Alerte De Sécurité sur Implantable Resynchronizing Defibrillator COGNIS 100 - Model: N119 - Register: 10341350536 - Risk Class IV (SERIES AFFECTED IN ANNEX)

Selon Agência Nacional de Vigilância Sanitária (ANVISA), ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Brazil qui a été fabriqué par Boston Scientific do Brasil Ltda; Boston Scientific Clonmel Limited.

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
  • Date
  • Pays de l'événement
  • Source de l'événement
  • URL de la source de l'événement
  • Notes / Alertes
    Brazilian data is current through June 2018. All of the data comes from Anvisa, 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 data from the U.S. and Brazil.
  • Notes supplémentaires dans les données
    Company informs that an online search tool is available at to determine if a particular serial / model combination is within the subset identified for public search. (LETTER TO THE PATIENT IN ANNEX)
  • Cause
    In august 2013, boston scientific reported a field action reporting that the performance of a low voltage capacitor in this subset of devices could be compromised over time, causing increased drain current, which could lead to premature battery depletion for products in relation to the subset of cognis® crt-ds and teligen® icds, manufactured before december 2009. on september 11, 2014, boston scientific identified a few more batches that may be compromised by this same situation. boston scientific has deployed and deployed a total of approximately 267,000 cognis and teligen defibrillators since may 2008. however, a subset of ~ 50,100 devices that were manufactured prior to december 2009 have shown a greater number of failures in lv capacitors (approximately 0.08% or 1 in 125). devices in this subset have not been available for implantation since november 2010. in contrast to the subset population, the lv capacitor performance decrease rate of other cognis / teligen devices (225,500) is approximately 0.0093% or 1 in 10,700. (letter to the doctor in annex).
  • Action
    For this subset of devices, Boston Scientific recommends regular monitoring of the device as indicated on the label. You also recommend that the customer contact the Technical Services when investigating a Security Architecture alert. After the Safety Architecture or Explosion Indicator alert due to the decrease in the performance of the low voltage capacitor, the normal replacement window of three months can be reduced and the increased drain current can deplete the battery and compromise therapy / telemetry. The Technical Services sector can help estimate the availability time for device replacement if a low voltage alert or Explante indicator occurs. CRM Code 001-2014


  • Société-mère du fabricant (2017)
  • 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