Events

Retiro De Equipo (Recall) de Model 5348 Single-Chamber External Pulse Generator

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-2014-RN-00495-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2014-05-08
  • 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-2014-RN-00495-1
  • 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
    Medtronic has identified the development of high resistance on internal electrical connector contacts due to oxidation over time. due to the unpredictable nature of the oxidation process on multiple electrical contacts, this issue may result in one or more of the following: • pacing rate outside of the intended setting, potentially including a sudden increase in pacing rate up to the maximum setting of 180 ppm. • output amplitude or sensitivity outside of intended setting. • pace, sense, or low battery led indicators not lighting during power on or reset functions. • rapid atrial pacing (rap) display with intermittent functionality. • intermittent functionality of the on/off and rap control buttons.
  • Acción
    Medtronic recommends that the following actions be taken when using a potentially affected Model 5348 EPG: • Monitor the EPG function and patient’s heart rhythm continuously while the EPG is in use to ensure it is operating properly and delivering appropriate therapy to the patient. • If any malfunction is observed with a 5348 EPG, ensure the patient’s condition is stabilized, discontinue use of the Model 5348 device and contact your Medtronic representative. During the design and development of new models, Medtronic identified that a service life of five years is most appropriate for an External Pulse Generator. Therfore, Medtronic is advising customers that they will no longer provide standard servicing of EPGs (calibration, physical inspection or repair) that are more than five years old including these potentially affected 5348 EPGs. Continued use of the device will require end users to perform the relevant maintenance procedures to ensure safe and effective operation of the devices.

Device

Model 5348 Single-Chamber External Pulse Generator

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