Events

SynchroMed EL models 8626 and 8627 and SynchroMed II model 8637 implantable drug pumps 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 Medtronic 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

현장 안전성 서한은 의료기기 제조사 또는 제조사 대리인이 시중에 유통되고 있는 자사 의료기기 제품에 대하여 취할 수 있는 조치를 알리는 소통방식입니다. 주요 대상층은 보건의료업계 종사자와 의료기기 사용자들입니다. 여기에는 회수(recall) 조치와 경고도 포함될 수 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert / Field Safety Notice
  • 사례 연번
    MDA/2008/087
  • 날짜
    2008-12-18
  • 사례 출판 날짜
    2014-12-17
  • 사례 국가
    United Kingdom
  • 사례 출처
    MHRA
  • 사례 출처 URL
    https://www.gov.uk//drug-device-alerts/medical-device-alert-synchromed-el-models-8626-and-8627-and-synchromed-ii-model-8637-implantable-drug-pumps-scan-patients-with-these
  • 비고 / 경고
    Data from the United Kingdom is current through April 2019. All of the data comes from the Medicines and Healthcare products Regulatory Agency, except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of recall data from the U.S. and the United Kingdom.
  • 데이터 추가 비고
    Risk of delays in the resumption of drug infusion and in the logging of motor stall events following MRI scanning.Medtronic have found that the SynchroMed EL and SynchroMed II drug pumps do not behave as expected when they are exposed to the magnetic field of an MRI scan. The product labelling states that the magnetic field of an MRI scan will temporarily stop the rotor of the pump and suspend drug infusion for the duration of the MRI exposure for all SynchroMed pumps. The pump should resume normal operation when removed from the MRI magnetic field. However, the following issues have been found:potential delay in resumption of drug infusion following an MRI scan (both models)
    potential for pump programming to be altered (both models)
    delay in logging of motor stall in the pump memory (SynchroMed II only)
    delay in detecting motor stall recovery (SynchroMed II only)There have been nine reported incidents of motor stall and 70 reports of event logging errors worldwide to date.No patient deaths or serious injuries have been reported as a result of these problems.
  • 원인
    (medtronic) risk of delays in the resumption of drug infusion and in logging of motor stall events after mri scans. (mda/2008/087).
  • 조치
    Ensure that departmental procedures are in place for the scanning of patients with Medtronic SynchroMed implantable drug pumps. Where prior consultation with pump management staff has not been possible, consider:alternative imaging techniques if appropriate more regular observations of the patient until confirmation that the pump has restarted.For all personnel involved in the care of patients with these pumps:Follow manufacturer’s advice regarding these risks (see appendix)Before MRIEnsure that an assessment has been undertaken to determine whether the patient could be safely deprived of their drug for the duration of the scan and until the pump can be interrogated Ensure there is a Medtronic N’Vision programmer available to interrogate the pump as soon as possible after an MRI scan (and X-ray facilities for roller study on SynchroMed EL)After MRIEnsure that the patient and pump are reviewed promptly following scanning to confirm that therapy has resumed and that pump programming has not been affected. This could include: close observation for signs of drug underdosing for patients implanted with SynchroMed II pumps, interrogate the pump with the N’Vision programmer. If motor stall and recovery has not been confirmed after a second interrogation, contact the manufacturer for further advice for patients implanted with SynchroMed EL pumps, interrogate the pump to identify whether programming has been affected and consider carrying out a roller study (as described in the IFU) to confirm that drug infusion has resumed Before carrying out any medical intervention (e.g. administering a drug bolus or explanting the pump) consider the possibility of extended motor stall Do not discharge patients until you have verified that normal drug infusion has resumed Contact the manufacturer for advice if in doubt about pump status Report drug pump incidents to the manufacturer and the MHRA

Device

SynchroMed EL models 8626 and 8627 and SynchroMed II model 8637 implantable drug pumps
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Implantable drug pumps manufactured by Medtronic – SynchroMed EL models 8626 and 8627 and SynchroMed II model 8637.
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 제조사 주소
    Enquiries to the manufacturer should be addressed to:Dr David Dunham Regulatory Affairs Manager – UK & Ireland Medtronic Limited Suite One Sherbourne House Croxley Green Business Park Watford WD18 8WW Tel: 01923 212213 Fax: 01923 241004E-mail: david.dunham@medtronic.com
  • 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
    MHRA