IMPLANTABLE CARDIOVERSOR DEFIBRILLATOR ENTRUST. Registration Anvisa n ° 10339190257 (registration expired on 11/14/2010 and not renewed). 의 안전성 경고

Agência Nacional de Vigilância Sanitária (ANVISA)에 따르면, 해당 안전성 경고 는 Brazil 에서 MEDTRONIC COMERCIAL LTDA. 에 의해 제조된 제품과 관련되어 있습니다.

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안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 사례 ID
    1121
  • 날짜
    2012-03-27
  • 사례 국가
  • 사례 출처
    ANVISA
  • 사례 출처 URL
  • 비고 / 경고
    Brazilian data is current through June 2018. All of the data comes from Anvisa, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Brazil.
  • 데이터 추가 비고
    According to the company, a portion of EnTrust Implantable Cardioverter Defibrillators (CDI's) may not meet the expected longevity or provide at least three months of device operation between the Elective Replacement Indications (ERI) and their lifetime (EOL ), due to a faster than expected fall in battery voltage. The company has not received reports of patient death or serious injury as a result of this problem. The events reported refer to a drop in battery voltage from ~ 3.0 V to ERI (2.61 V) over a period of time ranging from approximately one week to six months. All events reported occurred at least 30 months after the implant. Medtronic has confirmed nine reports of time-out of the load circuit during automatic capacitor rebuilding and a report of loss of pacing, all occurring between the ERI and the explant moment. Although there is a potential risk of high voltage loss between ERI and the explant of the device, such fact has not been reported to date according to the company. Medtronic has identified the cause of these occurrences as being a short internal battery, which occurs as the battery capacity is consumed. #### Update (08/17/2012): The record holder finalized risk communication to users of the product, as reported to UTVIG (Exp .: 0441135 / 12-8).
  • 원인
    Premature battery drainage.
  • 조치
    Treatment recommendations: Physicians should keep routine follow-up sessions at least every three months in accordance with the instructions for use of the product. Patient alerts must also be programmed for "Low Battery Voltage ERI" and "Excessive Charge Time EOL" to ON and immediately replace devices after reaching ERI if the voltage reduction is faster than expected. Entity Proactive / Proactive Replacements are not recommended.

Manufacturer

  • 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
    ANVSANVISA