Events

Safety Alert for Defibrillator - Implantable Cardioverter ATLAS II AND EPIC II

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by St. Jude Medical Ab || St Jude Medical || St. Jude Medical Operations Sdn Bhd || St. Jude Medical. Cardiac Rhythm Management Division.

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
    A1604-158
  • Event Number
    2008DM-0001674
  • Date
    2017-04-06
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=94
  • 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 through routine electrical tests has identified faults originating in the manufacturing process, by assembling slightly larger vibrators that could damage the insulation coating of the high voltage capacitor, which would cause a narrowing of the distance between the two adjacent components, resulting in possible leakage of electrical current or an electric arc between the high-voltage capacitor and these components, leading to the occurrence of potential adverse events on patients.

Device

Defibrillator - Implantable Cardioverter ATLAS II AND EPIC II
  • Model / Serial
    CD1377-36C, CD1377-36QC, CD2377-36C and CD2377-36QC
  • Product Description
    Designed to administer ventricular antitachycardia and ventricular defibrillation for the automatic treatment of ventricular arrhythmias that endanger the life of the patient. Addition of indication: indication for magnetic resonance imaging, for MRI cardioid defibrillators models CD2377-36Q, CD2377-36QC, CD1377-36Q, CD1377-36QC and QUADRAASSURA cardioid defibrillators models CD3367-40QC, CD3367-40Q and QUADRAASSURA MP models CD3371-40QC, CD3371- 40Q. The cardiofibrillators FORTIFY ASSURA DR models CD2359-40Q, CD2359- CD2359-40QC, and FORTIFY ASSURAVR models CD1359-40Q, CD1359-40QC; they are conditional to magnetic resonance, the use of these devices conditionally safe in the MRI environment if a conditional DAI system is used to complete MRI.
  • Manufacturer
    St. Jude Medical Ab || St Jude Medical || St. Jude Medical Operations Sdn Bhd || St. Jude Medical. Cardiac Rhythm Management Division

Manufacturer

St. Jude Medical Ab || St Jude Medical || St. Jude Medical Operations Sdn Bhd || St. Jude Medical...
  • Manufacturer Parent Company (2017)
    Abbott Laboratories
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    NIDFSINVIMA