Events

Device Recall Medtronic SPECIFY 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
    48705
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-2241-2008
  • 사례 시작날짜
    2008-05-21
  • 사례 출판 날짜
    2008-09-18
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2010-10-08
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=71931
  • 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 kit for implanted spinal-cord stimulator (pain relief) - Product Code GZB
  • 원인
    Medtronic is recalling certain lots of model 3998 specify surgical lead kits due to a package mislabeling issue. the package labeling incorrectly states the lead length is 28 cm in length when it should state 20 cm. recalled lots are to be returned for replacement or credit.
  • 조치
    In May 2008, a Product Recall letter was issued to customers. Medtronic Field Representatives are to contact customers with consigned or unregistered sold product to remove it and return it to Medtronic. A Leave-Behind letter will be provided to customers, explaining the issue and the reason for removal of product. Recalled devices will be returned for replacement or credit. The Medtronic representative will complete and return a Reply Card, which documents the notification of the customer. If you have questions or comments, contact your Medtronic representative.

Device

Device Recall Medtronic SPECIFY
  • 모델명 / 제조번호(시리얼번호)
    V004442, V004456, V004457, V004541, V004644, V005789, V005838, V005884, V005952, V006010, V006011, V006497, V006610, V006732, V006888, V006937, V007136, V007224, V007342, V007451, V007565, V007729, V007781, V007911, V008174, V008257, V008387, V008638, V008639, V008729, V008902, V009060, V009191, V009278, V009352, V009353, V009630, V010099, V010124, V010125, V010366, V010367, V010602, V010744, V010896, V011057, V011091, V011215, V011257, V011299, V011406, V011457, V011552, V011610, V011627, V011860, V011958, V011977, V012040, V012123, V012202, V012238, V012260, V012411, V012571, V012618, V012935, V013158, V013231, V013331, V013489, V013615, V013745, V013787, V013837, V013862, V014190, V014320, V014426, V014454, V014660, V014785, V015071, V015166, V015327, V015626, V016195, V016445, V016489, V017182, V017731, V017927, V019145, V019452, V019569, V019909, V020188, V020688, V020904, V021560, V021753, V022880, V023339, V023517, V025268, V025500, V025707, V026020, V026436, V027462, V027804, V028474, V029383, V029983, V030442, V031317, V032070, V032560, V034825, V034832, V035769, V036156, V036810, V036857, V038530, V041066, V041365, V042627, V043757, V043759, V044336, V044850, V045723, V047365, V050371, V052566, V053142, V054607, V056045, V057371, V060415, V062321, V068860, V069647, V077531, V080086, V082162, V084570, V086942, V090294, V091959, V095777, V102426
  • 의료기기 분류등급
    Neurological Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    Yes
  • 유통
    US distribution only to: AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MO, MN, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY
  • 제품 설명
    Medtronic SPECIFY, 3998, Lead Kit for Spinal Cord Stimulation (SCS). Manufactured at Medtronic, Inc., Villalba, Puerto Rico, USA. Contents of the inner package are STERILE. Method of sterilization: Ethylene Oxide. Model 3998 lead is an implantable, permanent lead. It is used to deliver electrical pulses to the dorsal aspect of the spinal cord. The lead consists of two polyurethane lead bodies joined to one silicone rubber paddle. The lead has two parallel rows of four platinum iridium electrodes on the distal end.
  • Manufacturer
    Medtronic Neuromodulation

Manufacturer

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