InSync® III Cardiac Resynchronization Therapy Pacemakers (CRT-P)

제조사

  • 제조사 모회사 (2017)
  • 제조사 의견
    “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
    AMPMDRS

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데이터에 대해 더 자세히 알아보기 여기

  • 모델명 / 제조번호(시리얼번호)
    Models 8042, 8042B, 8042U
  • 제품 설명
    multi-programmable, rate responsive, implantable AV synchronous biventricular pacing device for cardiac resynchronization.
  • Manufacturer
  • 모델명 / 제조번호(시리얼번호)
  • 이식된 장치?
    Yes
  • 제품 설명
    Active implantable medical devices - cardiac pacemakers
  • Manufacturer