
  • Manufacturer
    Japan Medtronic Co., Ltd.

Manufacturer

Japan Medtronic Co., Ltd.
  • 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
    PMDAJ