Events

Rappel de Device Recall Boston Scientific COGNIS

Selon U.S. Food and Drug Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à United States qui a été fabriqué par Boston Scientific CRM Corp.

Qu'est-ce que c'est?

Une correction ou un retrait opéré par un fabricant afin de répondre à un problème causé par un dispositif médical. Les rappels surviennent lorsqu'un dispositif médical est défectueux, lorsqu'il pourrait poser un risque pour la santé, ou les deux à la fois.

En savoir plus sur les données ici
  • Type d'événement
    Recall
  • ID de l'événement
    53994
  • Classe de risque de l'événement
    Class 2
  • Numéro de l'événement
    Z-0609-2010
  • Date de mise en oeuvre de l'événement
    2009-12-01
  • Date de publication de l'événement
    2010-01-13
  • Statut de l'événement
    Terminated
  • Pays de l'événement
    United States
  • Date de fin de l'événement
    2012-11-06
  • Source de l'événement
    USFDA
  • URL de la source de l'événement
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=86999
  • Notes / Alertes
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notes supplémentaires dans les données
    Implantable pulse generator, pacemaker (non-crt) - Product Code LWP
  • Cause
    Bsc crm provided important patient management information regarding boston scientific cognis crt-ds and teligen icds. engineering simulations and field reports indicate that in some cases, implanted devices may encounter sufficient mechanical stress to weaken the bond between the header and case when positioned subpectorally. a weakened header bond may alter lead impedance and introduce noise.
  • Action
    Boston Scientific CRM issued an "Urgent Medical Device Correction" letter dated December 01, 2009. The letter described the issue and potential device behavior. The letter provided recommendations to avoid issues relating to the affected device until improved devices become available. For further information, contact your local Boston Scientific CRM representative, United States Technical Services at 1-800-227-3422, or European Technical Services at +32-2-416-7222.

Device

Device Recall Boston Scientific COGNIS
  • Modèle / numéro de série
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    3
  • Dispositif implanté ?
    Yes
  • Distribution
    Worldwide Distribution -- United States including Guam, Puerto Rico, and U.S. - Virgin Islands. OUS to include: Argentina, Aruba, Australia, Austria, Bahamas, Barbados, Belgium, Bermuda, Brazil, Canada, Cayman Islands, Chile, China, Cocos (Keeling) Islands, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Ecuador, Egypt, Finland, Gabon, Germany, Greece, Hong Kong, Hungary, India, Iran, Ireland, Israel, Jordan, Kuwait, Latvia, Lebanon, Luxembourg, Malaysia, Mexico, Netherlands, New Zealand, Norway, Panama, Philippines, Poland, Portugal, Qatar, Russia, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Thailand, Trinidad & Tobago, Tunisia, United Arab Emirates, United Kingdom and Venezuela.
  • Description du dispositif
    Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. the following models are not available in the US: models N106, N107, P106, P107, P108. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. || Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support.
  • Manufacturer
    Boston Scientific CRM Corp

Manufacturer

Boston Scientific CRM Corp
  • Adresse du fabricant
    Boston Scientific CRM Corp, 4100 Hamline Ave N, Saint Paul MN 55112-5700
  • Source
    USFDA