Events

Viva Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds) and Evera Implantable Cardioverter Defibrillator (ICDs) Affected devices implanted in Australia:Evera XT VR ICD 의 리콜

Department of Health, Therapeutic Goods Administration에 따르면, 해당 리콜 는 Australia 에서 Medtronic Australasia 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-2016-RN-01078-1
  • 사례 위험등급
    Class I
  • 사례 시작날짜
    2016-08-24
  • 사례 국가
    Australia
  • 사례 출처
    DHTGA
  • 사례 출처 URL
    https://apps.tga.gov.au/Prod/sara/arn-detail.aspx?k=RC-2016-RN-01078-1
  • 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
    An issue has been identified with certain devices that were manufactured with a specific subset of circuit components. devices in the affected population may experience rapid battery depletion due to a low resistance path developing within the circuit component. development of a low resistance path in the circuit component in some cases has been reported to cause battery depletion in seven (7) days or less and may present clinically during a patient follow-up visit as:- one or more electrical resets, which will display as an observation on the programmer.- no pacing or defibrillation therapy output.- no telemetry.- programmer screen display of serious device memory failure.Patient audible alerts and carealerts may not reliably notify the patient or clinician. within these 78 devices there have been seven (7) confirmed failures (9%) through july 16, 2016. reported complications have included shortness of breath, pocket heating, low heart rate, and early device explant.
  • 조치
    Physicians are asked to advise patients to seek medical attention immediately if they experience symptoms (e.g., fainting or light-headedness) or if the audible patient alert sounds. For pacemaker-dependent patients or those at a higher risk of Ventricular Tachycardia or Ventricular Fibrillation, Physicians should consider device replacement. For other patients, Medtronic is recommending: · Program the audible alerts for “Low Battery Voltage RRT” to “On-High”. It is possible that alerts may not sound if the battery is depleted. Therefore physicians should also consider one of the following: - Provide a handheld magnet to patients to frequently check device status. - Prescribe either a CareLink transmission be performed by the patient, or a maintenance transmission by the clinic, on a more frequent basis (e.g., weekly or daily) based on the unique patient considerations. Medtronic is offering the above additional options at no cost.

Device

Viva Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds) and Evera Implantable Cardioverter...
  • 모델명 / 제조번호(시리얼번호)
    Viva Cardiac Resynchronisation Therapy Defibrillators (CRT-Ds) and Evera Implantable Cardioverter Defibrillator (ICDs)Affected devices implanted in Australia:Evera XT VR ICD Model: DVBB2D4Serial numbers: BWJ601108S, BWJ601112S, BWJ601479S ARTG number: 208027
  • 의료기기 분류등급
    Cardiovascular Devices
  • Manufacturer
    Medtronic Australasia Pty Ltd

Manufacturer

Medtronic Australasia Pty Ltd
  • 제조사 모회사 (2017)
    Medtronic plc
  • 제조사 의견
    “If our surveillance systems identify a potential performance issue, our personnel promptly evaluate the problem, including, when appropriate, conducting root cause investigations and internal testing to assess whether the product continues to meet specifications and defined performance criteria,” Medtronic told ICIJ in a statement. “In some cases, based on this evaluation, Medtronic may determine that a recall is necessary.” The company said that it communicates with healthcare providers and/or patients and provide recommendations to address such issues. Medtronic noted that these communications can include letters, emails, calls, press releases, physician notifications and social media postings, as well as informing the FDA and other regulators of the actions.
  • Source
    DHTGA