Events

Medical device alert 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/2007/078
  • 날짜
    2007-10-19
  • 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-sprint-fidelis-implantable-cardioverter-defibrillator-icd-lead-reports-of-lead-conductor-fracture
  • 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
    ICD lead recall due to risk of inappropriate patient shocks, loss of defibrillation therapy and/or loss of pacing output, caused by fracture of the lead conductor.The MHRA has received 23 reports of lead conductor fracture for the above models (6930, 6931, 6948 6949), among approximately 6900 leads distributed in the UK. This includes one ongoing investigation of a fatality which may have been a consequence of lead fracture. Fractures typically occur at two main sites on the lead: one at the ring electrode affecting the anode conductor; the second near the anchoring sleeve tie-down affecting the cathode conductor and occasionally the high voltage conductor.UK incident reports have included:delivering a number of inappropriate shocks
    oversensing caused by noise on the lead
    an increase in the pace/sense or shock lead impedanceMedtronic has informed the MHRA that it is suspending distribution of all models of the Sprint Fidelis lead and is recalling all un-implanted stock. The company communicated this to all its customers in its ‘Urgent Medical Device Information’ issued on 15 October 2007. This provides important programming advice to help increase the chance of early detection of lead fracture, and reduce the risk of inappropriate therapy. However, it is important to note that all ICD leads, not only Medtronic’s Sprint Fidelis models, are associated with a small risk of conductor fracture once implanted, and the steps identified in Medtronic’s notice would not necessarily identify fractures in all cases.Medtronic had previously issued a ‘Physician Information Letter’ on this lead family in March 2007. Their investigations at that time concluded that variables within the implant procedure may pre-dispose the lead to fracture, with severe bending or kinking of the lead during implantation using the venous access location identified as a risk factor.
  • 원인
    (medtronic) 23 reports of lead conductor fracture for models (6930, 6931, 6948 and 6949), of around 6,900 leads in the uk including an investigation into a fatality. (mda/2007/078).
  • 조치
    Do not implant any Sprint Fidelis ICD leads (models listed above). Identify and return to Medtronic any of these leads which have not been implanted. Identify all patients implanted with affected models and arrange a follow-up as soon as practicable (within 8 weeks). Ensure programming parameters are set to maximise the chance of detecting lead fractures and avoiding inappropriate therapy (in accordance with manufacturer’s advice). Remind patients of the importance of contacting their follow-up clinic as soon as possible in the event of therapy delivery and/or the onset of any audible patient alert. Follow up patients at 3-month intervals.Clinicians shouldFollow up all patients as soon as practicable, ideally within eight weeks. Review the following parameters which can indicate lead fracture: number of inappropriate shocks oversensing and noise on the RV Lead an increase in the lead impedance an increase in the noise sensing on the noise integrity counter. Consider provocative testing (eg shoulder/arm movements, and deep respiration by the patient), which may help confirm a suspected lead fracture, although this diagnostic method should not be relied upon alone. Programme the patient’s ICD where appropriate to the following parameters as outlined in Medtronic’s ‘Urgent Medical Device Information’: To reduce inappropriate shocks due to oversensing: Program VF detection for initial number of intervals to detect (NID) to nominal settings (18/24) or longer at clinical discretion and redetect NID to nominal settings of (12/16). Where clinically appropriate increase the number of intervals to detect in the VT zones. To increase the chance of detection of lead fracture Turn ON patient alert pacing, RV and SVC defibrillation impedance. To optimise effectiveness of the lead impedance alert: Review V pacing lead performance trend to determine typical chronic impedance value for the patient (typical values for Fidelis leads should be 350-1,000 ohms). Programme lead impedance alert threshold for RV pacing to 1,000 ohms if the typical chronic impedance for the patient is ≤ 700 ohms, or Programme lead impedance alert threshold for RV pacing to 1,500 ohms if the typical chronic impedance for the patient is > 700 ohms. Programme lead impedance alert threshold for RV defibrillation and SVC defibrillation to 100 ohms.Remind patients to contact their follow-up centre immediately after they have received a delivery of therapy or when they are alerted by a ‘BEEP’ from their patient alert.Follow up patients at 3-month intervals, in line with Medtronic’s standard patient follow-up recommendation in their ICD physicians’ manuals.Consider the relative risks of lead extraction against the risk of lead fracture on an individual patient basis. Replacement of fully functioning leads would not be appropriate except in unusual circumstances, in view of the significant risk associated with this procedure. However, it is important to note that the actions listed above can not be guaranteed to detect lead fractures in all cases.Report all instances of lead fracture to the MHRA and Medtronic.Report explants to the National Pacing and ICD Database (see contact on page 3).

Device

Medical device alert
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Implantable cardioverter defibrillator (ICD) lead. Sprint Fidelis manufactured by Medtronic, model numbers: 6930, 6931, 6948 and 6949.
  • Manufacturer
    Medtronic

Manufacturer

Medtronic
  • 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