Events

Device Recall Nexdrive Micropositioning Drive 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
    68615
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2118-2014
  • 사례 시작날짜
    2014-06-11
  • 사례 출판 날짜
    2014-07-25
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-01-22
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128310
  • 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
    Neurological stereotaxic Instrument - Product Code HAW
  • 원인
    Potential for misalignment of the z-stage scale. using one of these devices for a procedure could result in the microelectrode being inserted to an incorrect target depth.
  • 조치
    Medtronic sent an Urgent Medical Device Recall letter dated June 2014 on June 11, 2014, to all affected customers. The letter described the problem and the product involved in the recall. The letter described the "Action Requested" which included to stop using and return the recalled device and to complete and return the Reply Form. Customers with questions were instructed to contact Medtronic Neuromodulation Technical Services at 1-800-707-0933. EXPANDED 10/02/2014: Medtronic sent an Urgent Medical Device Recall letter beginning 10/02/2014. The letter explained that this letter is an update to the June 2014 action, to include 4 additional lot numbers. The letter explained the reason for recall identified all lots recalled and asked that devices stopped being used. A response form provided instructions on how to return product and the form was asked to be returned within 10 days. Questions should be directed to Medtronic Neuromodulation Technical Service at 1-800-707-0933, weekdays 7 am - 6 pm, Central time.

Device

Device Recall Nexdrive Micropositioning Drive
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 082605614, 082601414, 082602014, 082634313, 082630913, 082629713, 082629613, 082626913, 082623113, 082621413, and 082618213.   EXPANDED 10/02/2014 Lot Numbers: 082616214, 082616314, 082618314, and 082618414.
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Worldwide Distribution - USA including CA, CO, FL, IL, KS, KY, LA, MN, MT, NC, NE, OR, TX, VA, and UT, and Internationally to Canada, Spain, and United Kingdom.
  • 제품 설명
    Medtronic Nexdrive Micropositioning Drive. Models Ml-1000 and Ml-2000. || For use in conjunction with the Medtronic Nexframe Stereotactic System for the precise positioning of microelectrodes and implantable leads. A stereotactic guidance system used in conjunction with Medtronic StealthStation Navigation Systems-image-guided surgery (IGS) systems-for Deep Brain Stimulation (DBS) procedures.
  • 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