Events

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

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
    49926
  • Clase de Riesgo del Evento
    II
  • Fecha de inicio del evento
    2016-10-28
  • 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 an increased number of complaints from customers involving reports of rechargers that are in an unresponsive error state where the recharger is non-functional with a blank display screen and is beeping every 5 seconds. when this error state occurs the recharger is unable to recharge the neurostimulator until the recharger is reset. if the neurostimulator battery is allowed to become fully depleted this can lead to loss of therapy and return of associated diseasespecific symptoms. if the implanted neurostimulator battery is allowed to remain fully depleted it may overdischarge resulting in a permanent reduction in battery capacity and the need to recharge more frequently in the future. model 37751 ins rechargers that are used by patients to recharge their ins devices. notification will be provided to active implanting and managing physicians of both scs and dbs therapies. all model 37751 rechargers that are included in model 37651 37754 and 97754 kits may be affected by this issue. for a subset of patients receiving dbs therapy in rare instances a loss of dbs therapy may result in a life threatening injury or death. for example patients being treated for parkinson's disease may experience akinetic crisis and patients treated for epilepsy may experience status epilepticus. medtronic has not received any reports of life threatening injury or death associated with this issue.

Device

RESTORESENSOR MULTI-PROGRAM RECHARGEABLE NEUROSTIMULATOR-CHARGING SYSTEM
  • Modelo / Serial
    Model Catalog: 37754 (Lot serial: All Lots); Model Catalog: 97754 (Lot serial: All Lots); Model Catalog: 37651 (Lot serial: All Lots)
  • Descripción del producto
    RESTORESENSOR MULTI-PROGRAM RECHARGEABLE NEUROSTIMULATOR-CHARGING SYSTEM;CHARGING SYSTEM;ACTIVA RC NEUROSTIMULATOR - IMPLANTABLE NEUROSTIMULATOR RECHARGER
  • 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