Events

Retiro De Equipo (Recall) de Device Recall Medtronic Intrathecal Catheter

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
    48761
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-2381-2008
  • Fecha de inicio del evento
    2008-06-26
  • Fecha de publicación del evento
    2008-09-25
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2011-06-06
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=72071
  • 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
    Intrathecal Catheter - Product Code LKK
  • Causa
    Disconnection of the medtronic sutureless connector (sc) catheters from the catheter port on the pump, or occlusion between the sutureless pump connector and the catheter port on the pump.
  • Acción
    Medtronic sent A Safety Alert dated June 2008, on June 27, 2008, to healthcare professionals, which described the issues of occlusion and disconnect. The letter identifies the affected catheter and revision kit model numbers and the associated implantable infusion pumps. The issues do not involve Medtronic MiniMed insulin pump. The letter refers the HCP to recommendations for Implant Techniques and Recommendations for Patency Verification that are included with the letter. The letter also includes recommendations for managing patients with implanted SC catheters.

Device

Device Recall Medtronic Intrathecal Catheter
  • Modelo / Serial
    All SC Catheters
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide Distribution: USA, Puerto Rico, Algeria, Aruba, Austria, Australia, Belgium, Canada, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, French Polynesia, Germany, Greece, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jordan, Kuwait, Lebanon, Luxembourg, Malta, Netherlands, Netherlands Antilles, Norway, Poland, Portugal, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Turkey, United Arab Emirates, and United Kingdom.
  • Descripción del producto
    Medtronic Intrathecal Catheter, model 8731SC. 38.1 cm spinal segment with length markers and guide wire, 66 cm pump segment, separate connector pin, 15T gauge introducer needles (2) (11.4 cm and 9.3 cm), Transparent strain-relief sleeves (2), Opaque Strain-relief sleeves (2), V-wing Anchors (2).
  • Manufacturer
    Medtronic Neuromodulation

Manufacturer

Medtronic Neuromodulation
  • Dirección del fabricante
    Medtronic Neuromodulation, 800 53rd Ave NE, PO Box 1250, Minneapolis MN 55440-1250
  • Source
    USFDA