Events

Rappel de NANOSTIM LEADLESS PACEMAKER NANOSTIM DELIVERY SYSTEM CATHETER

Selon Health Canada (via FOI), ce/cet/cette rappel concerne un dispositif en/au/aux/à Canada qui a été fabriqué par ABBOTT MEDICAL CANADA INC..

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
    24963
  • Classe de risque de l'événement
    II
  • Date de mise en oeuvre de l'événement
    2017-11-17
  • Pays de l'événement
    Canada
  • Source de l'événement
    HC
  • Notes / Alertes
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notes supplémentaires dans les données
  • Cause
    As part of abbott's post market surveillance and clinical trial monitoring processes we have been made aware of docking button detachments that have occurred following implant or during attempted retrieval of nanostim leadless cardiac pacemaker (lcp) devices model number s1dlcp. in all three cases that have occurred there has been no impact to the electrical function (e.G. pacing sensing communication) and no clinical impact or symptoms resulting from the docking button detachment or exposed cables.

Device

NANOSTIM LEADLESS PACEMAKER NANOSTIM DELIVERY SYSTEM CATHETER
  • Modèle / numéro de série
    Model Catalog: S1DLCP (Lot serial: N/A)
  • Description du dispositif
    NANOSTIM LEADLESS CARDIAC PACEMAKER
  • Manufacturer
    ABBOTT MEDICAL CANADA INC.

Manufacturer

ABBOTT MEDICAL CANADA INC.
  • Adresse du fabricant
    MISSISSAUGA
  • Société-mère du fabricant (2017)
    Abbott Laboratories
  • Commentaire du fabricant
    “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
    HC