Events

Deep Brain Stimulation (DBS) system pocket adaptors 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Medtronic Ltd 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
    2016-06-24
  • 사례 출판 날짜
    2016-06-24
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20160624a.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 neuromodulation deep brain stimulation (dbs) system pocket adaptors the medicines and healthcare products regulatory agency (mhra) of the united kingdom posted a medical device safety alert concerning metalline wound, drainage, tracheo dressings manufactured by lohmann & rauscher gmbh & co.Kg. medical device manufacturer, medtronic ltd, has issued a medical device safety alert concerning its neuromodulation deep brain stimulation (dbs) system pocket adaptors (models 64001 and 64002) which can be used with the implantable neurostimulators: activa pc (model 37601) and activa rc (model 37612). the manufacturer has identified sixteen dbs pocket adaptors that were returned for high impedance measurements and where subsequent manufacturer’s analysis identified conductor wire fractures in close proximity to the location where the adaptor wire exits the neurostimulator connector block. of the sixteen returned devices, two were returned after the issue was identified intraoperatively, and 14 were returned after the issue was identified post-implant (requiring revision surgery). according to the manufacturer, approximately 20,000 dbs pocket adaptors have been sold worldwide since product launch in 2009, for a 0.08% reported rate of occurrence. the design of the pocket adaptor conductor body is similar to that of dbs extensions, models 37085 and 37086. the manufacturer issued a medical device safety notification for these extension models in april 2015, reinforcing device labeling specific to the handling of extensions and system integrity checking during implant procedures due to the fracture rate seen in extensions at that time. current labeling for the handling of the system during implant is described within the implant manuals. the manufacturer advises users to follow the instructions defined within the dbs pocket adaptor implant manual, specifically to ensure that the adaptor wire is not bent sharply or kinked at the time of implant.To minimize the potential for a conductor wire fracture in addition, users are advised to complete a system integrity check for proper electrode impedances prior to pocket closure, as described in the activa pc model 37601 implant manual. according to the local supplier, the affected products are distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 24 june 2016.

Device

Deep Brain Stimulation (DBS) system pocket adaptors
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Medtronic Neuromodulation Deep Brain Stimulation (DBS) system pocket adaptors
  • Manufacturer
    Medtronic Ltd

Manufacturer

Medtronic Ltd
  • 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