Events

Device Recall DBS Pocket Adaptor 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
    74552
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2645-2016
  • 사례 시작날짜
    2016-06-23
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-09-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=147891
  • 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
    Stimulator, electrical, implanted, for parkinsonian tremor - Product Code MHY
  • 원인
    Due to the potential for pocket adaptor conductor wire fractures involving dbs pocket adaptor model 64001 and model 64002, a safety notification was sent to healthcare professionals to reinforce device specific labeling for the handling of pocket adaptors and system integrity checking during implant procedures.
  • 조치
    Consignees were sent on 6/23/2016 a "Medical Device Safety Notification," dated June 2016. The letter was addressed to Healthcare Professional. The letter described "Background" information on the problem and product involved in the recall. It also provided "Recommendations" which included "Implanting the pocket adaptor with the neurostimulator" and "Checking system integrity". For questions contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7 am - 6pm CST.

Device

Device Recall DBS Pocket Adaptor
  • 모델명 / 제조번호(시리얼번호)
    Notification is not lot specific.
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution.
  • 제품 설명
    DBS Pocket Adaptor, Model 64001 and Model 64002. || The Medtronic Models 64001 (1x4) and 64002 (2x4) Pocket Adaptors can be used as a part of a neurostimulation system for deep brain stimulation. The pocket adaptor is intended to be implanted with the new replacement neurostimulator in the same pocket used for the explanted neurostimulator. Implanting in the same neurostimulator pocket allows for a single-incision procedure.
  • Manufacturer
    Medtronic Neuromodulation

Manufacturer

Medtronic Neuromodulation
  • 제조사 주소
    Medtronic Neuromodulation, 7000 Central Ave, Minneapolis MN 55421-1241
  • 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