Events

Alerte De Sécurité sur INLIVEN Cardiac Resynchronization Therapy Pacemakers

Selon Department of Health, ce/cet/cette alerte de sécurité concerne un dispositif en/au/aux/à Hong Kong qui a été fabriqué par Boston Scientific.

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
  • Date
    2015-09-23
  • Date de publication de l'événement
    2015-09-23
  • Pays de l'événement
    Hong Kong
  • Source de l'événement
    DH
  • URL de la source de l'événement
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150923a.html
  • Notes / Alertes
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 Hong Kong.
  • Notes supplémentaires dans les données
    Medical Device Safety Alert
  • Cause
    Medical device safety alert: boston scientific inliven cardiac resynchronization therapy pacemakers medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its inliven cardiac resynchronization therapy pacemakers (crt-ps) [model w275]. according to the manufacturer, fifty-five (55) model w275 inliventm cardiac resynchronization therapy pacemakers (crt-ps) distributed by boston scientific in france and the czech republic are affected. label diagrams on the outer box and inner tray packaging of affected devices incorrectly describe the location of the lead ports on the device header. the correct lead port locations are etched on the case of the pacemaker and are visible at implant. the physician technical manual is also correct. if a pacing lead were to be inserted into the incorrect header port, inappropriate pacing could lead to loss of av or rv/lv synchrony, possibly with worsening heart failure until corrected. inappropriate pacing can be detected through standard device testing by evaluating either the intracardiac or surface electrocardiograms (ecg). the manufacturer advises affected users to take the following actions:- ensure that pacing leads are inserted into the correct lead ports. verify that all pacing leads are connected to the correct ports, either by reviewing device operation on intracardiac or ecg strips in medical records from a previous visit or by patient follow-up. according to the local supplier, the affected batch of products is not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 23 september 2015.

Device

INLIVEN Cardiac Resynchronization Therapy Pacemakers
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Boston Scientific INLIVEN Cardiac Resynchronization Therapy Pacemakers
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • 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
    DH