Events

Deep Brain Stimulation Lead Kits and Dystonia Kits 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Medtronic 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

안전성 경고는 의료기기 제품과 관련된 중요한 정보와 권고사항을 담고 있습니다. 물론 안전성 경고가 배포되었다고 해서 해당 제품이 무조건 안전하지 않은 제품이라는 것은 아닙니다. 보건의료업계 종사자와 의료기기 사용자들에게 배포되는 안전성 경고에는 회수(recall)도 포함될 수 있습니다. 제조사가 안전성 경고를 작성하기도 하지만, 보건당국에서 작성하는 경우도 있습니다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Safety alert
  • 날짜
    2013-02-18
  • 사례 출판 날짜
    2013-02-18
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130218.html
  • 비고 / 경고
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), 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 data from the U.S. and Hong Kong.
  • 데이터 추가 비고
    Medical Device Safety Alert
  • 원인
    Medical device safety alert: medtronic deep brain stimulation lead kits and dystonia kits medical device manufacturer, medtronic international limited issued a medical device safety alert concerning the following products: deep brain stimulation (dbs) lead kits: models 3387, 3387s, 3389, 3389s, 3391, 3391s dystonia kits: models 3317, 3319, 3337, 3339 medtronic has received reports of dbs leads being damaged at the connector end of the lead when the lead cap is used. tightening or loosening of the setscrew may twist the setscrew connector block and may damage the proximal connector end of the lead. if this happens, the damage would most likely occur at lead contact no.3 which could affect electrode contact no.3. medtronic further explained that depending on the extent of lead damage and the need to use electrode no.3, lead replacement may be required or optimal therapy may not be provided. lead damage due to setscrew connector block twisting has been reported with 0.25% of the dbs leads distributed, however, this incidence is lower than the expected actual rate of occurrence since every event is not likely to have been reported and the actual number of uses of lead caps is unknown. according to the manufacturer, there have been no reports of permanent patient impairment, life-threatening injury, or death as a result of this issue. medtronic is working on corrective actions to reduce the occurrence of setscrew connector block twisting which may result in lead damage. physicians are reminded that every use of the lead cap provides an opportunity for lead damage to occur. the local supplier confirmed that the affected products have been distributed in hong kong. they will send a letter to relevant physicians to inform them of the risk of lead damage and the actions that should be taken to mitigate occurrence. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 18 february 2013.

Device

Deep Brain Stimulation Lead Kits and Dystonia Kits
  • 모델명 / 제조번호(시리얼번호)
  • 의료기기 분류등급
    Neurological Devices
  • 제품 설명
    Medical Device Safety Alert: Medtronic Deep Brain Stimulation Lead Kits and Dystonia Kits
  • 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
    DH