Events

Amplia MRI Quad CRT0 SureScanClaria MRI Quad CRTD SureScanCompia MRI Quad CRTD SureScan 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Inc., Cardiac Rhythm and Heart Failure 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    76853
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2117-2017
  • 사례 시작날짜
    2017-04-12
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154406
  • 비고 / 경고
    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.
  • 데이터 추가 비고
    Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) - Product Code NIK
  • 원인
    An unexpected transient mode switch behavior was detected by medtronic during systems testing that affects amplia' "', claria'"', and compia'"' quad crt-d mri devices.
  • 조치
    Medtronic sent an Important Medical Device Information letter dated March 2017. The letter is addressed to Physician or Healthcare Professional. The letter describes the issue and the product involved in the recall. It informs consignees of the upcoming software update and provides directions in Appendix A on how to apply the update to patient devices and to verify that devices are operating correctly.. For questions, contact your local Medtronic Representative or Medtronic Technical Services at 800-723-4636. *Recall has not been initiated in USA only in Japan. UPDATE: Consignees were sent an "Update to Medical Device Correction" letter dated April 2017on 4/26/2017. The letter was addressed to Physicians or Healthcare Professional. The letter informed consignees that the programmer software update is approved for installation. For questions, or if we can be of further assistance, please contact your local Medtronic Representative or Medtronic Technical Services at 800-723-4636. Recall was initiated in USA on 4/26/2017.

Device

Amplia MRI Quad CRT0 SureScanClaria MRI Quad CRTD SureScanCompia MRI Quad CRTD SureScan
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    USA: Nationwide including DC & PR. Worldwide- Distribution : Australia Egypt Ireland Morocco Austria Finland Israel Netherlands Bangladesh France Italy New Zealand Belgium Germany Japan Norway Brunei Darussalam Greece Jordan Oman Canada Guadeloupe Kuwait Poland Cayman Islands Hong Kong Lebanon Portugal Cyprus Hungary Luxembourg Denmark India Macedonia Reunion Dominican Republic Iran Malaysia Singapore
  • 제품 설명
    Amplia MRI Quad CRT-0 SureScan || Claria MRI Quad CRT-D SureScan || Compia MRI Quad CRT-D SureScan
  • Manufacturer
    Medtronic Inc., Cardiac Rhythm and Heart Failure

Manufacturer

Medtronic Inc., Cardiac Rhythm and Heart Failure
  • 제조사 주소
    Medtronic Inc., Cardiac Rhythm and Heart Failure, 8200 Coral Sea St NE, Mounds View MN 55112-4391
  • 제조사 모회사 (2017)
    Medtronic plc
  • 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
    USFDA