Events

Device Recall Deep Brain Stimulation (DBS") Lead Kits 의 리콜

U.S. Food and Drug Administration에 따르면, 해당 리콜 는 United States 에서 Medtronic Neuromodulation 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
    49446
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-0187-2009
  • 사례 시작날짜
    2008-06-14
  • 사례 출판 날짜
    2008-10-27
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2011-12-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=73449
  • 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
    Lead - Product Code MHY
  • 원인
    Medtronic has received reports of dbs" leads being damaged at the proximal connector end of the lead when the lead cap is used in the implant procedure. the lead damage is the result of excessive torsion and / or tensile lading of the proximal connector end of the lead. data also suggest that excessive torque while tightening or loosening the setscrews may twist the setscrew connector block and d.
  • 조치
    Consignees were sent a "Medtronic Urgent: Medical Device Correction" letter 8/2008. The letter addressed to Healthcare Professionals, described the product involved, explanation of the issue, recommendations for Implant and included an attachment "Updated Instructions for Using the Lead Cap". Contact Medtronic Neuromodulation at 1-800-707-0933 for assistance.

Device

Device Recall Deep Brain Stimulation (DBS") Lead Kits
  • 모델명 / 제조번호(시리얼번호)
    PIN 3389028103, 33890400103, and 338904004V
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    AL, AZ, AR, CA, CO, CT, FL, DC, GA, HI, ID, IL , IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO, MT, NE , NV, NH, NJ, NM, NY, NC, ND, OH, OR, OK, PA, RI, SC, SD, TN, TX, UT , VT, VA, WA, WV, and WI. ALGERIA, AUSTRALIA, AUSTRIA, BELGIUM, BRAZIL, CANADA, CROATIA, CYPRESS, CZECH REPUBLIC, DENMARK, EGYPT, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, INDIA, IRELAND, ISRAEL, ITALY, JORDAN, LEBANON, LUXEMBOURG, MEXICO, MOROCCO, NETHERLANDS, NORWAY, POLAND, PORTUGAL, PUERTO RICO, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWEEDEN, SWITZERLAND, TUNISIA, TURKEY, UNITED ARAB EMIRATES, and UNITED KINGDOM.
  • 제품 설명
    Medtronic DBS" 3389 Lead Kit for Deep brain stimulation, DBS Leads: Proximal 40 mm, Distal 9.0 mm, Medtronic, Inc. || Medtronic Active Therapy includes Activa Parkinson's Control Therapy and Activa Tremor Control Therapy. Parkinson's Control Therapy: Bilateral stimulation of the internal globus pallidus (GP) or the subthalamic nucleus (STN) using Medtronic Activa Parkinson's Control Therapy is indicated for adjunctive therapy in reducing some of the symptoms of advanced, levodopa-responsive Parkinson's disease that are not adequately controlled with medication. Tremor Control Therapy: Unilateral thalamic stimulation by the Medtronic Activa Tremor control system is indicated for the suppression of tremor in the upper extremity. The system is intended for using patients who are diagnosed with Essential Tremor or Parkinsonian tremor not adequately controlled by medications and where the tremor constitutes a significant functional disability.
  • Manufacturer
    Medtronic Neuromodulation

Manufacturer

Medtronic Neuromodulation
  • 제조사 주소
    Medtronic Neuromodulation, 800 53rd Ave NE, PO Box 1250, Minneapolis MN 55440-1250
  • Source
    USFDA