Events

Device Recall Medtronic Virtuoso 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Inc. Cardiac Rhythm Managment 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
    52853
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1954-2009
  • 사례 시작날짜
    2009-07-27
  • 사례 출판 날짜
    2009-08-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84134
  • 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
    Implantable cardioverter defibrillator (Single Chamber) - Product Code LWS
  • 원인
    Medtronic has detected a specific pattern of mosfet ic malfunctions in its concerto, virtuoso and enrhythm family of devices. the probability of occurrence decreases with time and, to date over 90% of the malfunctions related to the pattern have occurred within the first twelve months after implant.
  • 조치
    Medtronic, Inc. personnel retrieved 2 non-implanted devices remaining at 2 hospitals. A Performance Notes letter was left at each facility. The Performance Notes described the issue, actions to address issue and recommendations to physicians. The Performance Notes will also be posted on the firm's website. Direct questions about this recall to Medtronic, Inc. by calling 1-763-514-4000.

Device

Device Recall Medtronic Virtuoso
  • 모델명 / 제조번호(시리얼번호)
    Serial number: PUN421618H.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution-- (states of IA and NJ).
  • 제품 설명
    Medtronic Virtuoso VR, Model D154VWC, Single Chamber implantable cardioverter defibrillator with atrial therapies. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. || This device is indicated to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias in patients with NYHA functional Class II/III heart failure.
  • Manufacturer
    Medtronic Inc. Cardiac Rhythm Managment

Manufacturer

Medtronic Inc. Cardiac Rhythm Managment
  • 제조사 주소
    Medtronic Inc. Cardiac Rhythm Managment, 8200 Coral Sea St. N.E., Mounds View MN 55112
  • 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