Viva Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and Evera Implantable Cardioverter Defibrillators (ICDs)

  • Modelo / Serial
    Product Name: Viva XT CRT-D Models: DTBA1D4, DTBA1D1 Product Name: Viva S CRT-D Models: DTBB1D4, DTBB1D1 Product Name: Evera XT DR ICD Models: DDBB1D4, DDBB1D1, DDBB2D4, DDBB2D1 Product Name: Evera S DR ICD Models: DDBC3D1, DDBC3D4 Product Name: Evera XT VR ICD Models: DVBB1D1, DVBB2D4 Serial Numbers: See attached
  • Descripción del producto
    Dual/ Single/ Triple -chamber implantable defibrillator
  • Manufacturer
  • 1 Event


  • 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.
  • Representante del fabricante
    Medtronic Saudi Arabia
  • Source