Retiro De Equipo (Recall) de Medtronic Amplia CRT-D Sure Scan

Según New Zealand Medicines and Medical Devices Safety Authority, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en New Zealand que fue producido por Medtronic Inc.

¿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
  • ID del evento
  • Fecha de inicio del evento
  • País del evento
  • Fuente del evento
  • URL de la fuente del evento
  • Notas / Alertas
    Data from New Zealand is current through July 2018. All of the data comes from the New Zealand Medicines and Medical Devices Safety Authority, 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 New Zealand.
  • Notas adicionales en la data
    Recalling Organisation: Medtronic New Zealand Limited, Unit 16 Mezzanine Level, 5 Gloucester Park Road, Onehunga, AUCKLAND
  • Causa
    Phase 1: manufacturer has identified a device software issue that may occur with all models of claria mri crt-d surescan and amplia mri crt-d surescan devices. the issue is a loss of lv pacing that occurs following a specific device programming sequence. as of november 10 , 2016, the manufacturer has observed an overall occurrence rate of 0.38%. but all tachyarrhythmia detection and therapy features remain fully operational. the software issue can be corrected by re-programming the device., the manufacturerwill also address an unrelated transient mode switch behaviour that may occur in mri quadripolar crt-d device models (claria mri™, amplia mri™ and compia mri™)., phase 2: a software update is being developed to address this issue and will be communicated to clinicians once it becomes available, the updated software (sw034 software version 8.2) is now available to correct the issue 1 in the affected claria mri and amplia mri crt-d surescan devices.
  • Acción
    Software to be upgraded


  • Modelo / Serial
    Model: DTM2D1, Affected:
  • Manufacturer


  • Empresa matriz del fabricante (2017)
  • 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