Events

Device Recall Medtronic Activa Deep Brain Stimulation System 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Inc, Neurological & Spinal Division 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
    34156
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0370-06
  • 사례 시작날짜
    2005-11-30
  • 사례 출판 날짜
    2006-01-10
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2006-12-28
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=43204
  • 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, Electrical, Implanted, For Parkinsonian Tremor - Product Code MHY
  • 원인
    A safety concern exists regarding the medtronic activa deep brain stimulation system instructions for performing mri (magnetic resonance imaging). medtronic's instructions have until now recommended a use of a displayed mri head specific absorption rate (sar) of not more than 0.4 w/kg. the recommended maximum displayed head sar is now 0.1 w/kg.
  • 조치
    The firm''s recall consists of providing revised instructions for the Activa DBS. The revision modifies the recommended SAR to use during MRI of patients who have an Activa DBS. Use of the Activa DBS is otherwise unaffected by this recall. A Dear Healthcare Provider letter and MRI Radiologist letter were sent on 11/30/05 and 12/05/05 to provide this information.

Device

Device Recall Medtronic Activa Deep Brain Stimulation System
  • 모델명 / 제조번호(시리얼번호)
    All serial numbers and Lot codes are affected.
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide and OUS to includeCanada, Europe, Middle East, Africa, Japan, Asia-Pacific, Australia - New Zealand, Latan America
  • 제품 설명
    Medtronic Activa Deep Brain Stimulation (DBS) system including the following system components: Model 7424 Itrel II Neurostimulator (DBS applications only); Model 7426 Soletra Neurostimulator; Model 7428 Kinetra Neurostimulator; Models 3387, 3389 DBS Leads; and Models 7482,7495 DBS Extensions. Medtronic, Inc. 710 Medtronic Parkway, Minneapolis, MN 55432-5604, USA. The Medtronic Activa System is an implantable, multiprogrammable system that delivers electrical stimulation to selected areas of the brain. The Neurostimulator generates electrical signals that are transmitted to the brain. These signals are delivered from the neurostimulator to the brain via Extension and Lead. These components comprise the implantable portion of the Activa System.
  • Manufacturer
    Medtronic Inc, Neurological & Spinal Division

Manufacturer

Medtronic Inc, Neurological & Spinal Division
  • 제조사 주소
    Medtronic Inc, Neurological & Spinal Division, 800 53rd Ave Ne, Columbia Heights MN 55421-1241
  • Source
    USFDA