Events

Eon Mini 3788 (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
    63154
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0025-2013
  • 사례 시작날짜
    2012-09-04
  • 사례 출판 날짜
    2012-10-09
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2014-05-12
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=112696
  • 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
    Eon mini ipgs manufactured in april 2012 could potentially exhibit a sudden, brief surge in stimulation that would be felt by the patient as uncomfortable or painful. sjms routine testing, monitoring, and analysis of manufacturing processes identified three lots of eon mini ipgs that the internal battery has the potential to come into contact with the internal microcontroller board.
  • 조치
    ST. Jude Medical sent an important Medical Device Advisory letter dated September 4, 2012 to all affected customers. The letter identified the affected product, problem and recommended actions to be taken. For questions contact your St. Jude Medical Neuromodulation Division Representative or call the Technical Services Department at 1-800-727-7846.

Device

Eon Mini 3788 (IPG)
  • 모델명 / 제조번호(시리얼번호)
    Eon Mini - 3788 (IPG), Multiple Serial Numbers
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    US Nationwide Distribution
  • 제품 설명
    The Eon Mini Implantable Pulse Generator (IPG) is a 16-channel, rechargeable, multi-program system that allows the connection of one or two leads with four, eight, and 16 electrode leads. It is powered by a hermetically sealed battery within a titanium case. It uses microelectronic circuitry to generate constant current electrical stimulation. Stimulation programs can be delivered as either single stimulation or MultiStim programs depending on patients need. || Product Usage: || Eon Mini system is indicated as an aid in the management of chronic intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following: failed back surgery syndrome, intractable low back and leg 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