Events

Alerte De Sécurité sur Subcutaneous Implantable Defibrillator System

Selon National Institute of Drugs and Food Surveillance (INVIMA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Colombia qui a été fabriqué par Boston Scientific Corporation || Cardiac Pacemakers Incorporated.

Qu'est-ce que c'est?

Les alertes fournissent des informations importantes et des recommandations concernant les dispositifs médicaux. Le fait qu'une alerte soit émise ne signifie pas nécessairement qu'un dispositif soit dangereux. Les alertes de sécurité, qui sont envoyées tant aux travailleurs du secteur médical qu'aux utilisateurs de ces dispositifs, peuvent inclure des rappels. Elles peuvent être rédigées par des fabricants mais aussi par des autorités en charge de la santé.

En savoir plus sur les données ici
  • Type d'événement
    Safety alert
  • ID de l'événement
    A1707-295
  • Numéro de l'événement
    2014DM-0011699
  • Date
    2017-07-14
  • Pays de l'événement
    Colombia
  • Source de l'événement
    INVIMA
  • URL de la source de l'événement
    https://app.invima.gov.co/alertas/dispositivos-medicos-invima?page=79
  • Notes / Alertes
    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.
  • Notes supplémentaires dans les données
  • Cause
    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
  • Modèle / numéro de série
  • Description du dispositif
    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
  • Société-mère du fabricant (2017)
    Boston Scientific
  • Commentaire du fabricant
    “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