Events

SynchroMed II Implantable Drug Infusion System 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
    75486
  • 사례 위험등급
    Class 1
  • 사례 연번
    Z-0788-2017
  • 사례 시작날짜
    2016-10-03
  • 사례 출판 날짜
    2016-12-19
  • 사례 상황
    Open, Classified
  • 사례 국가
    United States
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=150480
  • 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 is following up to a may 2013 communication regarding the priming bolus function for the synchromed infusion system. medtronic is updating the model 8870 software application card (to version aau01) and the synchromed pump labeling to address the priming bolus issue.
  • 조치
    Medtronic Representatives began visiting consignees on 10/3/2016 to replace previous version Model 8870 software application cards, contained within the model 8840 NVision Clinician Programmer, with the updated version (new version is AAU01). Beginning October 20, 2016, Implanting and Following physicians were sent an Urgent Medical Device Correction letter dated September 2016, . This letter to physicians is informing them of the updated Model 8870 software application card, and changes to SynchroMed infusion system labeling. A response form is requested to be returned to Medtronic. Customers with questions were instructed to contact Medtronic Neuromodulation Technical Services at 1-800-707-0933.

Device

SynchroMed II Implantable Drug Infusion System
  • 모델명 / 제조번호(시리얼번호)
    software application cards with versions other than AAU01
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Worldwide Distribution - (US Nationwide) Internationally to Germany, Greece, Australia, United Kingdom, Switzerland, Italy, Norway, France, Canada, and Malta.
  • 제품 설명
    Medtronic SynchroMed II Implantable Drug Infusion System. This system includes: Model 8870 Software Application Card, Model 8840 N'Vision Clinician Programmer, and Model 8637 SynchroMed II Implantable Drug Infusion Pump (supplied in 20 ml or 40 ml reservoir size.) || Product Usage: || The SynchroMed II Programmable Pump is indicated when patient therapy requires the chronic infusion of the following drugs or fluids: Chronic intraspinal (epidural and intrathecal) infusion of preservative-free morphine sulfate sterile solution in the treatment of chronic intractable pain, Chronic intrathecal infusion of preservative-free ziconotide sterile solution for the management of severe chronic pain, Chronic intrathecal infusion of Lioresal Intrathecal (baclofen Injection ) in the management of serve spasticity, Chronic Intravascular Infusion of Floxuridine (FUDR) or methotrexate for the treatment of primary or metastatic cancer
  • Manufacturer
    Medtronic Neuromodulation

Manufacturer

Medtronic Neuromodulation
  • 제조사 주소
    Medtronic Neuromodulation, 7000 Central Ave, Minneapolis MN 55421-1241
  • 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