Events

Rappel de EnTrust VR/DR/AT ICDs

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-2018-RN-00833-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2018-07-02
  • 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-2018-RN-00833-1
  • 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 has identified the potential for loss of high voltage and anti-tachycardia pacing therapy in entrust implantable cardioverter defibrillators (icds) as they near elective replacement indicator (eri) voltage. affected devices may display an immediate “end of life” (eol) observation with no prior alert (implanted electronic heart devices are designed to alert physicians and patients as the device battery depletes). though no elective replacement indicator (eri) alert is triggered, there may not be enough remaining battery capacity to charge the high voltage circuits, resulting in an excessive charge time eol observation. bradycardia (pacing) therapies will continue to operate as expected. medtronic has received no reports of patient deaths or serious adverse events due to this issue.
  • Action
    Medtronic is advising the below for surgeons following consultation with the Independent Physician Quality Panel: - Schedule an in-office patient follow-up as soon as possible to assess the potential for this issue per the steps outlined in the Customer Letter. - Ensure the Excessive Charge Time EOL…and the Low Battery Voltage ERI… Patient Alerts have been programmed to “On-High”. - Instruct patients to contact your office if they hear device alert tones. Consider utilising the “Demonstrate Tones. . .” function to ensure patients recognise the audible tone. - If this issue has occurred, an “EOL: replace device immediately” Observation will be displayed on the QuickLook report. Schedule device replacement immediately. The Customer Letter provides information for surgeons to ensure high voltage therapy remains as the device battery voltage approaches its 2.61V ERI threshold.

Device

EnTrust VR/DR/AT ICDs

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