INSIGNIA, NEXUS, CONTAK RENEWAL TR, CONTAK RENEWAL TR 2, VENTAK PRIZM 2 VITALITY, VITALITY 2 를 위한 안전성 경고 / 현장 안전성 서한

Medicines and Healthcare products Regulatory Agency에 따르면, 해당 안전성 경고 / 현장 안전성 서한 는 United Kingdom 에서 manufacturer #17429 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 ID
    MDA/2006/038
  • 사례 연번
    CON2024060
  • 날짜
    2006-07-13
  • 사례 국가
  • 사례 출처
    MHRA
  • 사례 출처 URL
  • 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
  • 원인
    Recall due to component failure. guidant has informed mhra that a sub-set of the implantable pacemaker/defibrillators listed above may suffer degradation of a high-stability low-voltage capacitor leading to device malfunction or premature battery depletion. prevalence of device malfunction in the future and the mean time to failure have not yet been established. contaminated material used in the manufacturing process of a low-voltage capacitor for these devices can cause a leakage of current resulting in appropriate device behaviour or premature battery depletion. one or two of these capacitors are used in each device depending on device design. guidant has identified the actual failure mechanism and corrective action has now been implemented. based on experience of reported incidents, capacitor failure is likely to occur in the early part of the device's life period; however it is not possible to estimate when capacitor failure will occur. analysis is ongoing to improve understanding of the prevalence and the time to failure of these devices. to date guidant has confirmed 5 reports of device malfunction associated with this issue out of approximately 27,200 implanted devices worldwide. one device malfunction was discovered at the time of implant; in the other four reports the devices required replacement. to date, approximately 1,500 potentially affected devices have been distributed in the uk and the republic of ireland. guidant believe that the majority of these have already been implanted. approximately 49,800 affected devices have been distributed worldwide. guidant issued a letter with patient management recommendations to clinicians in the uk on 28/06/06 (see appendix 1 in pdf).
  • 조치
    See actions on Page 3. Do not implant affected devices. (See list of affected serial numbers distributed in the UK and the Republic of Ireland on our website) Immediately quarantine all affected devices and return them to Guidant in accordance with their instructions. Identify patients implanted with affected devices and review them as soon as possible, giving priority to those who are device dependent or who have not been followed up within the last three months. During follow-up, verify device function using normal programmer follow-up procedures, checking for: no telemetry/pacing output ERI or EOL indications suspected premature battery depletion For specific model families, possible device malfunction behaviours may include (but are not limited to): Incomplete or missing PRM daily measurements Gas gauge not indicating BOL when checked at six month follow-up where the device is not programmed to high output settings Fault code 11 upon interrogation Gas gauge not indicating BOL when checked at six month follow-up where the device is not programmed to high output settings Battery voltage less than 3.10 V within six months of implant Abnormal P&R wave measurements Abnormal signals and markers on real-time or stored electrogram, which may result in inappropriate sensing and therapy *Not distributed within Europe Consult Guidant if you identify any of the above. Consider the risks and benefits of elective device replacement in device dependant patients if any of the above is confirmed. Schedule future patient follow-ups at intervals of no longer than three months for early detection of device failure. Instruct patient to contact their follow-up centre immediately or go to a hospital Accident and Emergency department if they experience a slow heart rate, syncope/light-headedness, inappropriate therapy or new or increased symptoms of heart failure. Report all instances of device failure to MHRA and Guidant. Report explants to the National Pacing and ICD Database (see Contacts on page 4).

Device

  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Guidant implantable pacemaker and implantable defibrillator families: INSIGNIA, NEXUS, CONTAK RENEWAL TR, CONTAK RENEWAL TR 2, VENTAK PRIZM 2 VITALITY, VITALITY 2 - See list of affected serial numbers distributed in the UK and the Republic of Ireland on our website. *Not distributed within Europe A comprehensive list of serial numbers of affected devices distributed in the UK and the Republic of Ireland is available on our website.
  • Manufacturer

Manufacturer