Events

Retiro De Equipo (Recall) de EXTERNAL TEMPORARY PACEMAKER

Según Health Canada (via FOI), este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en Canada que fue producido por MEDTRONIC OF CANADA 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
    76401
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2014-04-28
  • País del evento
    Canada
  • Fuente del evento
    HC
  • Notas / Alertas
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 Canada.
  • Notas adicionales en la data
  • Causa
    Medtronic has identified a performance issue potentially affecting older model 5348 single-chamber external pulse generators (epgs) manufactured between july 1995 and december 2007. malfunction indications: due to the unpredictable nature of the oxidation process on multiple electrical contacts this issue may result in one or more of the following observations: o pacing rate outside of the intended setting potentially including a sudden increase in pacing rate up to the maximum setting of 180 ppm. o output amplitude or sensitivity outside of intended setting. o pace sense or low battery led indicators not lighting during power on or reset functions. o rapid atrial pacing (rap) display with intermittent functionality. o intermittent functionality of the on/off and rap control buttons.

Device

EXTERNAL TEMPORARY PACEMAKER
  • Modelo / Serial
    Model Catalog: 5348 (Lot serial: > 10 lot numbers contact mfg)
  • Descripción del producto
    Single-Chamber External Pulse Generator - EXTERNAL TEMPORARY PACEMAKER
  • Manufacturer
    MEDTRONIC OF CANADA LTD.

Manufacturer

MEDTRONIC OF CANADA LTD.
  • Dirección del fabricante
    BRAMPTON
  • 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
    HC