Events

pacemakers and Cardiac Resynchronization Therapy pacemakers - Minute Ventilation Signal Oversensing 의 안전성 경고

Department of Health에 따르면, 해당 안전성 경고 는 Hong Kong 에서 Boston Scientific 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
    2017-12-22
  • 사례 출판 날짜
    2017-12-22
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20171222c.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: boston scientific pacemakers and cardiac resynchronization therapy pacemakers - minute ventilation signal oversensing medical device manufacturer, boston scientific, has issued a medical device safety alert concerning its cardiac resynchronization therapy pacemakers (crt-ps). the affected crt devices are identified as the following:- valitude crt-p [models: u125 and u128] accolade pacemakers [models: l300, l301, l310, l311, l321, l331] essentio pacemakers [models: l100, l101, l110, l111, l121, l131] visionist crt-p [models: u225, u226 and u228] proponent pacemakers [models: l200, l201, l209, l210, l211, l221, l231] altrua 2 pacemakers [models: s701, s702, s722] the manufacturer has received reports of intermittent oversensing of the minute ventilation (mv) sensor signal with its certain pacemaker and cardiac resynchronization therapy pacemaker systems (pacemakers). mv sensor signal oversensing may cause pre-syncope or syncope due to periods of pacing inhibition. this mv behavior may occur with any manufacturer’s pacing lead system, but the manufacturer has determined it to be more likely for the affected pacemakers using medtronic or abbott/st. jude (abbott) leads implanted in either the right atrium (ra) or right ventricle (rv). according to the manufacturer, its pacemakers can be used for rightrate (rate adaptive pacing), respiratory rate trend, or ap scan. when the ra/rv pacing leads and lead terminal connections are operating as intended, the mv sensor signal is appropriately filtered and therefore is not detected by the pacemaker or displayed on electrograms (egms). however, intermittency related to the lead or pacemaker-lead connection has the potential to create a transient high impedance condition. a high impedance condition may subsequently alter the mv sensor signal such that it becomes visible on egms and potentially subject to oversensing on the ra or rv channels. the manufacturer is actively developing a software update designed to automatically detect and resolve this mv sensor signal oversensing behavior. 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 22 december 2017.

Device

pacemakers and Cardiac Resynchronization Therapy pacemakers - Minute Ventilation Signal Oversensing
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Boston Scientific pacemakers and Cardiac Resynchronization Therapy pacemakers - Minute Ventilation Signal Oversensing
  • Manufacturer
    Boston Scientific

Manufacturer

Boston Scientific
  • 제조사 모회사 (2017)
    Boston Scientific
  • 제조사 의견
    “We take a patient-first approach to assessing the applicability of every recall and communicate to regulatory bodies in all geographies where the recalled device is sold,” Boston Scientific said in a statement to ICIJ. “We have coordinated several recalls across many countries in a timely manner,” the company said, adding that it complies with all national laws, which can often vary and require different processes for reporting information or taking action on recalls. The company said it uses a rigorous and uniform process to take action on recalls and that “when we initiate a field action (e.g. recall, safety alert), every customer who has received an affected product receives a communication that includes a letter for the physician.”
  • Source
    DH