Events

Deep Brain Stimulation (DBS) Leads (implantable, neurological electrode stimulator) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Medtronic Australasia Pty Ltd 에 의해 제조된 제품과 관련되어 있습니다.

이것은 무엇인가요?

의료기기에 문제가 생겼을 경우 제조사가 이를 바로잡거나 시장에서 회수하는 조치를 말한다. 회수(Recall)는 의료기기에 결함이 있거나, 건강에 위협이 되거나, 또는 결함도 있고 건강에도 위협이 될 경우에 발생한다.

데이터에 대해 더 자세히 알아보기 여기
  • 사례 유형
    Recall
  • 사례 ID
    RC-2013-RN-00124-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-02-11
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00124-1
  • 비고 / 경고
    Australian data is current through July 2018. All of the data comes from the Australian Therapeutic Goods Administration, 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 Australia.
  • 데이터 추가 비고
  • 원인
    The proximal end of the dbs lead can be damaged when the connector block of the dbs lead cap twists within the assembly when turning the set screw during step 1 of dbs surgery. the damage would most likely occur at lead contact #3 which could affect electrode contact #3. there is a 5.0 in-oz requirement on the lead cap assembly specification. recent testing indicates that this requirement is not being met.
  • 조치
    Medtronic is working on a corrective action to reduce the occurrence of setscrew connector block twisting. It is recommended that the lead cap is not used until corrective actions are implemented. If it is imperative that the operation be carried out in a two stage procedure users are required to follow modified instructions: -Capping the Lead Step 4 - Any time you use a torque wrench, hold the setscrew connector block firmly between thumb and forefinger to prevent rotation of the block Step 5 - Tighten the single setscrew socket on the number 3 lead contact by turning it clockwise with the torque wrench provided. Tighten the setscrew until it touches the contact; then continue tightening for a maximum of 1/4 turn only (you may or may not hear the sound of a click). -Removing the Lead Cap Step 5 & 6 - Hold the setscrew connector block firmly between thumb and forefinger to prevent rotation. Failure to prevent rotation may break or damage the lead, and may require lead replacement.

Device

Deep Brain Stimulation (DBS) Leads (implantable, neurological electrode stimulator)
  • 모델명 / 제조번호(시리얼번호)
    Deep Brain Stimulation (DBS) Leads (implantable, neurological electrode stimulator)Model Number: 3387ARTG Number: 137374Model Number: 3389ARTG Number: 137138Model Number: 3391ARTG Number: 174469
  • 의료기기 분류등급
    Neurological Devices
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty 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
    DHTGA