Events

RELIANCE 4-FRONT 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
    2015-05-22
  • 사례 출판 날짜
    2015-05-22
  • 사례 국가
    Hong Kong
  • 사례 출처
    DH
  • 사례 출처 URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20150522a.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 reliance 4-front medical device manufacturer, boston scientific, has issued a medical device safety alert concerning reliance 4-front. the affected devices are identified as follows:- model numbers: 1) 0682; 2) 0692 serial numbers: 1) 121478, 121502, 121485, 121503, 121488, 121504, 121489, 121505, 121490, 121506, 121491, 121507, 121494, 121509, 121495, 121510, 121497, 121511, 121501, 121514; 2) 121454, 121466, 121481, 121516, 121527, 121455, 121467, 121482, 121517, 121528, 121456, 121468, 121483, 121519, 121530, 121458, 121469, 121484, 121520, 121531, 121459, 121470, 121487, 121521, 121532, 121460, 121472, 121492, 121522, 121533, 121461, 121473, 121493, 121523, 121534, 121462, 121475, 121496, 121524, 121538, 121463, 121476, 121508, 121525, 121540, 121464, 121477, 121515, 121526, 121541, 121465, 121479 according to the manufacturer, one lead of a subset of seventy-two boston scientific reliance 4-fronttm single coil defibrillation leads distributed in europe and japan exhibited intermittent high pacing impedance and oversensing at implant. laboratory analysis determined that the terminal ring for the distal shock electrode was not fully connected to the conductor cable. further investigation determined that manufacturing equipment used to attach the terminal ring to the conductor cable was slightly offset from the intended position for a short period of time. the seventy-two leads were manufactured during this offset period, and may have a terminal ring that was not fully connected to the conductor cable. if the terminal ring is not securely connected to the conductor cable, potential clinical symptoms may include high or intermittently high pacing or shock lead impedance, noisy electrograms (egms) (particularly during pocket manipulation), or sensing anomalies that could affect either pacing pulses or shocks. a terminal ring that is not fully connected to the conductor cable could cause clinical symptoms during the replacement procedure. according to the local supplier, the affected products are not distributed in hong kong. if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 22 may 2015.

Device

RELIANCE 4-FRONT
  • 모델명 / 제조번호(시리얼번호)
  • 제품 설명
    Medical Device Safety Alert: Boston Scientific RELIANCE 4-FRONT
  • 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