Events

Device Recall Enterra Gastric Electrical Stimulation System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Neuromodulation 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
    53086
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0088-2010
  • 사례 시작날짜
    2009-08-25
  • 사례 출판 날짜
    2009-10-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2012-05-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=84612
  • 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
    Intestinal stimulator - Product Code LNQ
  • 원인
    Medtronic is in the process of updating the enterra therapy labeling to include information regarding the risks of bowel obstruction and/or perforation. medtronic has received 15 reports since november 2002 of bowel obstruction and/or perforation of the bowel associated with enterra therapy system leads. of the 15 reported events, 11 required surgical intervention (all patients recovered withou.
  • 조치
    Medtronic Neuromodulation issued a "Medical Device Correction" letter beginning August 25, 2009 addressed to Healthcare Professionals. The letter described the Nature of the Issue, Scope, Potential Severity of the Issue, Enterra Therapy System labeling updating information warnings, Recommendations and other Additional Information. For further information, contact Medronic Neuromodulation Technical Services at 1-800-707-0933.

Device

Device Recall Enterra Gastric Electrical Stimulation System
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Gastroenterology-Urology Devices
  • 의료기기 등급
    HDE
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution.
  • 제품 설명
    Medtronic Enterra Therapy, Gastric Electrical Stimulation System, consisting of model 3116 Enterra Therapy Neurostimulator and model 4351 Unipolar Intramuscular Lead. Medtronic, Inc., 710 Medtronic Parkway, Minneapolis, MN 55432-5604 USA. || The Neurostimulator (implantable neurostimulator or INS) is a multiprogrammable device designed to deliver therapy through gastric electrical stimulation when connected to a lead system. Humanitarian Device: Authorized by Federal Law for use in treatment of chronic intractable (drug refractory) nausea and vomiting secondary to gastroparesis of diabetic or idiopathic etiology.
  • Manufacturer
    Medtronic Neuromodulation

Manufacturer

Medtronic Neuromodulation
  • 제조사 주소
    Medtronic Neuromodulation, 7000 Central Ave NE, Minneapolis MN 55432-3568
  • 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