Events

Retiro De Equipo (Recall) de InSync III Cardiac Resynchronisation Therapy Pacemakers (CRT-P)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Medtronic Australasia Pty Ltd.

¿Qué es esto?

Una corrección al equipo o acción de retiro tomada por el fabricante para abordar un problema con un dispositivo médico. Los retiros (recalls) ocurren cuando un dispositivo médico está defectuoso, cuando puede poner en riesgo la salud, o cuando simultáneamente está defectuoso y puede poner en riesgo la salud.

Más información acerca de la data acá
  • Tipo de evento
    Recall
  • ID del evento
    RC-2015-RN-01108-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2015-11-13
  • País del evento
    Australia
  • Fuente del evento
    DHTGA
  • URL de la fuente del evento
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2015-RN-01108-1
  • Notas / Alertas
    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.
  • Notas adicionales en la data
  • Causa
    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.
  • Acción
    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
  • Empresa matriz del fabricante (2017)
    Medtronic plc
  • Comentario del fabricante
    “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