Events

Safety Alert for Subcutaneous Implantable Defibrillator System

According to National Institute of Drugs and Food Surveillance (INVIMA), this safety alert involved a device in Colombia that was produced by Boston Scientific Corporation || Cardiac Pacemakers Incorporated.

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
    A1707-295
  • Event Number
    2014DM-0011699
  • Date
    2017-07-14
  • Event Country
    Colombia
  • Event Source
    INVIMA
  • Event Source URL
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=79
  • 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 reports that it has detected that the referenced s-icd has delivered an atypical amount of energy (similar to the arrhythmia induction function), because a location of the specific memory was damaged by radiation within the environment, this highly unlikely behavior avoids detection / treatment of the arrhythmia, leading to the occurrence of possible adverse events in patients.

Device

Subcutaneous Implantable Defibrillator System
  • Model / Serial
  • Product Description
    Administer defibrillation treatment for the treatment of life-threatening ventricular tachyarrhythmias in patients who do not present with symptomatic bradycardia, incessant ventricular tachycardia, or frequent recurrent spontaneous ventricular tachycardia that are safely determined with cardiac pacing contrataquicardias.
  • Manufacturer
    Boston Scientific Corporation || Cardiac Pacemakers Incorporated

Manufacturer

Boston Scientific Corporation || Cardiac Pacemakers Incorporated
  • Manufacturer Parent Company (2017)
    Boston Scientific
  • Manufacturer comment
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    NIDFSINVIMA