Events

COGNIS Implantable Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and TELIGEN DR & VR Implantable Cardioveter-Defibrillators (ICDs) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Boston Scientific 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-00906-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-08-29
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-00906-1
  • 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
    Boston scientific has determined that the performance of a low voltage capacitor in a subset of cognis crt-ds and teligen icds manufactured prior to december 2009 may be compromised over time, causing increased current drain that can lead to premature battery depletion. all cases reported to date have been detected by diagnostic tools within boston scientific’s safety architecture before device function was compromised. “safety architecture” refers to a set of diagnostic monitoring which periodically assess device performance, including battery voltage, power consumption, and charge time, and have proven effective in identifying instances of unexpected battery use (via programmer alert screens or replacement indicators) before therapy becomes unavailable.
  • 조치
    There are no additional clinical recommendations beyond the current standard of patient care and normal device monitoring. - Remind patients to contact the clinic if beeping is heard from their device, as instructed in the patient manual. - Physicians should promptly investigate alerts and unanticipated replacement indicator messages. - Following a Safety Architecture alert, contact Boston Scientific Technical Services as directed on programmer screens [24 hours per day / 7 days per week]. Technical Services can facilitate an evaluation of “save-to-disk” information (while the device is still implanted) to help clarify available replacement time. For more details, see http://www.tga.gov.au/safety/alerts-device-cognis-crt-d-and-teligen-icd-130903.htm .

Device

COGNIS Implantable Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and TELIGEN DR & VR ...
  • 모델명 / 제조번호(시리얼번호)
    COGNIS Implantable Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) and TELIGEN DR & VR Implantable Cardioveter-Defibrillators (ICDs)Affected model numbers: COGNIS CRT-D : N106, N107, N118, N119, P106, P107TELIGEN DR ICD: E110, F110TELIGEN VR ICD: E102, F102Manufactured prior to December 2009ARTG Numbers: 154034, 154033, 154039 & 154037
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    Boston Scientific Pty Ltd

Manufacturer

Boston Scientific Pty Ltd
  • 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
    DHTGA