Events

Rappel de Medtronic MyCareLink Remote Monitors

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-2017-RN-01009-1
  • Classe de risque de l'événement
    Class II
  • Date de mise en oeuvre de l'événement
    2017-08-10
  • 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-2017-RN-01009-1
  • 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
    Medtronic is updating the instructions for use (ifu) for medtronic mycarelink remote monitors related to patients monitored on the medtronic carelink network with two (2) or more implanted medtronic heart devices. if a patient has multiple devices, there are potential impacts on the ability to remotely monitor that patient’s heart devices. these potential impacts could lead to missed carealert notifications or device reports. medtronic does not recommend the use of remote monitoring for patients with multiple implanted medtronic heart devices and clinicians should take this into account when implanting an additional medtronic heart device or preparing a patient for remote monitoring. for example, if a medtronic pacemaker is implanted in a patient with an existing reveal linqtm insertable cardiac monitor (icm), it may not be possible to monitor either device remotely.
  • Action
    Medtronic does not recommend the use of remote monitoring for patients with multiple implanted Medtronic heart devices and clinicians should take this into account when implanting an additional Medtronic heart device1 or preparing a patient for remote monitoring.

Device

Medtronic MyCareLink Remote Monitors
  • Modèle / numéro de série
    Medtronic MyCareLink Remote Monitors Models: 24950, 25000ARTG Numbers: 215442, 283843 and 235570
  • 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