Events

REPLY and ESPRIT Pacemakers interrogated using Orchestra and Orchestra Plus Programmers 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Sorin Group Australia 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-01229-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2013-11-22
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2013-RN-01229-1
  • 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
    There could be overestimation of the residual longevity displayed by the programmer during a follow-up exam of patients implanted with a reply or esprit pacemakers. because of this incorrect information, the follow-up dates might not have been adjusted when nearing the elective replacement indicator (eri). when the device approaches the eri, this overestimation of the residual longevity could result in eri or end of life (eol) being reached between two follow-up visits. please note that when the devices are programmed at high energy outputs (e.G. high pulse amplitude and width) associated to a high percentage of paced events, longevity can be reduced. no permanent injury or death has occurred as a result of the reported events. in all reported events, pacing functions were maintained at follow-up time.
  • 조치
    Sorin CRM is asking clinicians to implement the following patient management recommendations: - Consider checking the battery impedance of the last follow-up exam. In case the battery impedance is greater than or equal to 3.5k?, a follow-up visit must be scheduled within a maximum of 6 months from the last follow-up visit. -When pacemaker operation is checked by the simple application of a magnet, a magnet rate less than 95 min-1 should trigger a follow-up exam in the pacemaker centre. -As a general rule, a maximum of 6 month follow-up interval when the battery impedance becomes greater than or equal to 3.5 k?. This recommendation should also be followed subsequent to the installation of the new programmer software version. A new programmer software version (SmartView 2.40 version or higher) will be released to correct the time to ERI and its presentation through the color-coded gauge. Sorin representative will inform the users as soon as the software upgrade is available. For more details, please see http://tga.gov.au/safety/alerts-device-orchestra-devices-and-espirit-pacemakers-131129.htm .

Device

REPLY and ESPRIT Pacemakers interrogated using Orchestra and Orchestra Plus Programmers
  • 모델명 / 제조번호(시리얼번호)
    REPLY and ESPRIT Pacemakers interrogated using Orchestra and Orchestra Plus ProgrammersREPLY DR dual chamber pacemakerCatalogue Number: ICV1099ARTG Number:152879REPLY SR single chamber pacemakerCatalogue Number: ICV1119ARTG Number: 158733ESPRIT DR dual chamber pacemakerCatalogue Number: ICV1114ARTG Number:163898ESPRIT SR single chamber pacemakerCatalogue Number: ICV1125ARTG Number:163899
  • Manufacturer
    Sorin Group Australia

Manufacturer

Sorin Group Australia