Events

Device Recall Medtronic, Model 8870, Application Software Card 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
    61391
  • 사례 위험등급
    Class 2
  • 사례 연번
    Z-1338-2012
  • 사례 시작날짜
    2012-03-12
  • 사례 출판 날짜
    2012-03-30
  • 사례 상황
    Terminated
  • 사례 국가
    United States
  • 사례 종료 날짜
    2016-04-29
  • 사례 출처
    USFDA
  • 사례 출처 URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=107986
  • 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 has confirmed that an algorithm used in the model 8870 application card software has resulted in nine (9) occurrences of an incorrectly displayed schedule to replace the pump by date. it is estimated that there are more than 140,000 synchromed ii pump implants worldwide. a patient with a pump reaching eos prior to replacement may experience the return of underlying symptoms and/or wit.
  • 조치
    Medtronic mailed an "Urgent Medical Device Correction " letter addressed to Dear Healthcare Professional on March 12, 2012. The letter described the problem, Background, Clinical Manifestations, Recommendations, and Additional Information. To ensure there is no interruption in therapy, pump replacements should be scheduled before the ERI alarm sounds and the pump reaches its 7-year end of service. Customers were advised to forward the Urgent Medical Device Correction letter to patients whose name appears on their Pump Replacement List. Reimbursement SupportFor assistance with prior authorization, contact Medtronic Reimbursement at the numbers below: Therapy for Severe Spasticity: (800) 292-2903 Pain Therapies: (866) 962-9909 For questions regarding the letter call 800-328-0810.

Device

Device Recall Medtronic, Model 8870, Application Software Card
  • 모델명 / 제조번호(시리얼번호)
    All Model 8870 software application cards containing SynchroMed II software are in scope for this action.
  • 의료기기 분류등급
    General Hospital and Personal Use Devices
  • 의료기기 등급
    3
  • 이식된 장치?
    Yes
  • 유통
    Nationwide Distribution
  • 제품 설명
    Medtronic, Model 8870, Application Software Card is part of the SynchroMed¿ II Drug Infusion System. The System includes the SynchroMed¿ II implantable drug infusion pump 8637-20, 8637-40, N'Vision clinical programmer 8840 and the Software application card 8870. || The SynchroMed II Infusion system contains and administers prescribed drugs to a specific site inside patient body. The SynchroMed II Pump is supplied in 20 ml and 40 ml reservoir sizes. In the United States, the SynchroMed II Pump is specifically approved for (indicated): ¿ The chronic epidural/intrathecal infusion of Infumorph (preservative-free morphine sulfate sterile solution) in the treatment of chronic intractable pain. ¿ The chronic intrathecal infusion of Lioresal Intrathecal (baclofen injection) in the management of severe spasticity. ¿ The chronic intrathecal infusion of Prialt (preservative-free ziconotide sterile solution) for the management of severe chronic pain. ¿ The chronic intravascular infusion of floxuridine (FUDR) for the treatment of primary or metastatic cancer. ¿ The chronic intravascular infusion of methotrexate for the treatment of primary or metastatic cancer. Outside of the United States, the SynchroMed II Pump is indicated for the chronic infusion of drugs or fluids tested as compatible and listed in the product labeling for the specific geographies.
  • 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