Events

Retiro De Equipo (Recall) de SYMPLICITY RENAL DENERVATION CATHETER

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
    17440
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2013-01-24
  • 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 an issue with the symplicity model rdn006 catheter cable connectors which may prevent therapy delivery. the symptoms include: o a flickering generator display screen upon initial catheter connection o generator status display of "check connection" o rapid fluctuations in the temperature reading o multiple early termination of energy delivery accompanied by "check status" safety codes 22 23 and/or 32 despite confirming electrode placement as defined by the ifu. this issue is isolated to the catheter and does not impact the rf generator. medtronic is distributing this notification to inform of methods to detect the failure and guidance to minimize inconveniences.

Device

SYMPLICITY RENAL DENERVATION CATHETER
  • Modelo / Serial
    Model Catalog: RDN006 (Lot serial: > 10 lot numbers contact mfg)
  • Descripción del producto
    SYMPLICITY RENAL DENERVATION CATHETER
  • 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