Events

Retiro De Equipo (Recall) de Model 3200 programmer for Emblem, Emblem MRI and SQ-Rx Subcutaneous-Implantable Cardiac Defibrillators (S-ICDs)

Según Department of Health, Therapeutic Goods Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Australia que fue producido por Boston Scientific 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-2017-RN-00077-1
  • Clase de Riesgo del Evento
    Class I
  • Fecha de inicio del evento
    2017-01-19
  • 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-2017-RN-00077-1
  • 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 potential for radio frequency (rf) interference to alter wireless communication from the model 3200 programmer, which in rare instances may cause an s-icd to perform an unintended command, such as the unintended initiation of pg-based tachyarrhythmia induction of a patient, or a command that results in therapy being unavailable after the telemetry session has ended, both of which could result in patient death. this behaviour can only occur during an active, in-clinic interrogation/programming session with the model 3200 s-icd programmer. there is no risk of this behaviour occurring when the latitude patient management system communicates with an s-icd in an ambulatory setting. to date, a total of ten observations of unintended programming commands or data changes have been observed, with no instances of permanent injury or death.
  • Acción
    Boston Scientific is developing software to mitigate this issue. Until updated software is available, recommendations that mitigate the risks associated with this issue, and which are detailed in the customer letter, are to be followed.

Device

Model 3200 programmer for Emblem, Emblem MRI and SQ-Rx Subcutaneous-Implantable Cardiac Defibrill...

Manufacturer

Boston Scientific Pty Ltd
  • Empresa matriz del fabricante (2017)
    Boston Scientific
  • Comentario del fabricante
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DHTGA