Events

Alerte De Sécurité sur SonRtip endocardial pacing lead with contractility sensor, model PS55D

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

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
    2012-02-28
  • 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_20120228b.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
    Field safety notice: sonrtip endocardial pacing lead with contractility sensor, model ps55d the medicines and healthcare products regulatory agencies (mhra), united kingdom posted a field safety notice concerning sonrtip endocardial pacing lead with contractility sensor, model ps55d. the manufacturer of the device, sorin crm, has received two reports in post-market surveillance that part or all of the fixation helix of the sonrtip lead remained in the myocardium after the lead had been removed. no permanent injury or death has occurred. investigation by the manufacturer revealed that an excessive number of turns has been applied to the lead during fixation. according to the local supplier, the affected product is not distributed in hong kong. for details, please refer to the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/index.Htm if you are in possession of the product, please contact your supplier for necessary actions.

Device

SonRtip endocardial pacing lead with contractility sensor, model PS55D
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: SonRtip endocardial pacing lead with contractility sensor, model PS55D
  • Manufacturer
    Sorin CRM

Manufacturer

Sorin CRM