Events

Alerte De Sécurité sur Implantable Automatic Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT-D)

Selon National Drugs Administration from El Salvador (DNM), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à El Salvador qui a été fabriqué par N/A.

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
  • Classe de risque de l'événement
    Class I
  • Date
    2016-10-11
  • Pays de l'événement
    El Salvador
  • Source de l'événement
    DNM
  • URL de la source de l'événement
    https://www.medicamentos.gob.sv/index.php/es/servicios-m/ciudadanos/alertas-dnm/alertas-sanitarias-internacionales
  • Notes / Alertes
    Data from El Salvador is current through April 2018. All of the data comes from the National Drugs Administration from El Salvador (DNM), 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 El Salvador.
  • Notes supplémentaires dans les données
  • Cause
    The cause of the alert is the premature exhaustion of the battery causing that patients do not have the normal waiting time of three months for the replacement of the device, some batteries have been exhausted within 24 hours after the patient receives an alert eri (elective substitution indicator). the distributor's facilities were visited and the import documents for the year 2013-2016 were reviewed, finding 4 teams whose model numbers are in accordance with the health alert. for which follow-up was done, identifying the doctors who performed the implantation procedure so that they could contact the patients, this communication was made by the health professionals and a control was planned for the patients.
  • Action
    Professionals and health centers are advised to stop immediately using the products described in the health alert and to demand from the supplier of the same the action plan to solve said defect or the withdrawal of the product. Notice to the population recomending not to use the product and inform the National Drugs Administration about the commercialization, distribution or dispensation of this product within any health establishment. - Make searches of the product in health centers and establishments that are dedicated to the sale of medical devices

Device

Implantable Automatic Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT-D)
  • Modèle / numéro de série
    Sanitary DNM Registration Number: IM072716042015
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    NDAESDNM