Events

Eon Mini" Implantable Pulse Generator (IPG) 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Advanced Neuromodulation Systems, Inc 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
    55503
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1599-2010
  • 사례 시작날짜
    2010-04-23
  • 사례 출판 날짜
    2010-05-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-07-27
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=91001
  • 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, spinal-cord, totally implanted for pain relief - Product Code LGW
  • 원인
    Due to a missed inspection step during manufacturing, a small number of devices may experience a gradual or sudden loss of charging capability.
  • 조치
    St. Jude Medical issued an "Important Medical Device Information" notification dated April 2010. Consignees were informed of the affected product and instructed on necessary steps. Any returned product should be sent to the firm. For further information, contact your St. Jude Medical Neuromodulation Division Sales Representative or call 1-972-309-2154.

Device

Eon Mini" Implantable Pulse Generator (IPG)
  • 모델명 / 제조번호(시리얼번호)
    Device Code: 65-3788-01, Serial Numbers: 703271, 703287, 703050, 703051, 704169, 704476 and 704520.
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution -- GA, NC, CA, OK, SC and NJ.
  • 제품 설명
    Eon Mini Implantable Pulse Generator (IPG). Advanced Neuromodulation Systems, Inc. Plano, TX. || Indicated as an aid in the management of chronic, intractable pain of the trunk and/or limbs, including unilateral or bilateral pain.
  • Manufacturer
    Advanced Neuromodulation Systems, Inc

Manufacturer

Advanced Neuromodulation Systems, Inc
  • 제조사 주소
    Advanced Neuromodulation Systems, Inc, 6901 Preston Rd, Plano TX 75024-2508
  • 제조사 모회사 (2017)
    Abbott Laboratories
  • 제조사 의견
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    USFDA