Events

Safety Alert for Intracranial Monitoring System

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Integra Lifesciences Corporation || Integra Neurosciences Ltd. || Integra Neurosciences || Integra Lifesciences Limited (Ireland).

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 ID
    I1505-192
  • Event Number
    2010DM-0006272
  • Date
    2015-05-12
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=180
  • Notes / Alerts
    Colombian data is current through June 2019. All of the data comes from the National Institute of Drugs and Food Surveillance (INVIMA), 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 Colombia.
  • Extra notes in the data
  • Reason
    The manufacturer states that there is a possibility of failures in the system of sound alarms due to the malfunctioning of the speaker, leading to the occurrence of possible adverse events on the patients.

Device

Intracranial Monitoring System
  • Model / Serial
    Licox and Camino, reference CAM02 and LCX02 / LCX02R
  • Product Description
    The integrated intracranial neuromonitoring system is indicated to measure and record pressure, temperature and / or intracranial oxygen of patients that require this type of monitoring in the parenchyma or in the subacranial space for administration of severe cerebral lesions and in case of cerebral hypertension and in extracranial medical conditions such as failurehepatic or cardiac bypass surgery. The transducer catheter of the system is indicated to obtain the depression, temperature or o2 measurement inside directly from the inside of the patient's skull or through a cerebrospinal fluid adrenaje connector and is designed to be specifically connected to the intracranial monitor through the preamplification cable of the system. The instruments of the system are specific and indispensable for the implantation or removal of the transducer catheter because they have been specifically designed for the system. The use of other instruments can jeopardize the integrity and performance of the system as well as the safety and life of the patient.
  • Manufacturer
    Integra Lifesciences Corporation || Integra Neurosciences Ltd. || Integra Neurosciences || Integra Lifesciences Limited (Ireland)

Manufacturer

Integra Lifesciences Corporation || Integra Neurosciences Ltd. || Integra Neurosciences || Integr...