Events

Device Recall Eon Mini Neurostimulation Sysem 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
    56787
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2607-2011
  • 사례 시작날짜
    2011-05-24
  • 사례 출판 날짜
    2011-06-22
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-07-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94501
  • 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
    Defective battery was identified as cause for reports of inability to communicate or recharge the product.
  • 조치
    St. Jude Medical sent an "IMPORTANT MEDICAL DEVICE RECALL" letter dated May 24, 2011 to all affected customers. The letter describes the product, problem and actions to be taken by the customers. St. Jude Medical recommends no action be taken if the product serial numbers do not match the numbers listed in the letter. For product remaining in unimplanted inventory, customers are instructed to contact their SJM representative so that product may be returned and replacements be provided. For implanted product that matches the serial numbers, the Medical Advisory Board recommend not to unnecessarily explant the devices if they are functioning as intended. Replacement devices will be provided at no additional cost to the customer. A Product Reconciliation Form was attached to the letter for customers to complete and return any unused product to the St. Jude Medical Neuromodulation Division at 6901 Preston Road., Plano, TX 75024. Questions regarding this recall are directed to the customer's St. Jude Medical Neuromodulation Division Representative.

Device

Device Recall Eon Mini Neurostimulation Sysem
  • 모델명 / 제조번호(시리얼번호)
    Serial numbers 701029 through 13766511. Serial numbers containing supplier battery lot numbers 285 and below.
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution-- USA (nationwide) including PUERTO RICO and countries of AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, COLOMBIA, CYPRUS, CZECH REPUBLIC, DENMARK, FINLAND,FRANCE, GERMANY, GREECE, INDIA, IRELAND, ISRAEL, ITALY, JAPAN, KOREA, MEXICO, NETHERLANDS, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, TURKEY, and UNITED KINGDOM.
  • 제품 설명
    Eon Mini Neurostimulation (IPG) System Model 3788 || 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