Events

Device Recall Percutaneous Trial Lead Kits 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 St. Jude Medical, 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
    69025
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2718-2014
  • 사례 시작날짜
    2014-07-29
  • 사례 출판 날짜
    2014-09-29
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2015-08-21
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129365
  • 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, implanted (pain relief) - Product Code GZB
  • 원인
    The directions for use (dfu) manual contains information for devices that are not approved in the us. the correct us approved versions of the manuals were sent to the customers to replace the incorrect international manuals.
  • 조치
    A field action was initiated with customer letters, dated July 29, 2014, and attached replacement DFUs. The letter identified the affected product and the reason for the recall. The recalling firm requested the consignees refer to the replacement DFU for guidance while using the device, and to discard the international manuals. Questions regarding the letter should be directed to customers' St. Jude Neuromodulation Representative or call the Technical Services Department at 1-800-727-7846.

Device

Device Recall Percutaneous Trial Lead Kits
  • 모델명 / 제조번호(시리얼번호)
    Material 100077113, Batch 4558337
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    Distributed in the states of Texas and Illinois.
  • 제품 설명
    Percutaneous Trial Lead Kit Model 3046 (4 ch percutaneous lead). || Used as part of the St. Jude Medical Neurostimulation system indicated for Spinal Chord Stimulation.
  • Manufacturer
    St. Jude Medical, Inc.

Manufacturer

St. Jude Medical, Inc.
  • 제조사 주소
    St. Jude Medical, 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