Events

Retiro De Equipo (Recall) de Medtronic DBS Extension Kit for

Según U.S. Food and Drug Administration, este evento ( retiro de equipo (recall) ) involucró a un dispositivo médico en United States que fue producido por Medtronic Neuromodulation.

¿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
    71016
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
    Z-1617-2015
  • Fecha de inicio del evento
    2015-04-16
  • Fecha de publicación del evento
    2015-05-15
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2016-07-22
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135848
  • Notas / Alertas
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Notas adicionales en la data
    Stimulator, electrical, implanted, for parkinsonian tremor - Product Code MHY
  • Causa
    Medtronic is providing important information regarding extension handling during implant procedure after receiving reports of high impedances. this applies to extension models 37085 and 37086 which can be used with the following implantable neurostimulators: activa¿ pc (model 37601), activa¿ rc (model 37612), and the activa¿ sc (model 37603).
  • Acción
    Medtronic began notifying consignees with an Urgent Medical Device Safety Notification letter beginning April 16, 2015. Consignees will be notified by mail and/or in person, by visit of a Medtronic field representative. The letter described the issue and provided recommendations of following the instructions defined within the Neurostimulator implant manual. A Physician Reply Form was asked to be returned via fax at 800-897-3899 or email to neuro.quality@medtronic.com. Consignees with questions can contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7am - 6pm CST.

Device

Medtronic DBS Extension Kit for
  • Modelo / Serial
    all Serial numbers
  • Clasificación del producto
    Neurological Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    worldwide
  • Descripción del producto
    Medtronic DBS Extension Kit for Deep Brain Stimulation, Models 37085 and 37086. Sterile
  • Manufacturer
    Medtronic Neuromodulation

Manufacturer

Medtronic Neuromodulation
  • Dirección del fabricante
    Medtronic Neuromodulation, 7000 Central Ave Ne, Minneapolis MN 55432-3568
  • 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
    USFDA