Events

Alerte De Sécurité sur Guidant INSIGNIA and NEXUS Implantable Cardiac Pacemakers

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

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
    2005-09-23
  • 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_20050923.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 guidant insignia and nexus implantable cardiac pacemakers september 23, 2005 the department of health has been notified by the guidant corporation of an "important medical device safety information and corrective action" concerning their insignia and nexus implantable cardiac pacemakers. the concerned pacemakers may not function properly without warning and can result in serious health complications, such as syncope which required emergency hospitalization. there have been no reported deaths associated with the malfunction of the affected pacemakers. the manufacturer has advised doctors in hospital authority and private hospitals of this important safety information. there are 115 patients implanted with the affected devices in hong kong and they will be informed by their doctors for follow up actions in a few days' time. the department of health has alerted the hospital authority, private hospitals and medical associations of this safety information.

Device

Guidant INSIGNIA and NEXUS Implantable Cardiac Pacemakers
  • Modèle / numéro de série
  • Description du dispositif
    Press release: Safety Information
  • Manufacturer
    Guidant Corporation

Manufacturer

Guidant Corporation
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DH