Events

Alerte De Sécurité sur 5392 Dual-Chamber External Pulse Generator

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

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
    2015-03-16
  • Date de publication de l'événement
    2015-03-17
  • 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_20150316b.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: medtronic model 5392 dual-chamber external pulse generator medical device manufacturer, medtronic, has issued a medical device safety alert concerning model 5392 dual-chamber external pulse generator (epg) [serial number equal or lower than djh009999p]. the manufacturer has received reports that the negative terminal of a commercially available aa (lr6) battery did not maintain sufficient connection with the battery drawer electrical contact. this could prevent the epg from powering on or cause the epg to abruptly lose primary battery power, potentially stopping delivery of pacing therapy. the manufacturer advises users to use aa (lr6) batteries where the negative terminal does not have an indentation and has also introduced a new battery drawer contact that is compatible with all aa (lr6) batteries. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 march 2015.

Device

5392 Dual-Chamber External Pulse Generator
  • Modèle / numéro de série
  • Description du dispositif
    Medical Device Safety Alert: Medtronic Model 5392 Dual-Chamber External Pulse Generator
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • Société-mère du fabricant (2017)
    Medtronic plc
  • Commentaire du fabricant
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DH