Events

Recall Or Safety Alert for Implantable cardiac defibrillators (ICDs) and defibrillators with cardiac resynchronization therapy (CRT-Ds) Platinium, models DF4: VR 1240, DR 1540, CRT-D 1741, SonR CRT-D1841, 4LV CRT-D 1744, 4LV SonR CRT-D 1844

According to Agencia Española de Medicamentos y Productos Sanitarios (Via FOI), this recall or safety alert involved a device in Spain 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
    Recall / Safety Alert
  • Date
    2018-03-22
  • Event Country
    Spain
  • Event Source
    AEMPSVFOI
  • Event Source URL
    N/A
  • Notes / Alerts
    The data from Spain is current through June 2018. All of the data comes from Agencia Española de Medicamentos y Productos Sanitarios, 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 Spain.
  • Extra notes in the data
  • Action
    Withdrawal from the market of certain models and serial numbers of DAIs and CRT-Ds Platinium models DF4, due to the possibility of intermittent contact loss of the DF4 connectors, which could cause the patient not to receive the necessary therapy. Follow-up of implanted patients according to what is indicated in the instructions for use, one month after discharge, and then every three months until the replacement date approaches. RECOMMENDATIONS The AEMPS, consulted by the Spanish Society of Cardiology (SEC), considers that the general recommendations of the company are adequate for the follow-up of implanted patients, emphasizing the importance of patients being included in the remote monitoring program through of the SMARTVIEW system.

Device

Implantable cardiac defibrillators (ICDs) and defibrillators with cardiac resynchronization thera...
  • Model / Serial
  • Manufacturer
    N/A

Manufacturer

N/A
  • Source
    AEMPSVFOI