Events

Platinium Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds) 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 LivaNova Australia 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-2017-RN-00913-1
  • 사례 위험등급
    Class III
  • 사례 시작날짜
    2017-08-17
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2017-RN-00913-1
  • 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
    Livanova has identified an issue of overconsumption following an electrostatic discharge (esd) during implant surgery or an mri scan.An electronic component in specific platinium devices has been found to be sensitive to esd, potentially generated during surgery. the discharge can trigger overconsumption of current, leading to reduced device longevity (5% loss per month). resetting the device will stop the overconsumption, but the residual longevity displayed by the programmer may be temporarily underestimated.Exposure to an mri's magnetic field can cause overconsumption, & the battery voltage will decrease to 2.80v. at this level, the remaining longevity is 25% of the initial longevity. to date, no permanent injury or death has occurred as a result of these issues. as of 16 june 2017, livanova has received 18 reports of overconsumption associated with esd exposure at implant, (0.19%), & 4 reports of overconsumption/premature device replacement attributed to mri (0.04%).
  • 조치
    In order to mitigate the potential risks associated with both triggering events (ESD/MRI scan), LivaNova recommends physicians follow-up patients at the periodicity already stated in the implant manual, especially: - Before the patient is discharged & at each subsequent follow-up, check the battery status & the occurrence of system warnings; - It is recommended that a routine follow-up examination be done 1 month after discharge, & then every 3 months until the device nears the replacement date. LivaNova does not recommend anticipating patient visits, provided that the IFU is followed. If the warning “[A3] Technical issue” is displayed, this indicates that the device is affected by the overconsumption caused by an ESD at implant. Without delay, contact your LivaNova representative who will organise the reset of the device. Complete and return the supplied Customer Reply Form ASAP. For further information, please see https://www.tga.gov.au/alert/platinum-icds-and-crt-ds

Device

Platinium Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibri...
  • 모델명 / 제조번호(시리얼번호)
    Platinium Implantable Cardiac Defibrillators (ICDs) and Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds)Platinium VR 1210Platinium VR 1240Platinium DR 1510Platinium DR 1540Platinium CRT-D 1711Platinium CRT-D 1741Platinium SONR CRT-D 1811Platinium SONR CRT-D 1841ARTG Numbers: 282817, 282816, 282818, 282819, 282820, 282821, 282822 and 282823
  • Manufacturer
    LivaNova Australia Pty Ltd

Manufacturer

LivaNova Australia Pty Ltd