Events

Rappel de InSync III Cardiac Resynchronisation Therapy Pacemakers (CRT-P)

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-2015-RN-01108-1
  • Classe de risque de l'événement
    Class I
  • Date de mise en oeuvre de l'événement
    2015-11-13
  • 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-2015-RN-01108-1
  • 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
    There is an issue with insync iii crt-ps related to long-term battery performance because of unexpected high battery impedance. unexpected high battery impedance can result in the battery’s inability to supply sufficient electrical current, impacting device function. if pacing capture is compromised, some patients may experience a return of heart failure symptoms due to loss of biventricular pacing. in cases involving pacemaker-dependent patients, a loss of pacing capture could result in serious injury or death. insync iii crt-pacemakers are no longer distributed. current devices have a modified battery design that is not susceptible to this issue.Through 27 october 2015, the events have occurred in devices with implant durations of 53 months or more. medtronic's modelling predicts an estimated failure rate between 0.16% and 0.6%. there is no provocative testing that can predict which specific devices may fail, and there is no programming that can mitigate this issue.
  • Action
    Medtronic is issuing following recommendations to cardiologists and surgeons for managing patients with an InSync III CRT-pacemaker: - Prophylactic device replacement in non-pacemaker-dependent patients is not recommended. - For pacemaker-dependent patients, physicians should carefully weigh the risks and benefits of device replacement to mitigate this issue on an individual patient basis. The estimated per patient mortality risk of this issue (0.007% to 0.02%) is comparable to the estimated per patient mortality risk of complications associated with an incremental, early device replacement (0.005%). - Continue routine patient follow up in accordance with standard practice, and advise patients to seek medical attention immediately if they experience new or unexpected symptoms. Medtronic is also including a draft patient letter for cardiologists and surgeons to contact their patient about this matter. Also, Medtronic is offering a supplemental device warranty. For further information please see https://www.tga.gov.au/alert/insync-iii-cardiac-resynchronisation-therapy-pacemakers . This action has been closed-out on 20/04/2017.

Device

InSync III Cardiac Resynchronisation Therapy Pacemakers (CRT-P)

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