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
  • ID del evento
  • Clase de Riesgo del Evento
    Class 2
  • Número del evento
  • Fecha de inicio del evento
  • Fecha de publicación del evento
  • Estado del evento
  • País del evento
  • Fecha de finalización del evento
  • Fuente del evento
  • URL de la fuente del evento
  • 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
    This recall is related to the potential for reduced battery performance in a small percentage of medtronic model 8637 synchromed¿ ii pumps with batteries manufactured during two distinct time periods prior to april 2005. nature of the device issue: as part of ongoing analysis of returned explanted product, medtronic has confirmed that reduced battery performance resulted in eight (8) occurrence.
  • Acción
    Consignees were sent on July 7, 2009 a Medtronic " Urgent: Medical Device Correction" letter dated July 2009. The letter was addressed to Healthcare Professionals. The letter described the nature of the Device Issue, Scope, Potential Severity of the Issue, Recommendations, Ongoing patient Management Recommendations and Additional Information. Important patient management information is also available at under the heading Product Advisories. Direct questions to your Medtronic Field Representative or Medtronic Neuromodulation Technical Services by calling at 1-800-707-0933.


  • Modelo / Serial
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    US (including DC and Puerto Rico), Australia, India, canada, Hong Kong, Japan, Austria, Belgium Cyprus, Denmark, Egypt, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Poland, Portugal, San Marino, Saudi Arabi, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, Tunisia, Turkey, United Arab Emirates, United Kingdom and Vatican City.
  • Descripción del producto
    Medtronic SynchroMed¿ II Programmable Pump, 8637, Rx Only, Sterilized by ethylene oxide gas, Medtronic inc., Minneapolis, MN 55432-5604. (The SynchroMed¿ II Pump is supplied in 20 ml or 40 ml reservoir size.) || Affected products are SynchroMed II Model 8637 pumps with batteries (MECC Lifetest Batteries) manufactured from April 9, 2002 through July 2, 2002 (internally defined as Time Period 1), and from August 15, 2003 to March 16, 2005 (internally defined as Time Period 3). || The SvnchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the certain drugs and fluids.
  • Manufacturer


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