• Modelo / Serial
    Model Catalog: 8627L (Lot serial: >100 NUMBERSCONTACT MANUFACT.); Model Catalog: 8626 (Lot serial: >100 NUMBERSCONTACT MANUFACT.); Model Catalog: 8626L10 (Lot serial: >100 NUMBERSCONTACT MANUFACT.); Model Catalog: 8627 (Lot serial: >100 NUMBERSCONTACT MANUFACT.); Model Catalog: 8637 (Lot serial: >100 NUMBERSCONTACT MANUFACT.); Model Catalog: 8472 (Lot serial: >10 NUMBERSCONTACT MANUFACT.)
  • Descripción del producto
  • Manufacturer
  • 1 Event


  • Dirección del fabricante
  • 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

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  • Modelo / Serial
  • Descripción del producto
  • Manufacturer
  • Modelo / Serial
    Model 8627-10, serial numbers: NGE000001 - NGE000242R .  Model 8627-18, serial numbers: NGF000001 - NGF003266R.  Model 8627L-10, serial numbers: NGG000001R - NGG000068R,  Model 8627L-18, serial numbers: NGH000001R - NGH001780R.
  • Clasificación del producto
  • Clase de dispositivo
  • ¿Implante?
  • Distribución
    Worldwide distribution ---- including USA, Argentina, Barbados, Canada, Germany, India, Ireland, Italy, Mexico, The Netherlands, Spain, Switzerland, and United Kingdom.
  • Descripción del producto
    Medtronic SynchroMed EL Programmable Pumps, Models 8627-10, 8627-18, 8627L-10, 8627L-18. The implantable Medtronic SynchroMed EL Programmable Pump is part of the SynchroMed EL Infusion System designed to contain and administer parenteral drugs to a specific site. The implantable components of the SynchroMed EL Infusion System include the pump with or without a side catheter access port, catheters, and catheter accessories.
  • Manufacturer
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