Retiro De Equipo (Recall) de RESTORESENSOR MULTI-PROGRAM RECHARGEABLE NEUROSTIMULATOR

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
    62579
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-04-27
  • País del evento
  • 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 confirmed several instances of recharging sessions of a restoresensor implantable neurostimulator (ins) that ended without achieving a sufficient recharge to maintain stimulation therapy. this may cause the neurostimulator to enter into a rapid battery depletion state due to an error in the device causing the device battery level to decrease to the over discharged state within a couple days versus the 30 day decrease to the over discharged state in normal operation. when the neurostimulator battery is allowed to over discharge therapy is unavailable and the patient cannot charge the neurostimulator however battery function may be restored using the physician recharge mode of the recharger. as noted in the current labeling if three occurrences of over discharge occur the neurostimulator will no longer function and must be replaced.

Device

  • Modelo / Serial
    Model Catalog: 37714 (Lot serial: All lots); Model Catalog: 97714 (Lot serial: All lots)
  • Descripción del producto
    RESTORESENSOR MULTI-PROGRAM RECHARGEABLE NEUROSTIMULATOR;RESTORESENSOR SURESCAN MRI NEUROSTIMULATOR
  • Manufacturer

Manufacturer

  • Dirección del fabricante
    BRAMPTON
  • 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
    HC