Events

Device Recall SynchroMed II implantable infusion pump 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
    63712
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0497-2013
  • 사례 시작날짜
    2012-11-09
  • 사례 출판 날짜
    2012-12-13
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2017-12-31
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=114599
  • 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
    Pump, infusion, implanted, programmable - Product Code LKK
  • 원인
    Medtronic notified healthcare professionals of the impact of unapproved drugs on the performance of the synchromed infusion pump system. use of unapproved drugs with synchromed pumps can result in an increased risk of permanent motor stall and cessation of drug infusion. update 2/1/2016: medtronic received approval to incorporate enhancements to the synchromed ii pump which decreases the potential for internal electrical shorting and motor corrosion, and is retrieving any unused pumps.
  • 조치
    The firm Medtronic, sent an "Urgent medical Device Safety Notification" dated November 2012, to its customers beginning November 09, 2012. The letter described the product, problem and actions to be taken. The customers were instructed to follow the recommendations provided in the letter and complete and return the PHYSICIAN REPLY FORM via mail at Medtronic Neuromodulation Quality Assurance, 7000 Central Ave NE, Mailstop RCC150, Minneapolis, MN 55432; fax to: 800-897-3899 or email to: neuro.quality@medtronic.com. If you have questions, please contact Medtronic Neuromodulation Technical Services at 1-800-707-0933 weekdays 7am - 6pm CST. UPDATE 2/1/2016: Medtronic began notifying consignees 2/1/2016 via, mail, telephone and/or in person visit by a Medtronic Field Representative. The Medtronic Field Representatives will retrieve devices in the US and provide an Urgent Medical Device Removal letter. The letter states that device design has been updated and the Medtronic Field Representative has retrieved any devices with a Use By date on or before 5/14/2017. An account specific Customer Confirmation Form was to be completed by either the Medtronic Field Representative or the consignee. Consignees with questions can contatct their Medtronic Field Representative, or Customer Service at 1-888-854-0978.

Device

Device Recall SynchroMed II implantable infusion pump
  • 모델명 / 제조번호(시리얼번호)
    All SynchroMed EL and SynchroMed II pumps
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide distribution: USA (nationwide) and countries including: Canada and Mexico.
  • 제품 설명
    Medtronic SynchroMed II, Model 8637, (The SynchroMed¿ II Pump is supplied in 20 ml or 40 ml reservoir size.) Sterilized using ethylene oxide. The pump is part of an infusion system that stores and delivers a prescribed drug to a specific site. The implantable components of the SynchroMed II Infusion System include the pump, catheter, and catheter accessories.
  • Manufacturer
    Medtronic Neuromodulation

Manufacturer

Medtronic Neuromodulation
  • 제조사 주소
    Medtronic Neuromodulation, 7000 Central Ave NE, Minneapolis MN 55432-3568
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    USFDA