Events

Alerte De Sécurité sur Photon DR (Model V-230HV), Photon Micro VR/DR (Models V-194/V-232), Atlas VR/DR (Models V-199/V-240)

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par St. Jude Medical.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • Date
    2005-10-10
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/press_20051010.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notes supplémentaires dans les données
    Press release
  • Cause
    Safety information regarding st. jude medical implantable cardioverter defibrillators 10 october 2005 the department of health was notified today by the manufacturer of several older generation implantable cardioverter defibrillators that some of its products may be affected by cosmic rays and may not function properly. according to st. jude medical (hong kong) ltd., the affected models are: photon dr (model v-230hv) (certain serial numbers) photon micro vr/dr (models v-194/v-232) atlas vr/dr (models v-199/v-240) no serious patient injury or death has been reported so far. there are totally 34 patients implanted with the affected devices through the public hospitals in hong kong. the supplier has advised the hospital authority of this matter. all the affected patients will be informed by their doctors for follow up actions shortly.

Device

Photon DR (Model V-230HV), Photon Micro VR/DR (Models V-194/V-232), Atlas VR/DR (Models V-199/V-240)
  • Modèle / numéro de série
  • Description du dispositif
    Press release: Safety Information regarding St. Jude Medical Implantable Cardioverter Defibrillators
  • Manufacturer
    St. Jude Medical

Manufacturer

St. Jude Medical
  • 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
    DH