Events

Retiro De Equipo (Recall) de Device Recall Medtronic Sutureless Pump Connector Revision Kit

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
    65342
  • Clase de Riesgo del Evento
    Class 1
  • Número del evento
    Z-1573-2013
  • Fecha de inicio del evento
    2013-06-03
  • Fecha de publicación del evento
    2013-06-24
  • Estado del evento
    Terminated
  • País del evento
    United States
  • Fecha de finalización del evento
    2014-04-07
  • Fuente del evento
    USFDA
  • URL de la fuente del evento
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118593
  • 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
    Pump, infusion, implanted, programmable - Product Code LKK
  • Causa
    The sutureless connector (sc) intrathecal catheter connector has been redesigned to reduce the potential for occlusion at the catheter to pump interface. medtronic is removing the unused products from the market that were manufactured with the previous design, and recommend the previous design no longer be used due to greater potential for misalignment and subsequent occlusion.
  • Acción
    The firm, Medtronic, sent an "Urgent: Medical Device Removal" letter dated May 2013 to its customers. The letter described the product, problem and actions to be taken. Representatives (Rep) are visiting all locations, beginning June 3, 2013, to retrieve devices with a Use By date of 2014 08 14 (August 14, 2014) or sooner. The Rep is leaving a letter with the hospitals to tell them that the Sutureless Connector Intrathecal Catheter connector has been redesigned and that they are removing unused devices. They also do not recommend using any of the old design. An Account Specific Customer Confirmation Form will be completed by the Rep. A copy of the completed form will be left with the Hospital along with the Urgent Medical Device Removal letter. If you have questions, please contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7am - 6pm CST.

Device

Device Recall Medtronic Sutureless Pump Connector Revision Kit
  • Modelo / Serial
    Product having a Use By Date prior to 25 Aug 2014
  • Clasificación del producto
    General Hospital and Personal Use Devices
  • Clase de dispositivo
    3
  • ¿Implante?
    Yes
  • Distribución
    Worldwide distribution: US (nationwide) and countries of: Aruba, Australia, Austria, Belgium, Canada, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Georgia, Germany, Greece, Guadeloupe, Hong Kong, Hungary, Iceland, India, Ireland, Israel, Italy, Jordan, Korea, Kuwait, Lebanon, Lithuania, Luxembourg, Malta, Martinique, Morocco, Netherlands, Netherlands Antilles, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Qatar, Romania, Russian Federation, San Marino, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Thailand, Trinidad and Tobago, Turkey, United Arab Emirates, United Kingdom, Uruguay, and Venezuela.
  • Descripción del producto
    Medtronic Sutureless Pump Connector Revision Kit, model 8578. Contents: catheter interface with attached sutureless pump connector, catheter, connector pin, and strain-relief sleeve to be used with Medtronic SynchroMed implantable drug infusion pumps. Contents of inner package are STERILE. || The Medtronic Model 8578 Sutureless Pump Connector Revision Kit is used when a pump connector for an Indura 1P Model 8709 or Model 8709SC catheter is required. The catheter is part of an infusion system that stores and delivers parenteral drugs to the intrathecal space. The implanted infusion system components consist of a Medtronic pump and an Indura 1P Model 8709 or Model 8709SC catheter. The catheter connects to the pump with the Model 8578 sutureless pump connector at the catheter port.
  • 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