Events

Safety Alert for Implantable Automatic Defibrillators and Cardiac Resynchronization Therapy Defibrillators (CRT-D)

According to National Drugs Administration from El Salvador (DNM), this safety alert involved a device in El Salvador that was produced by N/A.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Event Risk Class
    Class I
  • Date
    2016-10-11
  • Event Country
    El Salvador
  • Event Source
    DNM
  • Event Source URL
    https://www.medicamentos.gob.sv/index.php/es/servicios-m/ciudadanos/alertas-dnm/alertas-sanitarias-internacionales
  • Notes / Alerts
    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.
  • Extra notes in the data
  • Reason
    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)
  • Model / Serial
    Sanitary DNM Registration Number: IM072716042015
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    NDAESDNM