Events

Rappel de Medtronic Reveal LINQ Insertable Cardiac Monitor (ICM)

Selon Department of Health, Therapeutic Goods Administration, ce/cet/cette rappel concerne un dispositif en/au/aux/à Australia qui a été fabriqué par Medtronic Australasia Pty Ltd.

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
    RC-2016-RN-00644-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2016-06-07
  • Pays de l'événement
    Australia
  • Source de l'événement
    DHTGA
  • URL de la source de l'événement
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-00644-1
  • Notes / Alertes
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • Notes supplémentaires dans les données
  • Cause
    In february 2016, medtronic issued a medical device hazard alert communication that indicated medtronic reveal linq insertable cardiac monitors (icms) could experience a performance issue that affects the recommended replacement time (rrt) alert. this original communication named phase 1, also explained that medtronic was awaiting a software update to address this issue.Medtronic has now developed the necessary software and is ready to begin applying this update to all reveal linq icms which constitutes phase 2 of the alert.Once installed, this software update will reset rrt & end of service (eos) status and re-enable wireless transmissions for devices that have experienced premature rrt /eos. the update will also prevent the occurrence of premature rrt alerts due to this issue. refer to the original communication for additional details (rc-2016-rn-00202-1).
  • Action
    Medtronic will be providing a software update as a permanent correction. For more information, please see https://www.tga.gov.au/alert/medtronic-reveal-linq-insertable-cardiac-monitor. This action has been closed-out on 17/02/2017.

Device

Medtronic Reveal LINQ Insertable Cardiac Monitor (ICM)
  • Modèle / numéro de série
    Medtronic Reveal LINQ Insertable Cardiac Monitor (ICM) Model LNQ11 ARTG Number: 218791
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • 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
    DHTGA